Auxilium, FCB I file suit against Watson over generic Testim

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 Testosterone Gel, 1%. Watson's 1% testosterone gel product is a generic version of Auxilium Pharmaceuticals, Inc.'s Testim® 1%. Testim®1% is indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

Auxilium Pharmaceuticals, Inc. and FCB I LLC filed suit against Watson on May 23, 2012 in the United States District Court for the District of New Jersey seeking to prevent Watson from commercializing its 1% testosterone gel product prior to the expiration of certain U.S. patents.  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 March 31, 2012, Testim® had total U.S. sales of approximately $260 million according to IMS Health data.