Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has resolved all disputes with Teva Pharmaceuticals USA, Inc. stemming from litigation brought by Mylan in federal court in the District of Columbia against the U.S. Food and Drug Administration (FDA) concerning Mylan’s abbreviated new drug application (ANDA) for Modafinil Tablets, 100 mg and 200 mg. Modafinil Tablets are the generic version of Cephalon’s Provigil, indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work disorder.
Pursuant to the terms of the agreement with Teva, Mylan is permitted to launch its Modafinil Tablets, 100 mg and 200 mg, on August 10, 2012, which is prior to the expiration of the 180-day marketing exclusivity period granted to Teva. Other details of the settlement are confidential, and the agreement is subject to review by the U.S.
Department of Justice and the Federal Trade Commission.
Modafinil Tablets, 100 mg and 200 mg, had U.S. sales of $1.2 billion for the 12 months ending March 31, 2012, according to IMS Health.