US Pharm. 2012;36(2):40.Mylan Inc. 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 FDA for pioglitazone hydrochloride and extended-release metformin hydrochloride tablets, 15 mg/1,000 mg and 30 mg/1,000 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 September 30, 2011, Actoplus Met XR generated U.S. sales of approximately $13.9 million for the 15-mg/1,000-mg-strength product and $7.5 million for the 30-mg/1,000-mg-strength product, according to IMS Health.