Watson seeks approval for generic Type 2 diabetes drug
PARSIPPANY, N.J. — Generic drug maker Watson is challenging the patent protection on a drug used to treat Type 2 diabetes.
Watson said Thursday that it had filed with the Food and Drug Administration for approval of a generic version of Depomed's Glumetza (metformin hydrochloride extended-release tablets) in the 1,000-mg strength.
In response, Depomed and a division of Valeant International filed suit against Watson Wednesday in the U.S. District Court for the District of Delaware, alleging that Watson's application infringes two patents covering Glumetza. Under the Hatch-Waxman Act, the suit puts a stay of FDA approval on Watson's drug for 30 months, or until Watson and the companies suing it settle the case.