Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) announced that it has settled patent infringement litigation regarding the US patent of Mylan Inc.'s ANDA for Teva’s wakefulness product NUVIGIL (armodafinil) tablets.
Teva said that 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 added that it 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.
The court hearing on the 570 patent against the subsequent ANDA filers is scheduled to begin in July 2012 in the US 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, sleep apnea or narcolepsy.
Published by Globes, Israel business news - www.globes-online.com - on May 1, 2012
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