Teva, Mylan End Generic Provigil Fight; Mylan Can Sell Before Teva’s 180 Days Over

Pittsburgh-based Mylan Inc. June 8 said it has ended all disputes with Teva Pharmaceuticals USA Inc. regarding Mylan’s abbreviated new drug application (ANDA) to make and sell a generic version of the narcolepsy and sleep apnea treatment Provigil (modafinil tablets) in 100 mg and 200 mg strengths.

In April, Mylan Inc.'s subsidiary, Mylan Pharmaceuticals Inc., sued the Food and Drug Administration in the U.S. District Court for the District of Columbia, seeking to overturn an agency decision that awarded Teva sole 180-day exclusivity for generic Provigil (10 PLIR 499, 4/13/12).

Under the parties’ settlement, Mylan will be allowed ...