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Auxilium Pharmaceuticals, Inc. and Xstelos Holdings, Inc. File Lawsuit Against Upsher-Smith Laboratories, Inc. for Infringement of Testim® Patents
PR Newswire - Mon Jan 28, 4:20PM CST
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) ("Auxilium") and Xstelos Holdings, Inc. (OTCQB: XTLS) ("Xstelos") announced today that they filed a lawsuit against Upsher-Smith Laboratories, Inc. ("USL") for infringement of ten U.S. patents covering Testim, 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 ("FDA"). These ten patents are owned by FCB I LLC, an indirect majority owned subsidiary of Xstelos, and are exclusively licensed to Auxilium. Xstelos holds the assets of CPEX Pharmaceuticals, Inc., the predecessor owner of the patents. The lawsuit was filed in the United States District Court for the District of Delaware on January 28, 2013.
Patent Challenge for Auxilium Pharma - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Fri Jan 04, 6:47PM CST
Patent Challenge from Upsher-Smith Laboratorie for Auxilium Pharma
Auxilium Pharmaceuticals, Inc. and Xstelos Holdings, Inc. Receive 505(b)(2) Paragraph IV Certification Notice from Upsher-Smith Laboratories, Inc. for Testim®
PR Newswire - Thu Jan 03, 6:00AM CST
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) ("Auxilium") and Xstelos Holdings, Inc. (OTCQB: XTLS) ("Xstelos") today 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 Testim®, 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.