Merry Christmas & a very happy new year to all the readers of IP Pharma doc

Merry Christmas & a very happy new year to all the readers of IP Pharma doc

Regards,

DKS

Quetiapine Fumarate: Teva got tentative approval

Teva Pharma announced today that the United States Food and Drug Administration (USFDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of AstraZeneca's antipsychotic agent Seroquel® (Quetiapine Fumarate) Tablets, Eq. 25 mg base, 50 mg base, 100 mg base, 150 mg base, 200 mg base, 300 mg base and 400 mg base.

The brand product had annual sales of approximately $3.8 billion in the United States for the twelve months that ended September 30, 2008, based on IMS sales data.

It is pertinent to mention here that generic players like Teva and Sandoz tried to invalidate inoovator Astra’s Orange Book listed product patent US4879288 (Expiry: September 26, 2011) in New Jersey District court. However, court upheld the validity of said patent. Teva can launch its generic version of Quetiapine after September 26, 2011.

DOXYCYCLINE HYCLATE (DORYX): Innovator Warner Chilcott Sued 3 generic companies

Innovator, Warner Chilcott Limited confirmed that one of the Company's subsidiaries and Hospira, have received Paragraph IV Certification Notices from generic players Imopax, Mutual Pharma and Mylan Pharma, wherein, these companies has filed an Abbreviated New Drug Application (ANDA) for generic versions of DORYX 100 and 75 mg delayed-release tablets. Both generic companies have challenged recently listed following Orange Book Patent:US6958161 (Expiry: Dec 15, 2022): Which covers a modified release preparation having one or more coated core elements, each core element comprising an active ingredient selected from the group consisting of the acid salts of Doxycycline, Tetracycline, Oxytetracycline, Minocycline, Chlortetracycline or Demeclocycline and having a modified release coating, wherein a stabilising coat is provided between each core element and its modified release coating so that, upon in vitro dissolution testing, the amount of active ingredient released at any time on a post-storage dissolution profile is within 40 percentage points of the amount of active ingredient released at any time on a pre-storage dissolution profile.

Innovator has sued these companies in New Jersey District court for the infringement of ‘161 patent.

Desloratadine (Clarinex): Dr. Reddy settled with innovator

Dr. Reddy's Laboratories today announced Here that it has entered into agreements with Schering and Sepracor, which will allow Dr. Reddy’s to manufacture and market generic versions of the CLARINEX-D®-12 Hour and CLARINEX-D® -24 Hour products, with six months marketing exclusivity, and the CLARINEX® REDITABS® product, with six months marketing co-exclusivity, starting in 2012. Dr. Reddy’s will also market a generic version of the CLARINEX® 5 milligram tablet six months after the launch of the first generic version of that product.
The agreements resolve all pending patent infringement actions filed by Schering and Sepracor against Dr. Reddy’s in the U.S. District Court for the District of New Jersey.

As reported earlier by IPPharma doc that innovator has settled there pending litigation with other generic players like Perrigo, Ranbaxy and Lupin.

Update

Link to business-standard news on recent success of Dr. Reddy in Germany and other markets here

Atorvastatin Hemicalcium (Lipitor): Pfizer sued Apotex for filing ANDA with Para IV certification

Innovator Pfizer sued Canadian pharma giant Apotex (as per complaint filed on December, 17, 2008 in federal court in Wilmington, Delaware) for filing ANDA with Para IV certification to United States Food and Drug Administration (USFDA) to import and sell 10, 20, 40 and 80 mg/tablet dosage strengths of the Atorvastatin Hemicalcium, in violation of a enantiomer patent listed in Orange Book.

Apotex has filed Para IV against following Orange Book listed patents:
US4681893 (Expiry: 24 March, 2010)- Covers racemic form of Atorvastatin generically.
Litigation update: Ranbaxy was unsuccessful in invalidating the said patent in US Court of Appeals For Federal Circuit (CAFC) in 2006. Further, during recent reexamination of ‘893 by USPTO on request from a Law firm representing Ranbaxy, the USPTO as per their May 2008 decision upheld the validity of ‘893 patent. Earlier, Teva and cobalt has filed Para III against this patent. Probably, Apotex has also filed Para III against said patent
US5273995 (Expiry: 28th June, 2011) -Covers Atorvastatin enantiomer and salts as Product (Specifically)
Litigation update:
1. The patent was invalidated by CAFC in August 2006

2. Pfizer applied for reissue of the patent to USPTO, which was rejected twice by USPTO. On April 2008, USPTO again rejected Pfizer request

3. In Caudet litigation Pfizer stated that it had issued ‘covenant not to sue’ (will not sue Ranbaxy for the infringement of said patent) to Ranbaxy, in case ‘995 patent is reissued to Pfizer

4. Innovator Pfizer sued Cobalt and Teva for the infringement of ‘995 patent

5. On 15 May 2008, Court entered Judgment in favor of Pfizer and delayed Cobalt ANDA approval till expiry of ‘995 patent
6. On Dec 17, 2008, Innovator sued Apotex for the infringement of ‘995 patent

US5686104 (Expiry: 11th May, 2015)- Covers stable Formulation
Litigation update: Pfizer has sued cobalt but not asserted patent during trial

US5969156 (Expiry: 8th June, 2017)- Polymorph (Form I, II and IV) Litigation update: Pfizer has sued cobalt but not asserted patent during trial
US6126971 (Expiry: 19th July, 2013)- Covers Formulation Litigation update: Pfizer has sued cobalt but not asserted patent during trial

Further, Pfizer has sued Apotex for the infringement of ‘995 patent only and have not asserted other patents in the complaint

Earlier, Innovator had sued Teva, Cobalt and Ranbaxy for this product, however, Cobalt and Ranbaxy have setlled there pending litigation with innovator.
Furthermore, Ranbaxy settled with innovator Pfizer on Lipitor and Caudet on June 18, 2008. Pharma giant Pfizer and Ranbaxy agreed to keep generic version of the cholesterol lowering drug Atorvastatin off the U.S. market with an extra 20 months exclusivity for Pfizer. Under the terms of the agreement, Ranbaxy will have a license to sell generic versions of Atorvastatin and Caudet (Atorvastatin-Amlodipine Besylate) in the United States effective Nov. 30, 2011. Since, Ranbaxy has first to file 180 days exclusivity for this product, accordingly, other generic players will enter into the market from June, 2012 onwards.
Also, Apotex and Pfizer were in litigation w.r.t Lipitor in Canada, however, in August, 2008, both settled there pending patent litigation in Canada. (As reported earlier by IPPharmdoc Here)
Link to Bloomberg news

Cutivate (Fluticasone propionate): Innovator sued Glenmark generics for filing ANDA with Para IV certification

Innovator Nycomed U.S. has filed a patent infringement lawsuit in the United States against Glenmark Generics, after receipt of Para IV notice letter from Glenmark on generic version of Nycomed's Cutivate (Fluticasone propionate) skin lotion. Glenmark has filed ANDA with Para IV certification against following Orange Book listed patent:
US7300669 (Assignee: Altana, Issued on: November 27, 2007 , Expiry: Oct 20, 2019): Which covers a topical lotion, comprising: about 0.005 to 1.0 wt. % fluticasone, or a pharmaceutically acceptable salt or ester thereof; about 4.0 to 6.0 wt. % of a C14-C20 fatty alcohol or mixtures thereof; about 1.0 to 5.0 wt. % of at least one first skin conditioning agent; about 5.0 to 15.0 wt. % propylene glycol; and the balance in water; wherein the lotion is free of mineral oil and white soft paraffin, and wherein the lotion causes more vasoconstriction when applied to living human skin than does application of a cream containing mineral oil or soft white paraffin, or both, the cream containing the same amount of the fluticasone or the pharmaceutically acceptable salt or ester thereof.
Innovator Nycomed got approval for this product on March 31, 2005.
Fluticasone propionate is a steroid having anti-inflammatory, anti-pruitic, and vasoconstrictive properties

Clarinex (Desloratadine): Lupin settled patent dispute with innovator

Indian Pharma compnay Lupin has settled a patent dispute with innovator Schering-Plough Corp. over that company's allergy drug Clarinex (Desloratadine).
Under the settlement, Lupin said it would be able to sell a generic version of the drug starting July 1, 2012.
Earlier, innovator Schering sued Lupin for patent infringement of US6100274 (which covers Stable formulation), US7214683 (which covers formulation of descarboethoxyloratadine) and US7214684 (method of use of descarboethoxyloratadine) based upon its filing of an ANDA containing a Paragraph IV certification.
Earlier, innovator had sued various generic players like Zydus, Sandoz, Mylan, Orchid, Perrigo, Glenmark, GeoPharma, Lupin, Ranbaxy, Sun, Watson, Dr. Reddy's who filed ANDA to market this product. Importantly, Innovator has patents listed in orange Book with expiries in 2020. Apart from Lupin, innovator had settled with Perrigo, Watson Pharma and Ranbaxy. Possibly, all generic players are in licensing agreement with Innovator

Data Exclusivity in Canada: Generic drug maker suit against federal government reaches trial stage

Federal regulations that bar Canada's generic drug makers from copying brand-name products for eight years after patents expire will come under the judicial microscope Tuesday as a two-year-old lawsuit reaches Federal Court.
The generic drug makers want the court to set aside rules that they argue cost consumers $115 million in extra drug costs every year.
Link to full article by Canadian Press Here

Clopidogrel bisulfate: CAFC affirmed district court's decision and upheld product patent

Innovator Sanofi-aventis and Bristol-Myers Squibb announced Here that the U.S. Court of Appeals for the Federal Circuit has upheld the June 19, 2007 decision by the U.S. District Court for the Southern District of New York holding the product patent covering clopidogrel bisulphate, the active ingredient in Plavix®, valid and enforceable.
Apotex filed an ANDA for a generic version of Plavix (Clopidogrel bisulfate) with a paragraph IV certification in early 2001 and was subsequently sued by innovator Sanofi-Synthelabo and Bristol-Myers Squibb (BMS) for infringement of following product patent listed in Orange book,
US4847265 (Expiring on Nov 17, 2011)-which covers Dextro-rotatory isomer of methyl alpha-5(4,5,6,7-tetrahydro(3,2-c)thieno pyridyl) (2-chlorophenyl)-acetate substantially separated from the levo-rotatory isomer and its pharmaceutically acceptable salts
The 30 month stay on Apotex ANDA approval expired in 2005 and its ANDA was subsequently approved in 2006. Apotex launched its product at risk with 180 days exclusivity but was enjoined after 23 days by preliminary injunction by District court on appeal from innovator. Later, US district court upheld the validity of disputed patent. Subsequently, Apotex appealed against the decision in CAFC, which upheld the district court’s decision. As a result of this ruling, the '265 patent protection for this product is maintained in the United States until November 2011.
Decision of Court of appeal for federal circuit Here

Trusopt (Dorzolamide) & Cosopt (Dorzolamide & Timolol): Court upheld USFDA’s decsion on 180 days exclusivity denial to Hi-Tech

Hi-Tech Pharmacal announced that the United States District Court denied Hi-Tech's motion for a preliminary injunction, permanent injunction, and declaratory judgment, and granted Apotex's motion for summary judgment, and entered summary judgment in favor of the USFDA.

