Mylan confirms Actoplus patent challenge

US generic drugmaker Mylan (Nasdaq: MYL) has confirmed that it has been sued by Takeda Pharmaceutical (TYO: 4502), Watson Pharmaceuticals (NYSE: WPI) and privately-held Andrx Labs in connection with the filing of an Abbreviated New Drug Application with the US Food and Drug Administration for pioglitazone hydrochloride and extended-release metformin HCL tablets, 15mg/1,000mg and 30mg/1,000 mg. This product is the generic version of Takeda’s 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 of Actoplus Met XR 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 Southern District of New York.

For the 12 months ending September 30, 2011, Actoplus Met XR had US sales of around $13.9 million for the 15mg/1,000mg strength product and $7.5 million for the 30mg/1,000mg product, according to IMS Health.