Friday, 28 November, 2008

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

Thursday, 27 November, 2008

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 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.

Wednesday, 26 November, 2008

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)

Tuesday, 25 November, 2008

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)

Monday, 24 November, 2008

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.

Friday, 21 November, 2008

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

Thursday, 20 November, 2008

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

Monday, 17 November, 2008

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)

Friday, 14 November, 2008

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

Monday, 10 November, 2008

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.

Wednesday, 5 November, 2008

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

Monday, 3 November, 2008

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)

Saturday, 1 November, 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

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
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