Hi-Tech had challenged the FDA's ruling that the Company had forfeited an exclusive generic marketing period for the Company's Dorzolamide and Timolol ophthalmic solution ANDA. Hi-Tech launched Dorzolamide and Timolol on October 28, 2008 and continues to market the product.

Update

Hi-tech was first ANDA filer for Trusopt (Dorzolamide) & Cosopt (Dorzolamide & Timolol) by filing Para IV against following Orange Book listed patents on Oct 11, 2005.

US4797413 (Expiry: Oct 28, 2008)

US6248735 (Disclaimed)

US6316443 (Disclaimed)

Earlier on January 18, 2006 innovator Merck sued Hi-tech for the infringement of ‘413 patent (the other two patents were disclaimed by innovator under 35 USC 253) . On April 2006, court gave decision in favor of innovator Merck (which was also affirmed by CAFC on March 29,2007) and delayed ANDA proval of Hi-tech till expiry of ‘413 patent. However, Hitech got 180 days exclusivity based on Para IV filing agiant ‘735 and ‘443 patents. The USFDA has denied Hitech pharma 180 days exclusivity for Cosopt (Dorzolamide hydrochloride & Timolol maleate) due to failure to market provision.Apotex also filed ANDA against innovator’s Orange Book listed patent ‘413 but it also sought to file Para IV against ‘735 and ‘443, which were disclaimed by innovator at the time of Apotex’s ANDA filing. Apotex was sued by innovator on December 4, 2006 for he infringement of ‘413 patent. However, Apotex counter claimed for declaratory judgment of noninfringement/invalidity w.r.t disclaimed patents ‘735 and ‘443.The CAFC concluded that there is no article III controversy and dismissed Apotex’s complaint and its attempt to trigger Hitech’s 180 days exclusivity

Valganciclovir (Valcyte): Setback to Cipla in trademark infringement case

Innovator Hoffman-La Roche won a partial victory in its legal battle against India’s Cipla Ltd over anti-infection drug valganciclovir, with the Bombay high court ruling in favour of the Swiss company in a trademark infringement case. Mumbai high Court has stopped Cipla from using Valcept trade name as it’s similar to trade name Valcyte used by innovator Roche.
However, the court adjourned a patent infringement case for eight weeks because Roche’s patent on the drug itself has been set aside by the Madras high court till 31 January. A Tamilnaidu based NGO has filed pre-grant opposition against Roche’s patent on valganciclovir.
Source: Livemint news Here

DOXYCYCLINE HYCLATE (DORYX): Warner Chilcott Announces Receipt of Paragraph IV Certification Notices

Innovator, Warner Chilcott Limited confirmed that one of the Company's subsidiaries and Hospira, have received Paragraph IV Certification Notices from generic players Mutual Pharma and Mylan Pharma, wherein, these companies has filed an Abbreviated New Drug Application (ANDA) for generic versions of DORYX 100 and 75 mg delayed-release tablets. Both generic companies have challenged recently listed following Orange Book Patent:
US6958161 (Expiry: Dec 15, 2022): Which covers a modified release preparation having one or more coated core elements, each core element comprising an active ingredient selected from the group consisting of the acid salts of Doxycycline, Tetracycline, Oxytetracycline, Minocycline, Chlortetracycline or Demeclocycline and having a modified release coating, wherein a stabilising coat is provided between each core element and its modified release coating so that, upon in vitro dissolution testing, the amount of active ingredient released at any time on a post-storage dissolution profile is within 40 percentage points of the amount of active ingredient released at any time on a pre-storage dissolution profile
DOXYCYCLINE HYCLATE (DORYX), which the Company markets and sells in 150, 100 and 75 mg strengths in the United States under a license agreement with Hospira's subsidiary, Mayne Pharma, is a tetracycline-class oral antibiotic. The '161 Patent has been listed in the FDA's Orange Book pursuant to the transition provisions of the QI Program Supplemental Funding Act of 2008 enacted October 8, 2008 (Wherein, antibiotic product approved before November, 1997 will have Orange Book listing and innovator companies has 60 days time to list patent for old antibiotics. Furthermore, innovator companies have time till Dec 7, 2008 to list such patents. Earlier, Orange book patent listing was not applicable for old antibiotics).
The Company and Mayne are currently reviewing the detail of the Paragraph IV Certification Notices from Mutual and Mylan and continue to have full confidence in the intellectual property protecting DORYX.
Earlier, innovator got approval to market this product from USFDA on May 6, 2005.
Press release from Warner Chilcott Here

Stalevo (Carbidopa+Entacapone+Levodopa: 12.5+200+50 mg ): Innovator sued Wockhardt

Innovator Orion announced Here that they had sued generic player Wockhardt for filing Para IV certification against Orange Book listed patents for Stalevo (Carbidopa+Entacapone+Levodopa: 12.5+200+50 mg ) in the United States.
As reported earlier by IPPharmadoc Here, Wockhardt send Para IV notice letter for this product to innovator in November this year.
Following patents are listed in orange book for this product:

US4963590 (Expiry: Nov 27, 2007): Claims Pharmaceutical composition and method of use of catechol-O-methyl transferase inhibitor
US5112861 (Expiry: May 12, 2009): Method of use with Entacapone and levodopa
US5135950 (Expiry: Oct 31, 2010): Crystallographically essentially pure polymorphic form A
US5446194 (Expiry: Oct 19, 2013): Covers Entacapone as product
US6500867(Expiry: Jun 29, 2020): Covers An oral solid tablet composition comprising pharmacologically effective amounts of Entacapone, Levodopa, and Carbidopa, or pharmaceutically acceptable salts or hydrates thereof, and a pharmaceutically acceptable excipient, wherein a substantial portion of carbidopa or a pharmaceutically acceptable salt or hydrate thereof is separated from entacapone and levodopa or pharmaceutically acceptable salts or hydrates thereof in the tablet.

US6797732 (Expiry: Jun 29, 2020): A stable oral solid composition comprising pharmacologically effective amounts of active agents consisting of Entacapone, Levodopa, and Carbidopa, or pharmaceutically acceptable salts or hydrates thereof, and comprising at least one pharmaceutically acceptable excipient other than microcrystalline cellulose

Wockhardt has challenged innovator’s ‘950, ‘194‘, 867 and ‘732 patents listed in the Orange Book. Innovator in it’s complaint has alleged infringement of ‘950, ‘194 and ‘867 patents. Earlier in January this year, another Indian drug major, Sun Pharmaceutical Industries, had challenged three patents of Stalevo. The latest of Stalevo's six US patents are to expire by October 31, 2010. The drug was given marketing permission by the USFDA in June 2003.

Update

Innovator Orion announced (Here) that they have also received Para IV notice letter from Wockhardt against other strengths of Stalevo (Carbidopa+Entacapone+Levodopa) like 25+200+100; 37.5+200+150 and 50+200+200 mg strengths

CALCITONIN SALMON (Fortical): Court blocked Apotex’s generic version till final decision on validity and infringement of formulation patent

Innovator Unigen announced (Here) that United States District Court for the Southern District of New York entered a preliminary injunction against generic player Apotex from launching generic version of Unigen and UPSHER SMITH’s CALCITONIN SALMON 200 IU/SPRAY (Fortical) in U.S market, till court decide the validity and infringement of following Orange Book listed patent:
US6440392 (Expiry: Feb 2, 2021): Which covers a liquid pharmaceutical composition comprising calcitonin or an acid addition salt thereof and citric acid and/or salt thereof in a concentration from 10 to about 50 mM, said composition being in a form suitable for nasal administration.
Apotex filed its ANDA with Paragraph IV certification against ‘392 in 2006, subsequently, innovator sued Apotex in New York district court, accordingly, ANDA approval process of Apotex was blocked for 30 months. After the expiry of 30 months stay on ANDA approval, Apotex received final approval from USFDA on Nov 17, 2008 and was ready to launch this product in US market at risk.
Earlier, USFDA approved innovator UPSHER SMITH’s Fortical formulation on Aug 12, 2005

Desloratadine tablets (5 mg): Perrigo settled with innovator

Perrigo pharma has announced (in a press release Here) that patent litigation w.r.t Desloratadine tablets (5 mg) has been settled with innovator Schering. Perrigo has got license from innovator for this product. Earlier, innovator Schering sued Perrigo for patent infringement of US6100274 (which covers Stable formulation), US7214683 (which covers formulation of descarboethoxyloratadine) and US7214684 (method of use of descarboethoxyloratadine) based upon its filing of an ANDA containing a Paragraph IV certification. Under the terms of the settlement, Perrigo can commercially launch its generic Desloratadine product on July 1, 2012, or earlier in certain circumstances. The new product launch may be a prescription or over-the-counter (OTC) product depending on its status at the time of launch. The Perrigo product is awaiting USFDA approval.

Earlier, innovator had sued various generic players like Zydus, Sandoz, Mylan, Orchid, Perrigo, Glenmark, GeoPharma, Lupin, Ranbaxy, Sun, Watson, Dr. Reddy's who filed ANDA to market this product.

Earlier news of Ippharmadoc on this product Here

Fenofibrate (Antara) Casules 130 and 43 mg: Lupin challenged formulation patent

Innovator Oscient Pharma and Ethypharm SA, have confirmed the receipt of Paragraph IV certification notice letter from Lupin Limited, wherein, Lupin has submitted ANDA with the USFDA for ANTARA® (fenofibrate) capsules, 130 and 43 mg. Lupin has filed para IV against following Orange Book listed patent:

US7101574 (Expiry: Aug 20, 2020): which covers a pharmaceutical composition in the form of granules, wherein each granule comprises a neutral microgranule on which is a composition comprising: micronized fenofibrate, a surfactant, and a binding cellulose derivative as a solubilization adjuvant, and wherein said fenofibrate is present in an amount greater than or equal to 60% by weight, relative to the weight of said pharmaceutical composition, and further wherein said binding cellulose derivative represents between 2 to 15% by weight, relative to the weight of said pharmaceutical composition.

