Endo Pharma sues Mylan over Frova patent infringement

US generic drugmaker Mylan (Nasdaq: MYL) yesterday confirmed that the company and its subsidiary Mylan Pharmaceuticals have been sued by Endo Pharmaceuticals (NasdaqGS: ENDP) in connection with the filing of an Abbreviated New Drug Application with the US Food and Drug Administration for frovatriptan succinate EQ, 2.5mg base tablets, a copy version of Endo’s Frova, which is indicated for the treatment of symptoms associated with acute migraine headaches, with or without aura, in adults.

Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification and expects to qualify for 180 days of marketing exclusivity upon final FDA approval. The plaintiffs filed the law suit in the US District Court for the District of Delaware.

For the 12 months ending June 30, 2011, Endo had total Frova sales of $68.197 million, according to IMS Health. Mylan currently has 162 ANDAs pending FDA approval representing $94.4 billion in annual sales. 43 of these pending ANDAs, including frovatriptan are potential first-to-file opportunities, representing $25.5 billion in annual brand sales, for the 12 months ending June 30, 2011, according to IMS Health.