Mylan's subsidiary, Mylan Pharmaceuticals, has settled Provigil litigation with Teva Pharmaceutical USA.
The settlement follows the Mylan litiagtion against the US Food and Drug Administration (FDA) regarding Mylan's abbreviated new drug application for Modafinil Tablets, 100mg and 200mg.
As a part of the agreement with Teva, Mylan is allowed to introduce its Modafinil Tablets, 100mg and 200mg, on 10 August 2012, which is prior to the expiration of the 180-day marketing exclusivity period granted to Teva.
The agreement is subject to review by the US Department of Justice and the Federal Trade Commission.
Modafinil Tablets, which are the generic version of Cephalon's Provigil, are used to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work disorder.