Innovator Oscient and Ethypharm have 45 days to initiate a patent infringement lawsuit against Lupin to block Lupin’s ANDA approval process for 30 months.

Drug Approvals

Pamidronate Disodium Injection: Cipla, GeneraMedix, Hospira, Teva Parenteral
Synthetic Conjugated Estrogens Vaginal Cream: Duramed Research
Irinotecan Hydrochloride Injection: Teva Parenteral, Accord Healthcare
Risperidone Oral Solution: Apotex (Tentative Approval)
Methylprednisolone Sodium Succinate Injection: Hemopharm
Amoxicillin and Clavulanate Potassium Oral Suspension: Morton Grove Pharmaceuticals
Budesonide Inhalation Suspension: IVAX Pharmaceuticals
Divalproex Sodium Delayed-release Tablets: Orchid Healthcare
Lactulose Oral or Rectal Solution: ANI Pharmaceuticals
Metformin Hydrochloride Tablets: Indicus Pharma
Methylergonovine Maleate Injection: PharmaForce, Inc
Ofloxacin Ophthalmic Solution: Sandoz Inc
Olanzapine Tablets:Roxane Labs (Tentative Approval)
Selzentry (maraviroc) Tablets: Pfizer Inc., Accelerated Approval
Zolpidem Tartrate Tablets: Vintage Pharmaceuticals
Zaleplon Capsules: West-ward Pharmaceutical
(Source: USFDA)

Letrozole (Femara): Mylan settled with innovator

Mylan pharma announced in a press release Here, that Mylan have settled with innovator Nowartis with respect to their pending patent litigation on Letrozole tablets pending at New Jersy District court since June, 2006. Mylan in a bid to market generic version of Novartis's Femara (Letrozole) tablets 2.5 mg, filed ANDA in 2006. Subsequently, innovator sued Mylan in New Jersy District court for the infringement of US4978672 (Expiry: June 3,2011): Which covers Alpha-heterocyclc substituted tolunitriles as product (including Letrozole)

Under the agreement, Mylan is provided a patent license that will enable the company to market Letrozole Tablets, 2.5 mg, prior to the expiration of '672 patent. Additional terms related to the settlement remain confidential, and the agreement is subject to review by the U.S. Department of Justice and the Federal Trade Commission.

Accordingly, an early generic launch by Mylan is on the cards.

Irinotecan Hydrochloride: ScinoPharm got novel polymorph patent

ScinoPharm, an active pharmaceutical ingredient (API) specialist, has been granted US7435818 which covers a crystalline form of Irinotecan hydrochloride having a powder X-ray diffraction pattern with peaks at 20.3956.+-.0.2, 22.2950.+-.0.2, 12.0744.+-.0.2, 8.4800.+-.0.2, and 11.8306.+-.0.2 degrees in two theta. The said patent covers crystalline form I, II, III and IV of 7-ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin monohydrochloride trihydrate (irinotecan hydrochloride).

Details are Here

Generic companies raided by European Union regulators as part of an antitrust investigation

The settlement between generic and innovator companies regarding delaying generic entry is hurting EU regulators. Accordingly, Teva Pharmaceutical Industries Ltd., the world's biggest generic-drug maker, France's Les Laboratoires Servier and Slovenia's Krka Group d.d. have been raided by European Union regulators as part of an antitrust investigation.
Details are Here
link to CNN
Link to reuter news
Link to Bloomber

The European Commission is investigating patent settlements around Servier’s blood pressure medicine Perindopril as part of its probe into suspected anti-competitive practices launched last week. Here

Link to EU comissions's preliminary report on competition in pharmaceutical market Here

Cyclobenzaprine hydrochloride Extended-Release Capsules (AMRIX): Innovator sued Barr and Mylan

Innovator Cephalon and Eurand today announced (Here) that they have filed a lawsuit in U.S. District Court in Delaware against Mylan Pharma and Barr Pharma for infringement of Eurand's following Orange book listed patent:
US7387793 (Expiry: February 26, 2025): Which covers a multi-particulate pharmaceutical dosage form of a skeletal muscle relaxant providing a modified release profile comprising a population of extended release beads, wherein said extended release beads comprise an active-containing core particle comprising a skeletal muscle relaxant selected from the group consisting of cyclobenzaprine, pharmaceutically acceptable salts or derivatives thereof and mixtures thereof; and an extended release coating comprising a water insoluble polymer membrane surrounding said core, wherein said dosage form when dissolution tested using United States Pharmacopoeia Apparatus 2 (paddles @ 50 rpm) in 900 mL of 0.1N HCl at 37.degree. C. exhibits a drug release profile substantially corresponding to the following pattern: after 2 hours, no more than about 40% of the total active is released; after 4 hours, from about 40-65% of the total active is released after 8 hours, from about 60-85% of the total active is released; wherein said dosage form provides therapeutically effective plasma concentration over a period of 24 hours to treat muscle spasm associated with painful musculoskeletal conditions when administered to a patient in need thereof; and wherein said water insoluble polymer membrane comprises a water insoluble polymer selected from the group consisting of ethers of cellulose, esters of cellulose, cellulose acetate, ethyl cellulose, polyvinyl acetate, neutral copolymers based on ethylacrylate and methylmethacrylate, copolymers of acrylic and methacrylic acid esters with quaternary ammonium groups, pH-insensitive ammonio methacrylic acid copolymers, and mixtures thereof; and a plasticizer selected from the group consisting of triacetin, tributyl citrate, tri-ethyl citrate, acetyl tri-n-butyl citrate, diethyl phthalate, dibutyl sebacate, polyethylene glycol, polypropylene glycol, castor oil, acetylated mono- and di-glycerides and mixtures thereof.
‘793 patent is listed for 15 mg and 30 mg strengths of AMRIX (cyclobenzaprine hydrochloride extended-release capsules). Eurand developed AMRIX based on its patented and proprietary drug delivery formulation technologies. Cephalon is the exclusive licensee and marketer of AMRIX in the United States. USFDA approved innovator’s product on Feb 1, 2007.Further, Cephalon has 3 years of marketing exclusivity (New dosage Form exclusivity) preventing USFDA approval of a generic version of AMRIX until February 1, 2010.

Watson Enters Into Agreement to Acquire Products Related to Teva's Proposed Acquisition of Barr

Watson Pharma announced a definitive agreement to acquire a portfolio of generic pharmaceutical products that are being divested as a result of the proposed merger between Teva Pharma, and Barr Pharma. The closing of the product acquisition is contingent upon the consummation of Teva's merger with Barr.
The portfolio of products consists of 17 products, including 15 FDA-approved products and 2 development-stage products. Key products in the portfolio include:

Cyclosporine Capsules and Liquid

Desmopressin Acetate Tablets

Glipizide/Metformin HCl Tablets

Mirtazapine Orally Disintegrating Tablets

Metoclopramide HCl Tablets

Source: Watson press release Here

Budesonide (Pulmicort) Respules: Innovator AstraZeneca Settled Patent Litigation with Teva; Generic launch delayed till Dec, 2009

AstraZeneca today announced (in a press release Here) settlement agreement in its Pulmicort Respules patent infringement litigation against Ivax Pharmaceuticals, Inc., a wholly owned subsidiary of Teva Pharmaceuticals USA.
The agreement settles the patent infringement litigation (reported earlier by IPPharmadoc Here)
filed by AstraZeneca following Teva’s submission to the USFDA an Abbreviated New Drug Application for a generic version of Pulmicort Respules. Under the settlement agreement, Teva concedes that the patents asserted by AstraZeneca in the patent litigation are valid and enforceable. Teva also concedes that its generic version of Pulmicort Respules infringes AstraZeneca’s patents.The settlement agreement will allow Teva to commence sales of budesonide inhalation suspension, a generic version of Pulmicort Respules, under an exclusive license from AstraZeneca beginning 15 December 2009. AstraZeneca will receive a significant undisclosed royalty on sales of Teva's product, with a marked step down in payments if additional at-risk generic products enter the marketplace. Teva also agrees to pay AstraZeneca an undisclosed sum in respect of damages resulting from the unauthorised launch of its generic budesonide inhalation suspension product on 18 November 2008. Except as described, the terms of the settlement are confidential. The agreement releases Teva from all past US sales of its generic budesonide inhalation suspension and provides that any product already shipped by Teva will remain in the market to be further distributed and dispensed.AstraZeneca intends to continue to sell Pulmicort Respules, even after the licensed entry of Teva’s product in December 2009. However, the separate agreement between AstraZeneca and Par Pharmaceuticals to make available an authorized generic version of Pulmicort Respules will be discontinued.AstraZeneca and Teva have filed a Consent Judgment with the US District Court for the District of New Jersey reflecting the terms of the settlement agreement. With the Court now having entered the Consent Judgment, the settlement agreement is final, and the patent infringement litigation against Teva has been dismissed.With this announcement AstraZeneca confirms that it continues to expect Core earnings per share in the range of $4.90 to $5.05 for the full year 2008. Actual performance within this range is dependent upon the performance of the business for the remainder of the year, including the potential negative impact on sales of Pulmicort Respules from Teva’s generic product and the small amount of authorised generic already in trade channels. AstraZeneca will address the 2009 outlook for Pulmicort Respules as part of the full year 2009 guidance in January.AstraZeneca’s Pulmicort Respules patent infringement litigation against Breath Limited remains ongoing. In compliance with the Medicare Modernization Act of 2003, AstraZeneca will file all of the above agreements with the United States Federal Trade Commission and the United States Department of Justice.AstraZeneca’s patents protecting Pulmicort Respules have expiration dates that extend through 2018, with pediatric exclusivity through 2019. (Source: Astra press release)

Pramipexole Dihydrochloride(Mirapexin): Synthon successfully completes European decentralized procedures for generic version

Generic player Synthon announced (in a press release here) that it has successfully completed multiple decentralized procedures (DCP) for Pramipexole tablets. The Regulatory clearance has been obtained by Synthon in thirteen European countries. Synthon will market Pramipexole through its marketing partners in the following five strengths: 0.125 mg; 0.25 mg; 0.5 mg; 1.0 mg and 1.5 mg of Pramipexole dihydrochloride tablets.
Synthon is currently licensing out this product in Europe. The company has several free marketing authorizations available for new marketing partners. Pramipexole (known in Europe under the trade names Sifrol® and Mirapexin® and in the U.S.A. as Mirapex®), is a compound from Boehringer Ingelheim research first licensed in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson`s Disease, as monotherapy or in combination with levodopa. In Europe, sales of Pramipexole were € 321 million in 2007 with a 29% annual growth (IMS Midas data).
Earlier news of IPPharmadoc on Pramipexole Here

Sumatriptan succinate (Imitrex): Dr. Reddy's Launched Authorized Generic

Dr. Reddy's Labs announced (Here) that it has launched the authorized generic version of GlaxoSmithKline's Imitrex® (sumatriptan succinate) tablets 25mg, 50mg, and 100mg in the United States. Dr. Reddy's is the first company to launch an authorized generic version of Imitrex® tablets in the US market.
In October 2006, the Company announced that it had settled patent litigation with GlaxoSmithKline relating to sumatriptan succinate tablets, the generic version of GlaxoSmithKline Imitrex® tablets. The specific financial terms and conditions of the settlement have not been disclosed.
Eralier, innovator settled with generic companies like Ranbaxy and Dr. Reddy’s by allowing an authorized generic version to these two companies. Ranbaxy will launch its authorized generic version in December 2008. Another generic players Cobalt will launch its product in first quarter of 2009 ie before the expiry of US5037845 (Expiry: Feb 6, 2009): which covers Sumatriptan as product.
GlaxoSmithKline Imitrex® tablets, which are indicated for the acute treatment of migraine attacks in adults, had U.S. sales of $1.29 billion for the 12 month period ending December, 2007 according to IMS.

