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 Moxifloxacin Hydrochloride Ophthalmic Solution USP, 0.5%. Watson's Moxifloxacin Hydrochloride Ophthalmic Solution USP, 0.5% is a generic version of Alcon, Inc.'s Vigamox®, an antibiotic solution that is indicated for the treatment of bacterial conjunctivitis.
Alcon Pharmaceuticals, Ltd. and Alcon Research, Ltd. filed suit against Watson on April 7, 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. 6,716,830 and 7,671,070. Alcon'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 1, 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 28, 2011, Vigamox® had total U.S. sales of approximately $281 million according to IMS Health data.
Watson Pharmaceuticals, Inc.