Auxilium (AUXL) Notified of Paragraph IV Filing for Testosterone Gel

January 3, 2013 7:03 AM EST
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Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) and Xstelos Holdings, Inc. announced that they have received a notice from Upsher-Smith Laboratories, Inc. ("USL") that advises them of USL's filing of a 505(b)(2) New Drug Application (NDA) containing a Paragraph IV certification under 21 U.S.C. Section 314.52(c) for testosterone gel. This Paragraph IV certification notice refers to the ten U.S. patents, covering TestimĀ®, 1% testosterone gel, that are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration. These ten patents are owned by FCB I LLC, an indirect majority owned subsidiary of Xstelos. Xstelos holds the assets of CPEX Pharmaceuticals, Inc., the predecessor owner of the patents. The referenced Testim patents will expire between 2023 and 2025.

Auxilium and Xstelos are currently reviewing the details of this notice from Upsher Smith. Auxilium and Xstelos intend to pursue all available legal and regulatory options in defense of Testim, including enforcement of their intellectual property rights and approved labeling.

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