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XTLS > SEC Filings for XTLS > Form 8-K on 14-Sep-2012All Recent SEC Filings

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Form 8-K for XSTELOS HOLDINGS, INC.


14-Sep-2012

Other Events


Item 8.01 Other Events.

On September 11, 2012, FCB I LLC ("FCB") and Auxilium Pharmaceuticals, Inc. ("Auxilium") learned that Upsher-Smith Laboratories, Inc. ("Upsher-Smith") had filed on September 10, 2012 in the United States District Court for the District of New Jersey a complaint for declaratory judgment seeking a declaration of non-infringement and/or invalidity of FCB's U.S. Patent Nos.: 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. FCB is an indirect, majority-owned subsidiary of Xstelos Holdings, Inc. ("Xstelos"). As Xstelos has previously disclosed, all of the eight referenced patents cover Auxilium's Testim® 1% testosterone gel, and the eight referenced patents are among the ten FCB patents covering Testim that are currently listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration. The referenced patents will expire between 2023 and 2025. FCB and Auxilium are currently reviewing the details of the complaint from Upsher-Smith and intend to pursue all available legal and regulatory options in defense of Testim, including enforcement of FCB's and Auxilium's intellectual property rights and approved labeling.


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