Synthon sued for generic tadalafil and believes to be "FTF" for 180 days exclusivity

Synthon has been sued by Eli Lilly and Icos Corporation in connection with the filing of Synthon's ANDA for Tadalafil 20 mg. Synthon's Tadalafil 20 mg Tablets product is a generic and bioequivalent version of Lilly's and United Therapeutics’ Adcirca® tablets which is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability. Synthon believes that it is the ’Single First Filer’ of an ANDA with a Paragraph IV certification for the Adcirca® (Tadalafil) tablets, 20 mg. As a result, Synthon expects to be eligible for 180 days of Hatch-Waxman exclusivity upon the first commercial marketing of their generic drug product.

Teva sends ANDA certificate notification to Gilead Sciences for Viread

Gilead Sciences announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an ANDA to the USFDA requesting permission to manufacture and market a generic version of Viread^® (tenofovir disoproxil fumarate). In the notice letter, Teva alleges that three patents associated with tenofovir disoproxil – US Patent Numbers 5,922,695; 5,977,089; and 6,043,230; and one patent associated with tenofovir disoproxil fumarate – US Patent Number 5,935,946 – owned by 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. Viread is currently protected by four patents, which are listed in the FDA's Approved Drug Products List, and all four patents would need to be invalidated or expired before a generic version of Viread could be marketed. The USPTO confirmed the patentability of these four Viread patents in 2008.

Gilead currently has a lawsuit pending against Teva in response to Teva's attempts to seek approval for generic versions of Truvada^® (emtricitabine and tenofovir disoproxil fumarate) and Atripla^® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) based on allegations that two emtricitabine patents are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of its generic product.

Impax confirms Patent Challenge against Colesevelam HCl tablets, 625 mg

Impax has initiated a challenge against patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL® (Colesevelam HCl) tablets, 625 mg by filing an ANDA containing a para IV certification for a generic version of WELCHOL® with the USFDA. Following receipt of the notice from the FDA that Impax's ANDA had been accepted for filing, Impax notified the NDA holder and patent owners of its paragraph IV certification. On January 14, 2010, Daiichi Sankyo, Inc. and Genzyme Corporation filed suit for patent infringement against Impax in the United States District Court for the District of Delaware. This action formally initiates the patent challenge process under the Hatch-Waxman Act. Based on the filing date of the ANDA, the Company believes that it is the first to file an ANDA with a paragraph IV certification and expects to be entitled to 180 days of market exclusivity. Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax's generic division, will commercialize the products.

WELCHOL® is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin), reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia as monotherapy or in combination with a statin after failing an adequate trial of diet therapy, and improve glycemic control in adults with type 2 diabetes mellitus. According to Wolters Kluwer Health, U.S. sales of WELCHOL® were approximately $308 million for the twelve-month period ending November 2009.

Cephalon files an infringement suit on Teva for NUVIGIL® (armodafinil) Tablets

Cephalon, Inc. it has filed a lawsuit in U.S. District Court in Delaware against Teva Pharmaceuticals USA, Inc. for infringement of U.S. Patent Nos. 7,132,570 (the "'570 Patent"), 7,297,346 (the "'346 Patent") and RE37,516 (the "'516 Patent") for the Cephalon product NUVIGIL® (armodafinil) Tablets [C-IV]. Cephalon has a three-year period of marketing exclusivity for NUVIGIL that extends until June 15, 2010. In addition, including the six-month pediatric extension, the '516 Patent, the '346 Patent, and the '570 Patent expire on April 6, 2015, May 29, 2024, and June 18, 2024, respectively.

Teva did not challenge Orange Book-listed U.S. Patent No. 4,927,855 (the "'855 Patent"), which provides additional protection until October 22, 2010, the expiration date of the '855 Patent. The lawsuit is based upon an Abbreviated New Drug Application (ANDA) filed by Teva seeking FDA approval for a generic equivalent of armodafinil to be sold in the United States. Teva alleges that the above NUVIGIL patents are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA.

Warner files lawsuit for Infringement of Doryx (US 6,958,161) Patent

Warner and one of its subsidiaries and "Mayne", a subsidiary of Hospira Inc. have filed a lawsuit against Sandoz Inc. in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 (the "'161 Patent") which covers DORYX, a tetracycline-class oral antibiotic.

Warner markets and sells DORYX DR tablets in 150, 100 and 75 mg strengths under a license agreement with Mayne. Warner Chilcott previously announced the filing of similar lawsuits against each of Mutual Pharmaceutical Company, Inc., Mylan Pharmaceuticals Inc. and Impax Laboratories, Inc. on December 23, 2008. The lawsuit is in response to the submission of an ANDA) to the USFDA by Sandoz requesting approval to manufacture and sell generic versions of DORYX 100 and 75 mg DR tablets prior to the expiration in 2022 of the '161 Patent. Warner Chilcott and Mayne intend to vigorously defend the '161 Patent and pursue their legal rights.

Pfizer sues Apotex for infringement of '995 patent

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.

