HAYWARD, Calif.--(BUSINESS WIRE)--Jan. 15, 2008 - IMPAX Laboratories, Inc. (OTC:IPXL) today announced that it has filed a lawsuit against Medicis Pharmaceutical Corporation in the United States District Court for the Northern District of California requesting a declaration that IMPAX does not infringe any valid claims of U.S. Patent No. 5,908,838 related to IMPAX's filing in October 2007 of an Abbreviated New Drug Application (ANDA) for minocycline hydrochloride extended-release tablets, a generic version of Solodyn(R).
IMPAX's ANDA does not contain any patent certification under Paragraph IV of the Hatch-Waxman amendments because no patents for the SOLODYN(R) product are listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U. S. Food and Drug Administration. Certain antibiotic products are not subject to these Hatch-Waxman procedures and, therefore, do not have patents listed in the Orange Book and are not subject to the patent certification requirements.
Medicis Pharmaceutical Corporation markets SOLODYN(R) tablets for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. U.S. sales of SOLODYN(R) tablets were approximately $216.7 million in the 12 months ended November 30, 2007.
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