Watson Pharmaceuticals, Inc. confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%. Watson's Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is a generic version of Alcon, Inc.'s Pataday (olopatadine hydrochloride ophthalmic solution) 0.2%, which is indicated for the treatment of ocular itching associated with allergic conjunctivitis.
Alcon Research, Ltd., Alcon Pharmaceuticals, Ltd., and Kyowa Hakko Kirin Co., Ltd. filed suit against Watson on June 9, 2011 in the United States District Court for the Southern District of Indiana seeking to prevent Watson from commercializing its product prior to the expiration of US Patent Nos. 5,641,805, 6,995,186, and 7,402,609. 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 October 29, 2013, or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
For the twelve months ending April 30, 2011, Pataday had total US sales of approximately $ 224 million according to IMS Health data.
Watson Pharmaceuticals, Inc. is an integrated global specialty pharmaceutical company and is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women's health.