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

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.