Auxilium (AUXL) Files Suit Against Watson (WPI) Over Testim 1% Gel

May 24, 2012 7:05 AM EDT Send to a Friend
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) and FCB I LLC have filed a lawsuit against Watson Laboratories, Inc. (NV); Watson Pharmaceuticals, Inc.; and Watson Pharma, Inc. (NYSE: WPI) for infringement of FCB's ten patents listed in the U.S. Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations as covering Testim 1% testosterone gel.

The lawsuit was filed in the United States District Court for the District of New Jersey on May 23, 2012.

Auxilium and FCB filed this lawsuit in response to a notice letter sent by Watson Laboratories, Inc. (NV) regarding its filing with the FDA of Abbreviated New Drug Application ("ANDA") No. 09‑1073 for a generic 1% testosterone gel product. This letter also stated that ANDA No. 09‑1073 contained Paragraph IV certifications, under 21 U.S.C. Section 355(j) of the Federal Food, Drug, and Cosmetic Act, with respect to the nine patents listed in the Orange Book on that date as covering Testim®: U.S. Patent Nos. 7,320,968; 7,608,605; 7,608,606; 7,608,607; 7,608,608; 7,608,609; 7,608,610; 7,935,690; and 8,063,029. On May 15, 2012, a new composition patent covering Testim (U.S. Patent No. 8,178,518) issued. This patent is now also listed in the Orange Book and was included in the patent infringement lawsuit filed against Watson. In total, ten Testim patents are now listed in the Orange Book and are expected to expire on various dates ranging from April 21, 2023 through January 18, 2025. Auxilium and FCB remain committed to protecting their intellectual property rights, including their patent protection for Testim.


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