Nebivolol (Bystolic): USPTO Confirms Validity of Product Patent

Forest Lab announced Here today that the U.S. Patent and Trademark Office ("USPTO") has closed prosecution on the merits of the reexamination proceedings for the patent for Bystolic(R) and confirmed the validity of all of the previously granted claims. As a result, the USPTO has issued a Notice of Intent to Issue Ex Parte Reexamination Certificate for US6545040 (which covers a composition consisting of the compound [2R, alpha S,2'S,.alpha.'S]-.alpha.,.alpha.'-[iminobismethylene]bis[6-fluo ro-3,4-dihydro-2H-1-benzopyran-2-methanol] or a pharmaceutically acceptable acid addition salt thereof.) to Janssen Pharmaceutica N.V., the patent holder. The Notice withdraws all of the enumerated rejections and confirms such validity. The '040 patent covers nebivolol, the active ingredient in Bystolic(R), a beta-blocker that is currently approved in the United States for the treatment of hypertension. The '040 patent expires in April 2020. Forest has applied for patent term extension for this patent until December 2021.
Earlier in September 2008, USPTO rejected all pending claims of ‘040 patent (as reported earlier by IPPHARMADOC Here)

Budesonide Respules (Pulmicort): Court blocked generic (Teva) and authorized generic (Par)

Teva Pharma announced (Pressrelease) that United States District Court for the District of New Jersey has granted AstraZeneca's request for a temporary order restraining further “at risk” sales of Teva's generic version of AstraZeneca's Pulmicort (Budesonide) Respules® 0.25mg/2mL and 0.5mg/2mL pending the Court's decision on AstraZeneca's motion for a preliminary injunction. As part of the same ruling, AstraZeneca and its partner Par Pharmaceuticals are to suspend distribution of AstraZeneca's own authorized generic.
A preliminary injunction hearing in this matter is scheduled to begin in November 25, 2008 and a trial has been scheduled for January 12, 2009.
Teva's launch was pursuant to USFDA approval (Here) of its generic version of AstraZeneca's Pulmicort (Budesonide) Respules® and the denial of AstraZeneca's Citizen Petition on this product.
As reported earlier by IPPharmadoc in Septemeber (Here), US District Court of New Jersey has denied Teva’s Motion for Summary Judgment
Innovator is in litigation with Ivax (Teva) on following Orange book listed patents:
US4787536 (Expired on: Aug 27, 2006, now not listed in Orange Book): Which covers a dosage package for storing and discharging a liquid, semi-liquid or pasty product, comprising a squeezing thermoplastic container portion and a discharge portion
US6598603 (Expiry: Jun 23, 2019): Which covers a method of treating a patient suffering from a respiratory disease, the method comprising administering to the patient a nebulized dose of a budesonide composition in a continuing regimen at a frequency of not more than once per day.
US6899099 (Expiry: Jun 23, 2019): Which covers a method of treating a patient suffering from a respiratory disease, the method comprising administering to the patient a nebulized dose of a budesonide composition in a continuing regimen at a frequency of not more than once per day, wherein the administration is in the evening.
Innovator is also in litigation with Breath pharma on ‘099 and ‘603 patents.

Drug Approvals

Alprazolam: Apotexl
Fluoxetine Hydrochloride :Mylan Pharma
Fluoxetine Hydrochloride : Sandoz
Midazolam Hydrochloride : Wockhardt
Alfuzosin Hydrochloride Extended-Release Tablets: Aurobindo Pharma (Tentative Approval)
Anastrozole Tablets: Stason Pharma
Banzel (Rufinamide) Tablets: Eisai Medical Research
Diclofenac Sodium Ophthalmic Solution: Apotex
Oxycodone and Acetaminophen Tablets: Coastal Pharmaceuticals, Approval
Venlafaxine Hydrochloride Extended-Release Capsules: Mylan Pharmaceuticals Inc., (Tentative Approval)
Alprazolam Extended-Release Tablets: Apotex Inc.,
Midazolam Hydrochloride Injection: Wockhardt Ltd.

Phenytoin Sodium Extended-Release Capsules: Amneal Pharmaceuticals of NY

Desloratadine: Innovator sued Sun on pharmacokinetic patent

Innovator Schering Corp. sued Sun and Caraco Pharmaceutical Laboratories Ltd. for infringing its latest Clarinex (Desloratadine) patent with intention to block the two drug companies from producing a generic version of the blockbuster allergy treatment.
Innovator sued sun and Caraco for the infringement of following patent:
US7405223 (issued on July 29, 2008; Expiry: Jan 7, 2020): A method of administering a pharmaceutical composition, wherein the method comprises: administering the pharmaceutical composition, comprising desloratadine and a suitable, inert pharmaceutically acceptable carrier or diluent, to target a pharmacokinetic (pK) profile for desloratadine comprising an arithmetic or geometric mean steady state maximum plasma concentration (Cmax) of desloratadine of about 4 ng/mL, and an arithmetic or geometric mean time to maximum plasma concentration (Tmax) of desloratadine of about 3 hours post dose.

Innovator is already in litigation with Ranbaxy, Sun (Caraco), Watson, Dr. Reddy's, Zydus, Sandoz, Mylan, Orchid, Perrigo, Glenmark, GeoPharma and Lupin for this product.

Duloxetine (Cymbalta):Innovator sued four generic players

Innovator Eli Lilly sued Impax, Cobalt, Sandoz Inc. and Wockhardt for infringement of product patent. Following patents are listed for this product in Orange Book:
US5023269 (Expiry: Jun 11, 2013): Which covers 3-aryloxy-3-substituted propanamines capable of inhibiting the uptake of serotonin and norepinephrine
US5508276 (Expiry: Jul 18, 2014): which covers an enteric duloxetine pellet comprising a) a core consisting of duloxetine and a pharmaceutically acceptable excipient; b) an optional separating layer; c) an enteric layer comprising hydroxypropylmethylcellulose acetate succinate (HPMCAS) and a pharmaceutically acceptable excipient; d) an optional finishing layer.
US6596756 (Expiry: Sep 10, 2019): which covers a method of treating fibromyalgia comprising administering to a patient in need of treatment an effective amount of duloxetine.
Innovator sued generic players on ‘269 patent in the United States District Court for the Southern District of Indiana for submission of Abbreviated New Drug Application ("ANDA") for Duloxetine hydrochloride delayed-release capsules (20, 30, and 60 mg), generic of Cymbalta®, to the Food and Drug Administration. The all four generic companies filed ANDA on August 4, 2008, and all filers of ANDAs submitted on that date will be entitled to 180 days of exclusivity under the applicable regulations.

Cymbalta® is a selective serotonin and norepinephrine reuptake inhibitor indicated for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and fibromyalgia. According to Wolters Kluwer Health, U.S. sales of Cymbalta® were approximately $2.3 billion in the 12 months ended September 30, 2008.

Link to other news here
Impax press release Here

Nasacort (Triamcinolone acetonide), Allegra (Fexofenadine) and Allegra D-12 (Fexofenadine and Pseudoephedrine): Barr settled with innovator Sanofi

