Mylan confirms Actoplus Met XR patent challenge

Mylan Inc. (Nasdaq: MYL) today confirmed that the company has been sued by Takeda Pharmaceutical Company, Watson Pharmaceuticals and Andrx Labs in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Pioglitazone Hydrochloride and Extended-release Metformin Hydrochloride tablets, 15 mg/1000 mg and 30 mg/1000 mg. This product is the generic version of Actoplus Met® XR, which is indicated to improve glycemic control in adults with type 2 diabetes mellitus.

Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for all strengths and expects to qualify for 180 days of marketing exclusivity upon final FDA approval. The plaintiffs filed the lawsuit in the U.S. District Court for the Southern District of New York.

For the 12 months ending Sept. 30, 2011, Actoplus Met® XR had U.S. sales of approximately $13.9 million for the 15 mg/1000 mg strength product and $7.5 million for the 30 mg/1000 mg product, according to IMS Health.

Currently, Mylan has 170 ANDAs pending FDA approval representing $98.4 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $26.8 billion in annual brand sales, for the 12 months ending June 30, 2011, according to IMS Health.