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UPDATE: Teva Settles Nuvigil Litigation with Mylan

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announces that it has settled patent infringement litigation regarding U.S. Patent Number 7,132,570 with respect to Mylan Inc.'s ANDA for Teva's wakefulness product NUVIGILĀ® (armodafinil) tablets. The settlement allows Mylan to begin selling generic versions of 50 mg, 150 mg, and 250 mg NUVIGILĀ® under license beginning in June 2016, or earlier under certain circumstances.

Teva understands that Mylan (NYSE: MYL) was the first generic company to file an abbreviated new drug application (ANDA) for these dosage strengths of NUVIGILĀ®, 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.

Posted-In: News FDA Legal

 

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