Teva Settles Nuvigil Patent Case With Licenses To Sandoz, Actavis, Lupin, Apotex

(RTTNews) - Teva Pharmaceutical Industries Ltd. (TEVA) Tuesday said it has reached settlements with Sandoz, Actavis, Lupin and Apotex on the U.S. Patent 7,132,570 for its wakefulness product Nuvigil tablets.

Teva will be granting licenses to each of these companies to market their generic products 180 days after Mylan, the first generic company to file an abbreviated new drug application for the 50 mg, 150 mg, and 250 mg dosages of NUVIGIL. The settlements allow Actavis to launch generic 100 mg and 200 mg dosages in June 2016, while the others can launch these dosages 180 days after that. Additional terms of the settlements have not been disclosed. The settlements dismiss a pending appeal with the United States Court of Appeals for the Federal Circuit of a trial court decision, that found the '570 patent to be valid and infringed.

Previously, Teva had settled its patent infringement lawsuit regarding the '570 patent against Mylan, which allowed Mylan to begin selling generic versions of 50 mg, 150 mg, and 250 mg Nuvigil under license beginning in June 2016, or earlier under certain circumstances.