Mylan Inc. confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Endo Pharmaceuticals in connection with the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for Frovatriptan Succinate EQ, 2.5 mg base tablets. This product is the generic version of 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 lawsuit 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. Forty-three of these pending ANDAs, including Frovatriptan Succinate EQ, 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.