PITTSBURGH — Mylan announced that its subsidiary has resolved all disputes with Teva pertaining to the sale of generic versions of a sleep disorder drug.
Under a new agreement with Teva, Mylan Pharmaceuticals is permitted to launch modafinil tablets in the 100-mg and 200-mg strengths, a generic version of Cephalon's Provigil, prior to the Aug. 10 expiration of a 180-day marketing exclusivity period granted to Teva. As previously reported, Mylan Pharmaceuticals filed a suit in federal court in the District of Columbia against the Food and Drug Administration in relation to Mylan's abbreviated new drug application for modafinil tablets in the 100-mg and 200-mg strengths.
Other details of the settlement are confidential and the agreement is subject to review by the Department of Justice and the Federal Trade Commission, the companies said.
U.S. sales for modafinil tablets in the 100-mg and 200-mg strengths were $1.2 billion for the 12 months ended in March, according to IMS Health.