Teva, Mylan settle patent infringement litigation for Nuvigil

Apr 30 2012

Teva Pharmaceutical Industries Ltd. (TEVA), one of the world's largest producers of pharmaceuticals, announces that it has settled patent infringement litigation regarding U.S. Patent Number 7,132,570 (the "'570 patent") with respect to Mylan Inc.'s ANDA for Teva's wakefulness product NUVIGIL® (armodafinil) tablets.

The settlement allows 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. Teva understands that Mylan was the first generic company to file an abbreviated new drug application (ANDA) for these dosage strengths of NUVIGIL®, which are the currently marketed strengths. Trial on the '570 patent against the subsequent ANDA filers is scheduled to begin in July 2012 in the United States District Court for the District of Delaware.

NUVIGIL® is an FDA-approved prescription medicine used to improve wakefulness in adults who experience excessive sleepiness due to shift work disorder, treated obstructive sleep apnea, or narcolepsy.

Source Teva Pharmaceutical Industries Ltd.