Watson begins shipping generic diabetes drug
NEW YORK -- Watson Pharmaceuticals Inc. said Friday that it began shipping a generic version of the type 2 diabetes treatment Actos after receiving final approval from the Food and Drug Administration.
The Parsippany, N.J.-based company had sued the FDA this summer to gain approval for the drug and sought shared marketing exclusivity for its generic version of the drug.
After Watson sued the FDA, the company said Mylan Pharmaceuticals Inc. intervened as a defendant in the action. On Monday, the company said the U.S. District Court for the District of Columbia ruled in favor of Watson and ordered the FDA to approve Watson's request.
Mylan appealed the judgment to the U.S. Court of Appeals for the District of Columbia Circuit. That court denied Mylan's motion to halt the judgment pending the appeal.
Actos is marketed by Takeda Pharmaceuticals of Japan. Under terms of a 2010 legal settlement between Watson and Takeda, Takeda licensed the U.S. patents to Watson and allowed it to start marketing a generic on Aug. 17, 2012.
The patents supporting Actos expire in 2016.