Watson Laboratories seeks FDA approval to market Colesevelam HCI tablets

Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Colesevelam HCI 625 mg tablets.  Watson's Colesevelam HCI tablets are a generic version of Daiichi Sankyo, Inc.'s Welchol®.

Daiichi Sankyo and Genzyme Corporation filed suit against Watson on April 18, 2011 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. 5,607,669 and 5,693,675.  Daiichi Sankyo's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA until September 25, 2013, or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.  

For the twelve months ending February 2010, Welchol® tablets had total U.S. sales of approximately $336 million according to IMS Health data.