Watson confirms Welchol patent challenge
PARSIPPANY, N.J. — Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.
The drug maker said Wednesday that it had filed with the Food and Drug Administration for approval of a generic version of Welchol (colesevelam hydrochloride) tablets in the 625-mg strength, made by Daiichi Sankyo, thus challenging the patents covering the drug.
Daiichi Sankyo and Genzyme filed a patent infringement suit against Watson Monday in the U.S. District Court for the District of Delaware, alleging that Watson infringed on two patents covering Welchol. Under the provisions of the Hatch-Waxman Act, the suit puts a stay of FDA approval on the drug until September 2013, or until the companies resolve the matter before the court.
Welchol had sales of $336 million during the 12-month period ended in February 2010, according to IMS Health.