Mylan confirms first-to-file Amrix patent challenge

Mylan and subsidiary Mylan Pharmaceuticals have been sued by Cephalon, Eurand and Anesta AG in connection with the filing of an Abbreviated New Drug Application for cyclobenzaprine HCl extended-release capsules, 15mg and 30mg, the generic version of Amrix capsules.

Mylan says it believes it is the first 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. The firm submitted its ANDA with the Food and Drug Administration in August. Cephalon, Eurand and Anesta filed a law suit November 26 alleging infringement of US patent no 7,387,793.

Cyclobenzaprine, a muscle relaxant introduced to the market in October 2007, had around $53.0 million in sales for the 12 months ending September 30 and about $19.0 million for the quarter ending that date, according to IMS Health.