Mylan seeks approval for generic diabetes drug
PITTSBURGH — Generic drug maker Mylan is challenging the patent on a drug used to treat diabetes, the company said Monday.
Mylan said that it was sued by Takeda Pharmaceutical, Watson Pharmaceuticals and Andrx Labs in the U.S. District Court for the Southern District of New York in response to Mylan's filing a regulatory approval application with the Food and Drug Administration for a generic version of Actoplus Met XR (pioglitazone hydrochloride and metformin hydrochloride) extended-release tablets in the 15-mg/1,000-mg and 30-mg/1,000-mg strengths.
The application contained a paragraph IV certification, a legal assertion that Actoplus Met XR's patent protection is invalid, unenforceable or won't be infringed.
Actoplus Met XR had sales of about $21.4 million in the two strengths during the 12-month period ended in September, according to IMS Health.