Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. – Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Metformin Hydrochloride Extended-release Tablets USP, 1000 mg. Watson’s Metformin Hydrochloride Extended-release Tablets are a generic version of Depomed, Inc.’s Glumetza. Glumetza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Depomed, Inc. and Valeant International (Barbados) SRL filed suit against Watson on April 18, 2012 in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent Nos. 6,488,962 and 7,780,987. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson’s ANDA for up to 30 months from the date the plaintiffs received notice of Watson’s ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
For the twelve months ending February 28, 2012, Glumetza had total U.S. sales of approximately $80 million according to IMS Health data.
