Auxilium Pharmaceuticals, Inc. (Auxilium), a specialty biopharmaceutical company, and FCB I LLC (FCB), an indirect, majority-owned subsidiary of Xstelos Holdings, Inc., have announced that the United States Patent and Trademark Office (USPTO) has issued US Patent No. 8,178,518 covering, among other things, Testim 1% testosterone gel, marketed by Auxilium under license from FCB.
The newly issued patent, which claims certain pharmaceutical compositions comprising testosterone, is expected to expire in April 2023. Auxilium has also submitted the patent for listing in the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the US Food and Drug Administration.
"We are very pleased that, in addition to the nine previously issued patents covering methods using Testim, the franchise is now further protected by a composition patent," said Adrian Adams, chief executive officer and president of Auxilium. "This further strengthens our Testim patent estate which we intend to vigorously defend by pursuing all available legal and regulatory options in defense of Testim, including enforcement of all intellectual property rights and approved labelling."