(By Balashesan) Watson Pharmaceuticals Inc.
) confirmed patent challenge for Auxilium Pharmaceuticals
) Testim to treat adult males who have low or no testosterone.
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's Testim 1%, which is indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
Auxilium and FCB I LLC filed suit against Watson on May 23 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.
Testim had total U.S. sales of about $260 million for the twelve months ending March 31, 2012, according to IMS Health data.
Watson is an integrated global pharmaceutical company engaged in the development, manufacturing, marketing, sale and distribution of generic and brand pharmaceutical products. It operates in three segments: Global Generics, Global Brands and Distribution.
WPI closed Thursday's regular session up 2.90% at $72.76. The stock has been trading between $55 and $77.73 for the past 52 weeks.