UCB Unit Kremers Gets License For Generic Concerta Under Settlement

Alza Corp. and Kremers Urban Pharmaceuticals Inc. Sept. 14 ended patent litigation over Kremers’s bid to make and sell a generic version of the attention deficit hyperactivity disorder drug Concerta (Alza Corp. v. Kremers Urban LLC).

Under the settlement, Kremers will receive a license to the patent in question and will be allowed to commercially launch its generic extended-release methylphenidate hydrochloride product on July 1, 2012, or earlier under certain circumstances, pending Food and Drug Administration approval of Kremers’s abbreviated new drug application (ANDA) for the generic drug. Pediatric exclusivity on the patent in the litigation, U.S. Patent ...