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Auxilium Pharmaceuticals, Inc. Announces Court Grants Upsher-Smith Laboratories Motion For Summary Judgment
Date:12/4/2013

CHESTERBROOK, Pa., Dec. 4, 2013 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) ("Auxilium") announced today that the United States District Court for the District of Delaware ("Court") granted Upsher-Smith Laboratories, Inc.'s ("USL") motion for summary judgment with respect to its attempts to bring a testosterone gel product to market via its 505(b)(2) NDA using Auxilium's Testim® product as its reference listed drug.

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"We are very disappointed with the Court's decision," said Adrian Adams, Chief Executive Officer and President of Auxilium. "We remain committed to protecting and enforcing our intellectual property rights, and we are currently considering all avenues, including an appeal."

On December 28, 2012, Auxilium and CPEX Pharmaceuticals, Inc. ("CPEX") became aware of a notice from USL that advised them of USL's filing of a 505(b)(2) New Drug Application containing a Paragraph IV certification under 21 U.S.C. Section 314.52(c) for testosterone gel (the "USL NDA"). This Paragraph IV certification notice refers to the ten U.S. patents, covering Testim, that are listed in the Orange Book. These ten patents are owned by FCB I LLC (successor-in-interest to CPEX) ("FCB") and are exclusively licensed to Auxilium and will expire between 2023 and 2025. On January 28, 2013, Auxilium and FCB filed a lawsuit in the United States District Court for the District of Delaware against USL for infringement of all ten patents. As part of the legal proceedings between the companies, USL filed a motion for summary judgment that its proposed product does not infringe any of the patents. The Court has now granted USL's motion for summary judgme
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SOURCE Auxilium Pharmaceuticals, Inc.
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