Inpex files suit against Medicis over patent for Solodyn

HAYWARD, Calif. Impax Laboratories has filed a lawsuit against Medicis Pharmaceuticals in the U.S. District Court for the Northern District of California requesting a declaration that it does not infringe any valid claims of a patent for the anti-acne drug Solodyn with its application for a generic version.

Impax’s application does not contain any patent certification under Paragraph IV of the Hatch-Waxman amendments because no patents for the Solodyn product are listed in the Orange Book published by the 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.

U.S. sales of Solodyn tablets were approximately $216.7 million in the 12 months ended Nov. 30, 2007. Impax filed for a generic application of Solodyn, minocycline hydrochloride extended-release tablets, in October 2007.