Barr Pharma (now part of Teva) announced (in a press release here) that it has entered into separate settlement agreements related to ongoing patent challenges for Nasacort (Triamcinolone acetonide) nasal spray, Allegra(R) D-12 Hour (Fexofenadine hydrochloride 60mg and Pseudoephedrine hydrochloride 120mg) extended-release tablets, and Allegra(R) (Fexofenadine) 30mg, 60mg and 180mg tablets. As part of the settlements, the parties have agreed to dismiss the underlying U.S. litigation related to the three patent challenge cases.
"We are very pleased to have reached these three separate settlements, bringing to a close the outstanding patent challenges in a manner that results in the date certain launch of a generic version of Nasacort(R) AQ years prior to the expiration of the applicable patents, and the launch of a generic version of Allegra(R) D-12 in November of 2009," said Bruce L. Downey, Barr's Chairman and CEO. "The agreement related to Allegra(R) resolves any ongoing uncertainty about the possible impact of ongoing litigation for Barr and Teva related to the launch of generic versions of Allegra(R) 30mg, 60mg and 180mg tablets in September 2005. We believe that these agreements represent a pro-consumer resolution to this ongoing litigation."
The individual agreements are subject to review by the Federal Trade Commission (FTC) and state Attorneys General under an outstanding consent decree and settlement entered into by a Sanofi-Aventis predecessor company, and will not become effective for approximately 45 days. The parties may prevent the agreements from becoming effective or terminate the agreements if the FTC or state attorney generals raise objections that cannot be resolved by the parties.
Nasacort Settlement and License Agreement
Barr Laboratories, Inc. has signed a Settlement and License Agreement with Sanofi-Aventis US LLC and Aventis Pharmaceuticals Inc. to resolve the patent litigation involving Barr's Triamcinolone Acetonide nasal spray, the generic versions of Aventis Pharmaceuticals' Nasacort(R) AQ. Under this agreement, Barr will have a license to launch a generic version of Nasacort(R) AQ as early as June 15, 2011 if Barr's ANDA is approved on that date, or earlier in certain circumstances. In addition, even if the Barr's ANDA is not approved, Barr will have a license to launch a generic version of Nasacort(R) AQ, supplied by Sanofi-Aventis, on December 1, 2013, or earlier, in certain circumstances. Upon product launch, Barr would pay Sanofi-Aventis a royalty.
Barr developed its Triamcinolone Acetonide Nasal Spray product with Perrigo Company (NASDAQ: PRGO; TASE) and, under the terms of a separate agreement, will share in the costs and potential benefits with Perrigo.
Allegra(R) D-12 Settlement and License Agreement
Barr Laboratories, Inc. has signed a Settlement and License Agreement with Aventis Pharmaceuticals, Inc. and Albany Molecular Research, Inc. to settle the outstanding patent litigation involving Barr's generic version of Aventis Pharmaceuticals' Allegra(R) D-12 Hour (fexofenadine hydrochloride 60mg and pseudoephedrine hydrochloride 120mg) extended-release tablets. Under the terms of this agreement, Barr is permitted to launch a generic version of Aventis Pharmaceuticals' Allegra(R) D-12 extended-release tablets on November 1, 2009, and Barr has the right to acquire product from Sanofi-Aventis for commercial launch. Upon product launch, Barr would pay Sanofi-Aventis a royalty.
Allegra(R) Tablets Settlement Agreement
Barr Laboratories, Inc. and Teva Pharmaceuticals USA, Inc. have signed an agreement with Aventis Pharmaceuticals, Inc. and Albany Molecular Research, Inc. to settle the outstanding patent litigation involving Barr's and Teva's generic version of Aventis Pharmaceuticals' Allegra(R) (fexofenadine) 30mg, 60mg and 180mg tablets, which Teva launched in September 2005 under a separate agreement with Barr. Under the terms of this agreement, Barr and Teva will each pay Aventis approximately $30 million to settle the patent litigation with Aventis regarding Teva's fexofenadine 30mg, 60mg and 180mg tablets product. In addition, Barr and Teva will pay Aventis a royalty on future U.S. sales.
Earlier, on September 6, 2005, Barr announced that it was working with Teva and has launched this product as a generic "at risk." Sanofi-Aventis countered a week or so later with an authorized generic arrangement with Prasco and is also making attempts to enjoin Barr and speed up the trial process. Barr and Sanofi Aventis were in litigation on polymorph, formulation and method of use patents of Fexofenadine.

Link to related news Here

AMRI press release Here

Emtricitabine and Tenofovir disoproxil fumarate (Truvada): Innovator confirmed reciept of Para IV letter from Teva

Innovator Gilead Sciences announced (in a press release Here) the receipt of a Paragraph IV Certification Notice Letter from Teva Pharmaceuticals on its popular antiviral (HIV) combination . Generic player Teva submitted an Abbreviated New Drug Application (ANDA) to the USFDA requesting permission to manufacture and market a generic version of Truvada(R) (Emtricitabine and Tenofovir disoproxil fumarate; 200 mg +300 mg).
In the Notice Letter, Teva alleges that following two patents associated with Emtricitabine:
US6642245 (Expiry: May 4, 2021): which covers A method for treating HIV infection in humans comprising administering an effective amount of (-)-.beta.-L-2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane, or its physiologically acceptable salt, optionally in a pharmaceutically acceptable carrier.
US6703396 (Expiry: Sep 9, 2021): The (-)-enantiomer of cis-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolane-5-yl)-(1H)-pyrimid in-2-one that is at least 95% free of the corresponding (+)-enantiomer
Patented by Emory University and licensed exclusively to Gilead Sciences are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA submission.
Gilead is currently reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Teva. Such a lawsuit would restrict the FDA from approving Teva's ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first. Truvada is currently protected by 10 patents, which are listed in the FDA's Approved Drugs Products List, and all 10 patents would need to be invalidated or expired before a generic version of Truvada could be marketed. USFDA approved this combination on Aug 2, 2004.

Arimidex (Asnastrozole): Natco Pharma got tentative approval

Natco Pharma has got tentative approval from USFDA to market Anastrozole Tablets (Arimidex , 1mg) . Although, 8 generic players has got tentative approval on this product but generic will only be available after expiry of following Orange Book listed patent:
USRE36617 (Jun 27, 2010): which covers Anastrozole as product
Following generic players has got tentative approval
1.Teva (February 26, 2008)
2.Synthon (May 25, 2007)
3.Roxane (June 28, 2007)
4. Zydus (April 29, 2008)
5. Stason (November 13, 2008)
6. Watson (April 24, 2008)
7. Sandoz (June 25, 2008)
8. Natco (November 7, 2008)
Innovator got approval from USFDA to market Arimidex (Asnastrozole) on Dec 27, 1995.

Pharmaceuticals Export Promotion Council (Pharmexcil) alerted Indian exporter on EU patent law

The Pharmaceuticals Export Promotion Council (Pharmexcil) has alerted industry members about the possible hardships that could occur in view of the EU patent laws which stipulated that any product patent that has been granted in EU countries is liable for confiscation if transported through their countries. (Link to full story from pharmabiz Here)

Drug Approvals reported by USFDA

1) Apriso (Mesalamine) Extended-Release Capsules: Salix Pharma
2) Diethylpropion Hydrochloride Tablets: CorePharma
3) Divalproex Sodium Delayed-Release Tablets: Anchen Pharma
4) Levetiracetam Tablets: Mylan Pharma
5) Treanda (Bendamustine hydrochloride) Injection: Cephalon
6) Amiodarone Hydrochloride Tablets: Apotex Corp
7) Dorzolamide Hydrochloride Ophthalmic Solution: Sandoz Canada
8) Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution: Sandoz
9) Loratadine: Mylan
10) Anastrozole (Arimidex) 1 mg tablet: Natco Pharma (Tentative approval)

Entacapone (Comaton): Innovator sued Sun pharma

Orion Corporation filed a patent infringement lawsuit (press release Here) in the United States to enforce its US5,446,194 (which covers Entacapone as product) against Sun Pharma Global, Inc., who seeks to market a generic version of Orion Corporation's proprietary drug, Comtan® in the United States. Comtan contains Entacapone and is a product originated by Orion Corporation and marketed in the United States for the treatment of Parkinson's disease by its exclusive licensee, Novartis.
As reported earlier by IPPharmadoc Here, Orion Corporation was notified that Sun Pharma Global had submitted an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) that included a Paragraph IV challenge of Orion Corporation's '194 patent. By suing to enforce its patent within 45 days from receipt of the Paragraph IV certification notice, Orion Corporation is entitled to an automatic stay prohibiting the FDA from approving Sun Pharma Global's ANDA for 30 months, or until an earlier court decision adverse to Orion Corporation's patent in the patent infringement lawsuit. As such, the realisation of generic competition is neither certain nor imminent. Orion Corporation and Novartis will vigorously defend the intellectual property rights covering Comtan.

Also, Innovator has already sued first para IV filed Wockhardt for this product

Enrofloxacin: Bayer Sues Norbrook Over Bid to launch generic version

Bayer Healthcare has filed a lawsuit in District Court of Kansas against Norbrook Laboratories Ltd., accusing the veterinary pharmaceutical company of infringing Bayer’s patent for Enrofloxacin as it tries to bring a generic version of the antibacterial drug to market. Innovator in its complaint alleged Infringement of US5756506 (which covers a process for treating a bacterial infection in an animal in need thereof comprising administering to said animal a pharmaceutically effective composition comprising a fluoroquinolone, an ester, or a salt thereof in one high dose, single treatment), following the equivalent of a Paragraph IV certification as part of Norbrook's filing of its ANADA (Abbreviated New Animal Drug Application) to manufacture a generic version of Bayer's BAYTRIL® 100 (Enrofloxacin injection, used for the treatment of bovine respiratory disease in beef and non-lactating dairy cattle).

Lansoprazole (Prevacid) delayed release capsules: Teva's generic version blocked till November, 2009

Teva Pharma announced today (in a press release Here) that the U.S. Court of Appeals for the Federal Circuit has affirmed a March 31, 2008 decision by the District Court, which had found TAP Pharmaceutical Products Inc.'s US4,628,098 valid and enforceable. As a result of today's decision, Teva expects to market its generic version of TAP's Prevacid® (Lansoprazole) Delayed Release Capsules, 15 mg and 30 mg no later than November 10, 2009, when the patent is otherwise set to expire.

Clopidogrel Bisulphate (Plavix): Canadian Supreme court upheld innovator Sanofi’s patent

In a significant decision, the Canadian supreme court has sided with innovator companies on patent evergreening. In a 7-0 judgment today, the Court rejected a request from generic company Apotex to invalidate a competitor's patent for an anti-coagulant drug used to combat cardio-vascular degeneration. Court concluded that innovator took lot of effort to develop New chemical moiety like Clopidogrel. Sanofi spent millions of dollars and even abandoned the project before discovering the compound that led to the development of Plavix.The patent in dispute was challenged by Apotex, which claimed that Sanofi's following patent:

CA1336777(equivalent to US4847265) (Expiry:2012) - Which covers Dextro-rotatory isomer of methyl alpha-5(4,5,6,7-tetrahydro(3,2-c)thieno pyridyl) (2-chlorophenyl)-acetate substantially separated from the levo-rotatory isomer and its pharmaceutically acceptable salts.Is obvious as per earlier expired patent, which covers Clopidogrel genrically .

Apotex attorney said during trial that Sanofi’s scientists used known research methods on a large group of compounds the company had patented earlier to come up with the key ingredient in Clopidogrel as per doctrine of selection. Apotex argued that the doctrine of selection is contradictory to established principles of patent law and urged the court to abolish the practice that allows innovator companies to patent a large group of generic structures and then obtain new patents with enhanced life on individual components that prove useful.