For a detailed action filed by Pfizer, click here

Watson Receives FDA Approval for Generic Razadyne ER Capsules

Watson has received approval from the USFDA on its ANDA for galantamine hydrobromide ER capsules, eq. to 8 mg, 16 mg and 24 mg (galantamine base). Galantamine hydrobromide extended-release capsules are the generic equivalent to Ortho McNeil Janssen's Razadyne(R) ER, galantamine HBr extended-release capsules, which are indicated for the treatment of Alzheimer's disease.

Watson intends to launch the product immediately. Razadyne(R) ER had annual sales of approximately $112 million for the twelve months ending September 2008, according to IMS sales data.

USFDA grants tentative approval to MDRNA's generic calcitonin-salmon nasal spray

The USFDA has granted tentative approval to MDRNA's ANDA for generic calcitonin-salmon nasal spray for the treatment of osteoporosis. Full FDA approval would follow the completion of Apotex's 180-day exclusivity period, or June 2009.

MDRNA's generic calcitonin-salmon nasal spray is the generic equivalent of Miacalcin marketed by Novartis Pharmaceuticals Corporation. US sales of Miacalcin were approximately $147 million in 2007. On December 23, 2003, FDA accepted for filing MDRNA's 505(j) paragraph 4 ANDA for the product. In October 2004, MDRNA and Par Pharmaceutical Companies, Inc. entered into an exclusive license and supply agreement for US distribution and marketing of the product. Under terms of the agreement, MDRNA is responsible for obtaining regulatory approval and manufacturing, and will receive product transfer payments for manufactured product and profit sharing following commercialization.

Lupin settles desloratadine lawsuit with Schering-Plough

Lupin Ltd has announced that the company has settled all ongoing Hatch-Waxman litigation relating to desloratadine tablets, the generic version of Schering-Plough's 'Clarinex' tablets. As per the terms of the settlement, Lupin will be licensed under the relevant desloratadine patents, and free to commercially launch its generic desloratadine product, on July 1, 2012, or earlier in certain circumstances.

Lupin had earlier filed a Paragraph IV certification to, among others, US Patent Nos. 6,100,274, 7,214,683 and 7,214,684, contesting that these patents were either invalid or had not been infringed upon - resulting in the subsequent litigation by Schering Corp. and Sepracor. Schering-Plough's Clarinex tablets had US sales of $329 million for the year 2007-MAT June 2008, according to IMS Health.

Orion files patent infringement suit against Wockhardt for Stalevo

Orion has filed a patent infringement lawsuit in the US to enforce U.S. Patent Nos. 5,135,950; 5,446,194; and 6,500,867 against Wockhardt USA, Inc. and Wockhardt Limited. Wockhardt seek to market a generic version of Orion Corporation's proprietary drug, Stalevo® (specifically 12.5/200/50 mg strength of carbidopa/entacapone/levodopa) in the United States.

Stalevo is an enhanced levodopa treatment originated by Orion Corporation and marketed in the US by its exclusive licensee, Novartis, for the treatment of Parkinson's disease. In November 2008, Orion was notified that Wockhardt submitted an ANDA with the USFDA that included a Paragraph IV challenge to several of Orion Corporation's patents. By suing to enforce its patents within 45 days from receipt of the Paragraph IV certification notice, Orion is entitled to an automatic stay prohibiting the FDA from approving the applicants ANDA for 30 months, or until an earlier court decision adverse to Orion Corporation's patents in the infringement lawsuit. Orion and Novartis will vigorously defend the intellectual property rights covering Stalevo.

Warner paragraph IV certification for DORYX

Warner Chilcott's subsidiaries and Hospira have received Paragraph IV Certification Notices from Mutual Pharmaceutical Company, Inc. and Mylan Pharmaceuticals Inc. ("Mylan") advising that each such company has filed an ANDA for generic versions of DORYX 100 and 75 mg delayed-release tablets. DORYX is a tetracycline-class oral antibiotic protected by Mayne's Patent No. 6,958,161 (the "161 Patent") which expires in 2022. 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.

Oscient and Ethypharm receive paragraph IV notification from Lupin for Generic fenofibrate

Oscient Pharmaceuticals Corporation and its licensor, Ethypharm SA, have received notice of a Paragraph IV certification on behalf of Lupin Limited, advising of the submission of an ANDA with the USFDA for ANTARA® (fenofibrate) capsules, 130 and 43 mg doses. The notice alleges that U.S. Patent No. 7,101,574, owned by Ethypharm, exclusively licensed to Oscient and listed in the FDA Orange Book for ANTARA, is invalid and/or will not be infringed by Lupin's manufacture, use or sale of the product for which the ANDA was submitted. U.S. Patent No. 7,101,574 is set to expire in 2020. Oscient and Ethypharm have 45 days to commence a patent infringement lawsuit against Lupin that would automatically stay, or bar, the FDA from approving Lupin's ANDA for up to 30 months or until a district court decision in its favor, whichever may occur earlier. Oscient and Ethypharm are currently in the process of evaluating the notice from Lupin and intend to pursue all available legal and regulatory options in defense of ANTARA, including enforcement of their intellectual property rights.

IPblogger will provide update on the developments time to time....