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