Plavix last year regained its title as the world's second best-selling drug, behind Pfizer Inc.'s Lipitor, with $8.1 billion in global sales.Apotex claims that clopidogrel bisulfate, the active ingredient, was covered by a US4529596 (Expired in 2003). Innovator Sanofi maintains that the earlier patent covered a whole class of generic compounds (Genus) and the discovery of clopidogrel bisulfate was serendipity.Researchers separated the racemic compound into individual enatiomenrs. Sanofi further stressed that resolution of enatiomer resulted into therapeutically active enatiomer.The expert during testimony stressed that abolishing the principle of the doctrine of selection would stifle research and innovation. Supreme court panel announced it would reserve a decision.
The court sided with innovator and concluded that earlier expitred patent covers large group of genus and selection of Clopidogrel was not obvious.
Court concluded that a selection patent that claims a compound that is patentably distinct from the genus patent would not be invalid for obviousness or double patenting. In Clopidogrel case, out of the many compounds (2.5 lakh compounds) predicted to be effective as exhibiting platelet aggregation inhibiting activity in the ‘875 patent, it was found that the dextro-rotatory isomer of the racemate relevant in this case had beneficial properties over both the racemate and the levo-rotatory isomer. Accordingly, the claims in the ‘777 patent reflect a patentably distinct compound from the compounds in the ‘875 patent. As a result, there is no basis for a challenge based on “obviousness” double patenting.
Other news links Here

Court’s decision Here

Drug approvals

1. Adenosine Injection (Akorn Inc)
2. Irinotecan Hydrochloride Injection (Pliva-Lachema)
3. Pamidronate Disodium Injection (Akorn-Strides)
4. Sertraline Hydrochloride Oral Concentrate (Aurobindo Pharma)
5. Toviaz (Fesoterodine fumarate) Tablets (Pfizer Inc.)
6. Amiodarone Hydrochloride Injection (Wockhardt)Risperidone Tablets (Torrent Pharma)

Carbidopa and Levodopa tablets (Sinemet): Caraco and sun launched generic version

Sun Pharma announced (in a press release Here) that USFDA has granted approval for the Abbreviated New Drug Application (ANDA) to market generic Sinemet®, carbidopa and levodopa tablets.
Also, Caraco Pharma, announced that it has launched Carbidopa and Levodopa tablets on behalf of Sun Pharmaceutical Industries Ltd. (Sun Pharma). Carbidopa and Levodopa tablets are used in the treatment of Parkinson's disease and syndrome. These generic versions of Carbidopa and Levodopa 10 mg / 100 mg, 25 mg / 100 mg, and 25 mg / 250 mg tablets are bioequivalent to Sinemet® tablets distributed by Bristol-Myers Squibb. According to IMS Data, these strengths of Carbidopa and Levodopa had US. Sales of approximately $70 million for the 12-month period ended June 2008.

Perindopril tablets: Glenmark Generics launched its first product in EU market

Glenmark Generics Limited has announced that its EU subsidiary has launched its first product in United Kingdom with the launch of Perindopril tablets (2,4, 8 mg/tablet) in the United Kingdom Here

Omeprazole/Sodium bicarbonate Capsules and Powder for Oral Suspension: Innovator Santarus announced favorable Marksman hearing against Par Pharma

Santarus, Inc. (Santrus press release Here), a specialty pharmaceutical company, today announced that Chief Judge Gregory M. Sleet of the U.S. District Court for the District of Delaware has ruled in favor of Santarus and the University of Missouri following the Markman hearing held November 5, 2008. "Markman" hearings, also known as claim construction hearings, are held to resolve any disputes concerning the meaning of asserted patent claims prior to trial. Par Pharmaceutical, Inc. had disputed the meaning of some but not all of the patent claims asserted by Santarus as part of the lawsuits Santarus filed against Par in the Delaware District Court for infringement of patents listed in the Orange Book for ZEGERID(R) (Omeprazole/Sodium bicarbonate) Capsules and Powder for Oral Suspension. The University of Missouri, licensor of the patents, is joined in the litigation as co-plaintiff.
During the hearing, held in Wilmington, Delaware, both sides presented arguments. Shortly following the hearing, Chief Judge Sleet issued an order consistent with the positions asserted by plaintiffs Santarus and the University of Missouri.
"We are very pleased with the outcome of the hearing and are focused on continuing to enforce and defend the intellectual property protecting our ZEGERID products," said Gerald T. Proehl, president and chief executive officer of Santarus.
Santarus and the University of Missouri are asserting infringement by Par of five issued patents covering ZEGERID Capsules and Powder for Oral Suspension because of Par's intent to market generic versions of Santarus' ZEGERID products prior to the July 2016 expiration of the asserted patents. The trial is currently scheduled for July 2009.
Santarus has full confidence in and is prepared to vigorously defend and enforce the intellectual property protecting its ZEGERID products.

Levetiracetam (Keppra): Mylan launched tablets in US market with generic exclusivity

Mylan has received final approval on Nov 4, 2008 from the USFDA for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 250 mg, 500 mg and 750 mg. Levetiracetam Tablets are the generic version of UCB Pharma's Keppra®.
Robert J. Coury, Mylan's Vice Chairman and CEO, commented: "We are extremely pleased to be able to monetize another first-to-file opportunity and to offer a more affordable alternative for patients. In addition, after our very strong performance in the third quarter, the launch of Levetiracetam is another significant step toward the continued execution on our stated goals for 2009 and beyond." Following patent is listed for Levetiracetam in the Orange Book:
US4943639 (Expiry: Jan 14, 2009): Which covers Levetiracetam as product.
Mylan and UCB Societe Anonyme and UCB Pharma Inc. (collectively, UCB) previously had entered into an agreement to settle pending litigation relating to Levetiracetam Tablets. Pursuant to the settlement, Mylan was given the right to market the 250 mg, 500 mg and 750 mg strengths of Levetiracetam Tablets in the United States as early as Nov. 1, 2008, provided that UCB obtained pediatric exclusivity for Keppra and Mylan's ANDA obtained final approval from the FDA. UCB was granted pediatric exclusivity relating to the '639 patent, which extends to Jan. 14, 2009. Additional terms of the settlement are confidential.
Levetiracetam Tablets had U.S. sales of approximately $1 billion for the 12 months ending Sept. 30, 2008, for these three strengths.
Levitiracetam was approved by USFDA on Nov 30, 1999 for 250 mg, 500 mg and 750 mg strength tablets. However, 1g tablet strength was approved by USFDA on Jan 6, 2006

Mylan's press release Here

Boniva (Ibandronate sodium) 150 mg tablets: Innovator sued Orchid for infringement of method of use patent

Innovator Hoffman La Roche filed a third lawsuit in a US court to block an ANDA application by Orchid Chemicals and Pharmaceutical Ltd. seeking marketing approval for a generic version of Boniva (Ibandronate sodium) in 150 mg strength, Roche’s best-selling prescription drug for osteoporosis.
Following patents are listed in Orange Book for this product
US4927814 (Expiry: Mar 17, 2012): Covers Ibandronate sodium as product
US6143326 (Expiry: Apr 21, 2017): Covers method of treating a bone disease in a patient in need thereof, comprising orally administering to the patient a pharmaceutical formulation comprising a tablet core containing about 0.1 to 100 mg of ibandronate and a coating which is free of ibandronate and has the following proportional composition: (a) about 51.425% by weight of methylhydroxypropylcellulose; (b) about 24.650% by weight of titanium dioxide; (c) about 15.000% by weight of polyethylene glycol; and (d) about 8.925% by weight of talc.
US6294196 (Expiry: Oct 7, 2019): A pharmaceutical composition in solid unit dosage form, said dosage form comprising an inner phase containing as the active substance ibandronic acid, or a physiologically compatible salt or hydrate thereof, said active substance being present in the dosage form in an amount of from about 0.2% to 30% by weight of the dosage form, and an outer phase containing stearic acid in an amount of about less than 5% by weight of the dosage form, wherein said inner phase comprises about at least 80% by weight of the dosage form and said outer phase comprises from about. 0.1% to 20% by weight of the dosage form.
US7410957 (Expiry: May 6, 2023): A method for treating osteoporosis comprising commencing treatment by orally administering to a subject in need of such treatment, on a single day, a first dose in the form of a tablet, wherein said tablet comprises an amount of a pharmaceutically acceptable salt of ibandronic acid that is equivalent to about 150 mg of ibandronic acid and continuing said treatment by orally administering, once monthly on a single day, a tablet comprising an amount of a pharmaceutically acceptable salt of ibandronic acid that is equivalent to about 150 mg of ibandronic acid.
The new lawsuit, filed in the district court of New Jersey, claims that Orchid product will infringe recently issued patent '957.

Teva (and Gate), Mutual Pharmaceuticals, Apotex, Dr. Reddy's, Cobalt, Genpharm, Actavis and Orchid are the generic players currently in litigation with innovator.
USFDA has approved two strengths of innovator Hoffman La Roche for Boniva (Ibandronate sodium) 2.5 mg base (approved on May 16, 2003) and 150 mg base (approved on Mar 24, 2005)
Link to livemint news Here

Stalevo (Carbidopa; Entacapone; Levodopa): Wockhardt filed Para IV

Indian Pharma company Wockhardt has challenged the US patent of Stalevo (CARBIDOPA; ENTACAPONE; LEVODOPA) a new generation combination drug for the treatment of Parkinson's disease, originated by Finland-based Orion Corporation and marketed by Novartis.
Wockhardt has filed an abbreviated new drug-marketing application (ANDA) with the USFDA, seeking authorisation to produce and market a generic version of Stalevo in 12.5, 200 and 50 mg strengths, announced Orion Corporation.
Orion, together with Novartis, is currently evaluating legal options to protect its rights, and at this point. The ANDA review process is just beginning and the realisation of generic competition is neither certain, nor imminent.
In early January this year, another Indian drug major, Sun Pharmaceutical Industries, had challenged three patents of Stalevo. The latest of Stalevo's six US patents are to expire by October 31, 2010. The drug was given marketing permission by the FDA in June 2003. Following patents are listed in orange book for this product
US4963590 (Expiry: Nov 27, 2007): Claims Pharmaceutical composition and method of use of catechol-O-methyl transferase inhibitor

US5112861 (Expiry: May 12, 2009): Method of use with Entacapone and levodopa

US5135950 (Expiry: Oct 31, 2010): Crystallographically essentially pure polymorphic form A

