Mylan confirms first-to-file patent challenge of AMRIX capsules



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Mylan Inc. has confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Cephalon Inc., Eurand Inc. and Anesta AG in connection with the filing of an Abbreviated New Drug Application (ANDA) for Cyclobenzaprine Hydrochloride (HCl) Extended-release (ER) Capsules, 15 mg and 30 mg, the generic version of AMRIX Capsules.

Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for the product and expects to be awarded 180 days of sole marketing exclusivity once final approval is obtained. Mylan filed its ANDA with the U.S. Food and Drug Administration (FDA) in August. Cephalon, Eurand and Anesta filed a lawsuit Nov. 26 in the U.S. District Court for the District of Delaware alleging infringement of U.S. Patent No. 7,387,793.

Cyclobenzaprine HCl ER Capsules, a muscle relaxant introduced to the market in October 2007, had approximately $53 million in sales for the twelve months ending Sept. 30 and approximately $19 million for the quarter ending Sept. 30, according to IMS Health.

Currently, Mylan has 113 ANDAs pending FDA approval, 24 of which are potential first-to-file opportunities.

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Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Anesta in connection with its Amrix (cyclobenzaprine hydrochloride) extended-release capsules, 15mg and 30mg. Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Amrix with the U.S.

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Mylan Inc. has confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Novartis in connection with Fluvastatin Capsules USP, 20 mg (base) and 40 mg (base), the generic version of Novartis’ Lescol(R) Capsules. Mylan believes it is the first company to file a substantially complete Abbreviated New Drug Application

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Mylan Inc. has announced that its subsidiary, Mylan Pharmaceuticals Inc., received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules USP, 10 mg and 20 mg. Fluoxetine Capsules, indicated for the treatment of premenstrual dysphoric disorder (PMDD) are the generic version of Eli Lilly’s

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Mylan Inc. has announced that it and its subsidiary, Mylan Pharmaceuticals Inc., have entered into a settlement agreement with Novartis Pharmaceuticals Corp., Novartis Corp. and Novartis International AG related to Letrozole Tablets, the generic version of Novartis’ Femara. Mylan’s Vice Chairman and CEO Robert J. Coury commented: “We are very pleased to have reached this

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Mylan Inc. has announced that its subsidiary Dey L.P. has been issued several additional U.S. patents protecting the company’s Perforomist(R) Inhalation Solution, a chronic obstructive pulmonary disease (COPD) treatment. U.S. Patent No. 7,462,645 was issued Dec. 9, 2008, and is directed to treatment through the administration of a ready-to-use, storage stable composition of formoterol. This

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