US5446194 (Expiry: Oct 19, 2013): Covers Entacapone as product

US6500867(Expiry: Jun 29, 2020): Covers An oral solid tablet composition comprising pharmacologically effective amounts of Entacapone, Levodopa, and Carbidopa, or pharmaceutically acceptable salts or hydrates thereof, and a pharmaceutically acceptable excipient, wherein a substantial portion of carbidopa or a pharmaceutically acceptable salt or hydrate thereof is separated from entacapone and levodopa or pharmaceutically acceptable salts or hydrates thereof in the tablet.
US6797732 (Expiry: Jun 29, 2020): A stable oral solid composition comprising pharmacologically effective amounts of active agents consisting of Entacapone, Levodopa, and Carbidopa, or pharmaceutically acceptable salts or hydrates thereof, and comprising at least one pharmaceutically acceptable excipient other than microcrystalline cellulose
Wockhardt's Has challenged innovator’s ‘950, ‘194, ‘867 and ‘732 patents listed in the Orange Book.
Entacapone is a catechol-O-methyl transferase inhibitor for the treatment of Parkinson's disease. When administered in conjunction with dopaminergic agents such as L-DOPA, Entacapone increases the bioavailability of these compounds by facilitating their passage across the blood-brain barrier.
Importantly, Wockhardt is first Para IV filer on Entacapone tablets (Comtan) and innovator Orion sued Wockhardt for in the District Court of Delaware. The case is pending in the Delaware district court, US, and may come up for hearing in November 2009. Sun Pharma also had challenged the patent on Comtan's 200 mg version.
USFDA approved Stalevo (CARBIDOPA; ENTACAPONE; LEVODOPA) NDA for 12.5MG;200MG;50MG, 25MG;200MG;100MG and 37.5MG;200MG;150MG strength on Jun 11, 2003.
Recently, USFDA approved new strengths of Stalevo (CARBIDOPA; ENTACAPONE; LEVODOPA) 50MG;200MG;200MG (approved on Aug 2, 2007), 18.75MG;200MG;75MG (approved on Aug 29, 2008), and 31.25MG;200MG;125MG (approved on Aug 29, 2008)
Earlier news of ip pharmadoc on this product Here

Link to Business standard News

New Paragraph IV filings reported by USFDA in October 2008

1) Cyclobenzaprine (Amrix) Extended-release Capsule 15 mg and 30 mg (Para IV filing date: Aug 11, 2008)
2) Sevelamer (Renagel) Tablets 400 mg and 800 mg (Para IV filing date: May 22, 2008)
3) Sumatriptan and Naproxen (Treximet) Tablets 85 mg/500 mg (Para IV filing date: July 23,2008)
4) Paricalcitol (Zemplar) Capsules 4 mcg (Para IV filing date: Aug 25, 2008)
5) Oxybutynin (Oxytrol) Transdermal System Extended-release 3.9 mg/24 hrs (Para IV filing date: Aug 19, 2008)
6) Clozapine (Fazaclo) Orally Disintegrating Tablets 12.5 mg (Para IV filing date: June 5, 2008)
7) Amlodipine and Olmesartan (Azor) Tablets 10 mg/20 mg and 5 mg/40 mg (Para IV filing date: March 31, 2008)

Risperidone tablets: Zydus sued Teva after the latter asked for process details of API

Indian pharma giant Zydus Cadila, has taken Teva pharma, the big daddy of generic business, to court in the USA, seeking damages for Teva's antitrust violations and unfair trade practices relating to antipsychotic Risperidone.
Teva had gained exclusivity over Risperdal (Risperidone), branded by Johnson &Johnson, in June 2008, which was later withdrawn by USFDA after court's decision on Sep 14, 2008 (as reported earlier by this blog), Teva almost enjoyed 90 days exclusivity on this product before the court's decision. Zydus Cadila received the USFDA' s final approval to market multiple strengths of generic Risperidone on October 19, 2008. According to the patent petition filed on October 14 by Zydus Cadila, Teva, through a letter dated September 15, 2008, demanded that Zydus should refrain from marketing any Risperidone products until Teva could complete an analysis of Zydus's abbreviated new drug application (ANDA) and review the processes by which such products would be made. The Confidential Disclosure Agreement (CDA) attached to the demand letter requires that Zydus stipulate and agree that Teva's counsel not be disqualified from representing Teva with respect to the prosecution of the pending patent. Zydus has denied any infringement of Teva's patent claims and alleged that Teva obtained the following US Patents wrongfully with the intent to deceive the USPTO.

US6750341 (Teva) : Covers novel forms of risperidone, designated Form A, Form B and Form E. Methods for their preparation are also disclosed. The present invention also relates to processes for making risperidone. Pharmaceutical compositions containing the new forms of risperidone and methods of using them are also disclosed.

US7256195 (Teva): which covers a solid or solid-containing pharmaceutical formulation comprising a crystalline form of risperidone with a pharmaceutically acceptable carrier and/or a pharmaceutically acceptable excipient, wherein the crystalline form of risperidone is characterized by x-ray powder diffraction peaks at 14.0.+-.0.2 and 21.7.+-.0.2 degrees two-theta.

In its filing, Zydus also said that Teva's representatives have been allegedly advising Zydus's customers that a legal action by Teva against Zydus would result in unsellable stock, should they purchase API or any formulation using API from Zydus. Teva is also allegedly threatening both Zydus and its customers with legal action to curtail any distribution of Zydus Risperidone API and API formulation (Source: Link to Economic times news)

IPPharmadoc believes that the above startegy adopted by Teva to threaten generic players by citing its polymorph patents, is to stop further generic challenge after USFDA declined Teva's 180 days exclusivity on Risperidone. The estimated sale targets set by Teva will not be achieved and the Teva will face further generic challenge with approval of other generic players ANDA.

Generic players

Till now, Teva, Mylan, Dr. Reddy, Pliva, Apotex, Zydus, Aurobindo, Wockhardt and Torrent had got final approval to market this product. Around 10-15 generic players are ready to enter into the US market on this product.
Eralier news of IPPharmadoc on Risperidone Here

Patent office hits Titan Pharmaceuticals with a setback

The USPTO turned down the company’s claims in a method of use patent application for Probuphine Link to BizJournals news Here

Court Of Appeal for Federal Circuit (CAFC) declined business model patents

In a significant decision today, CAFC in hearing en banc decision thwarted attempt to patent business model patents, a request by applicant Bilski et al. In the hearing en banc decision 3 judges (Judge Newman, Radar, Mayer) opposed the decison.

The court upheld Board of Patent Appeals (BPAI) decision that Bilski et al’s claimed invention (a method of hedging risks in commodities trading) does not satisfy the patentable subject matter requirementsas per 35 U.S.C. § 101.

Court also concluded that a claimed process is patentable under § 101 if:

(A) it is tied to a particular machine or apparatus, or

(B) it transforms a particular article into a different state or thing.

(As per earlier ruling of supreme court)

Court concluded that claimed invention In Re Bilski fails in above tests, hence, not patantable

Opinion of court

Impact on Indian industry

Although, the above decision was hailed by many software companies in US but in India, which is a major outsourcing hub for IT related work, the companies are not happy with the court's decision. Economic times has reviewed the impact of this decision on Indian IT industry Here

Dorzolamide Hydrochloride-Timolol Maleate (COSOPT and TRUSOPT): Prasco ready to launch generic form, Hi-Tech Pharma lose 180 days exclusivity

Prasco has begun shipping generic forms of Dorzolamide Hydrochloride-Timolol Maleate and Dorzolamide Hydrochloride Ophthalmic Solutions, comparable to Merck’s COSOPT® and TRUSOPT®.
Trusopt (Dorzolamide hydrochloride ophthalmic solution) is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Trusopt is used to lower increased intraocular pressure in open-angle glaucoma and ocular hypertension.
Cosopt (Dorzolamide hydrochloride & Timolol maleate) is a drug for lowering pressure in the eye to normal levels, and a treatment for glaucoma.
(Source: Prasco press release)
Also, Hitech and apotex has got final approval to market on October 28, 2008.
Cosopt 180 days exclusivity
The USFDA has denied Hitech pharma 180 days exclusivity for Cosopt (Dorzolamide hydrochloride & Timolol maleate) FDA law blog has reviewed the Hitech’s forfeiture of 180 days exclusivity due to failure to market in details Here
Earlier news of IPPharmadoc on this litigation here

Vfend 50 mg and 200 mgTablets (Voriconazole):Matrix won 180 days exclusivity without any opposition from innovator Pfizer, Matrix can file DJ action

Mylan today announced that its Indian subsidiary Matrix Lab has challenged Pfizer Inc.'s patents for its Vfend Tablets (Voriconazole: (2R,3S)-2-(2,4-difluorophenyl)-3- (5-fluoropyrimidin-4-yl)-1- (1H-1,2,4-triazol-1-yl) butan-2- ol), 50 mg and 200 mg, with the filing of its Abbreviated New Drug Application (ANDA). Importantly, Pfizer did not file a lawsuit against Matrix within the 45-day time period provided by the Hatch-Waxman Act to initiate an automatic stay of regulatory approval. Consequently, Matrix's ANDA will be eligible for final approval as soon as regulatory review by USFDA is complete.
US5116844 (Expiry: Aug 11, 2009): Link (Covers composition)
US5364938 (Expiry: Nov 15, 2011): Link (Covers Voriconazole generically)
US5567817 (Expiry: May 24, 2016): Link (Covers Voriconazole specifically)
US5773443 (Expiry: Jan 25, 2011): Link (Covers Voriconazole generically)
Matrix submitted its ANDA on April 14, 2008, and believes it is the first company to submit a substantially complete ANDA containing a Paragraph IV certification, and will be entitled for 180 days generic exclusivity.
Vfend Tablets, a triazole antifungal agent was approved by USFDA on May 24, 2002, had annual U.S. sales of approximately $157 million for the 12 months ending June 30, 2008, for the noted strengths, according to IMS Health.
Currently, Mylan has 112 ANDAs pending FDA approval, 23 of which are potential first-to-file opportunities.
Ippharmadoc believes that Mylan will now file Declaratory Judgment (DJ) against the listed patents. (Biomedicine news Link)

Clarithromycin Extended Release Tablets: CAFC Upholds Preliminary Injunction

Court of appeal for federal circuit court ruled that Sandoz could not start marketing its generic version of Clarithromycin Extended Release Tablets before the resolution of the patent trial with innovator Abbot.
The dispute was on preliminary injunction granted by district court in favor of innovator Abbot. preliminary injunction in equity, is an injunction entered by a court prior to a determination of the merits of a legal case, in order to restrain a party from going forward with a course of conduct until the case has been decided. If the case is decided against the party that has been enjoined, then the injunction will usually be made permanent. If the case is decided in favor of the party that has been enjoined, the injunction will usually be dissolved or dismissed. In most courts in the United States, the party seeking the preliminary injunction must demonstrate all four things together:
1) That there is a substantial likelihood of success on the merits of the case,
2) That they face a substantial threat of irreparable damage or injury if the injunction is not granted,
3) That the balance of harms weighs in favor of the party seeking the preliminary injunction
4) That the grant of an injunction would disserve the public interest. (Source: wikipedia)
The dispute was w.r.t factor 1 of preliminary injunction i.e substantial likelihood of success on the merits of the case. While the defendant (Sandoz) did raise a substantial question of the vulnerability of the patent, it did not provide any clear and convincing evidence of invalidity.
The presentation of sufficient evidence to show the likelihood of prevailing on the merits is quite different from the presentation of substantial evidence to show vulnerability
It is pertinent to mention here that obviousness grounds based on 3 prior art documents provided by Sandoz were sound and based on this one judge was against preliminary injunction. IPPharmdoc believe that there are chances of hearing en banc on the said issue.

Opinion of court

Para IV filings: Mylan (Cyclobenzaprine Hydrochloride ER Capsules), Barr (oxymorphone hydrochloride ER tablets) and Par (Sumatriptan/Naproxen)

Mylan (Cyclobenzaprine Hydrochloride ER Capsules)
Innovator Cephalon and Eurand has confirmed the receipt of a Paragraph IV Certification Notice Letter on October 20, 2008 regarding an Abbreviated New Drug Application (ANDA) submitted to the USFDA by Mylan Pharma, requesting approval to market and sell a generic version of the 15 mg and 30 mg strengths of AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Capsules).

Barr (oxymorphone hydrochloride ER tablets)
Barr Pharma confirmed that it has initiated a challenge of the patents listed by Endo Pharmaceuticals Inc. in connection with its Opana(R) ER (Oxymorphone hydrochloride) extended-release tablets, 5 mg, 10 mg, 20 mg and 40 mg.

Par (Sumatriptan 85 mg/Naproxen sodium 500 mg tablets)
Innovator Pozen and GlaxoSmithKline (GSK) has confirmed that they received a Para IV letter from Par Pharma on Treximet (Sumatriptan 85 mg/Naproxen sodium 500 mg). Par's letter advised POZEN and GSK that it intended to market a generic version of Treximet tablets before the expiration of following Orange Book listed patents, with following starategy:
US5037845: (Expiry: Aug 6, 2008)- Para III
US6060499 (Expiry: Aug 14, 2017)- Para IV
US6586458 (Expiry: Aug 14, 2017)- Para IV
US7332183. (Expiry: Oct 2, 2025)- Para IV
Earlier, innovator got approval on this combination on Apr 15, 2008. The New combination exclusivity on this product will expire on Apr 15, 2011.

Ciprofloxacin: The US court approved settlement between generic and innovator to be lawful

The U.S. Court of Appeals for the Federal Circuit (CAFC) has upheld the 2005 decision of the U.S. District Court of New York, which rejected a challenge to the lawfulness of a 1997 patent litigation settlement between Barr Labs and The Rugby Group (which has since been acquired by Watson Pharmaceuticals). and Bayer Corporation related to the antibiotic Ciprofloxacin. CAFC affirmed the grant of summary judgment by the District Court and concluded that Agreements were not in violation of section 1 of the Sherman Act because any anti-competitive effects caused by the Agreements were within the exclusionary zone of the patent. The CAFC affirmed the court's dismissal of antitrust claims.
(Opinion of the court here)
Earlier news of IPPharmdoc on Ciprofloxacin antitrust issues Here

Entacapone (200mg) Tablets: Sun Pharma filed Para IV

Orion Corporation has confirmed that it has received Paragraph IV certification from SunPharma against Orange book listed patents for Comtan (Entacapone, 200mg tablets). USFDA approved this product on Oct 19, 1999. Patentee Orion Pharma has licensed this molecule to Novartis. Orion previously sued Sun Pharmaceutical Industries Ltd. for patent infringement when it challenged certain Orion U.S. patents as part of an earlier filed ANDA on a generic version of Orion's proprietary drug, Stalevo as reported earlier by IPPharmadoc Here . That action is pending in the District Court for the District of New Jersey.
US4963590 (Expiry: Nov 27, 2007): Claims Pharmaceutical composition and method of use of catechol-O-methyl transferase inhibitor
US5112861 (Expiry: May 12, 2009): Method of use with Entacapone and levodopa
US5135950 (Expiry: Oct 31, 2010): Crystallographically essentially pure polymorphic form A
US5446194 (Expiry: Oct 19, 2013): Covers Entacapone as product
US6599530 (Expiry: Sep 14, 2018): Covers an oral compacted composition in the form of a tablet, which comprises a pharmaceutically effective amount of entacapone, nitecapone, or pharmaceutically acceptable salt of entacapone or nitecapone, and croscarmellose sodium in an amount of at least 6% by weight of the composition.
Entacapone is a catechol-O-methyl transferase inhibitor for the treatment of Parkinson's disease. When administered in conjunction with dopaminergic agents such as L-DOPA, entacapone increases the bioavailability of these compounds by facilitating their passage across the blood-brain barrierFurthermore, Wockhardt is first Para IV filer on this product and innovator Orion sued Wockhardt for in the District Court of Delaware. Sun Pharma has challenged product patent ‘194 and formulation patent ‘530. Also, Sun has not challenged method of use patent ‘861 and crystalline polymorph patent ‘950. From this filing, it can be concluded that Sun pharma intend to enter into the market after the expiry of ‘950 patent on Oct 31, 2010

Generic Approvals: US market

Final approval
Primidone Tablets: Dr. Reddy's Laboratories
Bromocriptine Mesylate Tablets: Paddock Lab
Galantamine Hydrobromide Extended-release Capsules: Barr Lab
Cyclobenzaprine Hydrochloride Tablets: Aurobindo
Promethazine Hydrochloride Injection: Wockhardt USA
Tramadol Hydrochloride and Acetaminophen Tablets: Alphapharm

Tentative Approval
Arsenic Trioxide Injection: Teva Parenteral
Olmesartan Medoxomil and Hydrochlorothiazide Tablets: Mylan Pharmaceuticals
(Source:USFDA)

Canadesartan+Hydrochlorthiazide: Paragraph IV filed

A generic company has filed Paragraph IV against Atacand HCT® (Candesartan and Hydrochlorothiazide) Tablets 16 mg/12.5mg and 32mg/12.5mg on June 25, 2008. The said combination was approved by USFDA on Sep 5, 2000 . Also, innovator got approval on another combination 32mg ;25 mg on May 16, 2008.

Following Orange Book patents are listed for this product:

US5705517 (Expiry: Apr 18, 2011): Covers candesartan as product
US5196444 (Expiry: Jun 4, 2012): Which covers A stable crystal of 1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)-biphenyl-4-yl]methyl]benzimidazole-7-ca rboxylate.
US5534534 (Expiry: Jul 9, 2013): A pharmaceutical composition of Candesartan
US5721263 (Expiry: Feb 24, 2015): Covers a pharmaceutical composition, which comprises (.+-.)-1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7 -carboxylate or a pharmaceutically acceptable salt thereof in combination with hydrochlorothiazide (or diuretic)
US5958961 (Expiry: Jun 6, 2014): Covers pharmaceutical combination
Earlier, the monotherapy of Atacand received a Para IV filing back in 2006 from generic player Sandoz. The generic player filed its Para IV against polymorph and formulation patents and Paragraph III against product patent. Importantly, innovator did not sued the generic player.

Riluzole 50 mg tablet (Rilutek): CAFC favored innovator sanofi Aventis, generic launch after expiry of product patent

CAFC favored innovator Sanofi Aventis in a patent dispute on generic form of Riluzole by Impax. Following is the only orange book listed patent for Riluzole:
US5527814 (Expiry: Jun 18, 2013): Which covers Riluzole as product
Impax tried to prove invalidation on the grounds that ‘814 patent is anticipated and obvious in light of prior art disclosure.
Also, Impax tried to prove inequitable conduct. However, CAFC upheld District court’s decision that selection of Riluzole is not anticipated by the prior art (Aventis’s patent US5236940). Court found that ‘940 patent although discloses Riluzole as a Markush structure, but do not discloses its effectiveness in treating RLS. Furthermore, court concluded that
Opinion

Clopidogrel Besylate: German Court ruled in favor of Generic companies

The Acino Group has won favorable German court ruling in the legal proceedings regarding Clopidogrel Besylate. In a significant decision by the German High Court (Oberverwaltungsgericht) Nordrhein-Westfalen, dismissed the objections against the immediate enforcement of the drug approval for clopidogrel, developed by Acino. The initial drug approval therefore remains in effect and the generic clopidogrel Besylate by Ratiopharm and Hexal for 75 mg tablets, which were launched in July 2008, will remain in the market. The generic oproduct is 25% Cheap in comparison to innovator product Clopidogrel Bisulfate.
Also, Swiss generics maker Schweizerhall had earlier received German approval for clopidogrel Besylate (Sanofi's aproved form is Clopidogrel bisulfate in May. Sandoz (generic unit of Novartis) was set to market generic Plavix in Germany as per their agreement with Schweizerhall
Earlier, In a significant ruling favoring generic palyers in July, 2008 ,a German court has allowed generic launch of Clopidogrel besylate. the German Administrative Court in Cologne (Verwaltungsgericht Köln) had ordered the immediate execution of the product approval granted by the BfArM (Federal Institute for Drugs and Medical Devices, ). This ruling led Cimex AG, Schweizerhall and Novartis to launch this product in Germany and subsequently into the European market. Innovator Sanofi-Aventis and its U.S. partner Bristol-Myers Squibb announced that they would challenge a German court's decision to immediately authorize marketing of the generic versions of their blockbuster blood thinner Plavix (Clopidogrel). This was later challenged by innovator Sanofi-Aventis und Bristol-Myers Squibb. Afterwards, Sanofi-Aventis appealed to the German Higher Administrative Court Nordrhein-Westfalen against the ruling issued by the Administrative Courtin Cologne requesting a temporary suspension of the drug approval. However, the Higher Administrative Court Nordrhein-Westfalen dismissed this appeal on August 1, 2008. The latest decision of the Administrative Court Nordrhein-Westfalen regarding these preliminary legal proceedings can not be challenged by ordinary appeal.

Importantly, the above decision will increase chances of subsequent generic approval in other major European countries.

Clopidogrel was first disclosed in EP99802, which covers Clopidogrel racemic form generically. The said patent has expired in 2003 in most European countries. The innovator's patent EP281459, claims enatiomeric form of Clopidogrel sulfate as product and will expire on 15 Feb, 2013 (with SPC) in most European countries. The innovator has claimed various salts of Clopidogrel like hydrochloride, hrdrobromide, taurocholate and bisulfate form. generic companies designed around against the said patent by developing Besylate salt, not covered in the '459 patent.

Acino press release: Here
Earlier news of IPPharmadoc on this product Here