Teva settles Nuvigil patent litigation with Mylan, which debuts generic Doryx

Israel-based Teva Pharmaceutical Industries (Nasdaq: TEVA), the world’s largest generics companies, said yesterday that it has settled patent infringement litigation regarding US Patent Number 7,132,570 with respect to US rival Mylan’s (Nasdaq: MYL) Abbreviated New Drug Application for Teva’s wakefulness product Nuvigil (armodafinil) tablets.

The settlement allows Mylan to begin selling generic versions of 50mg, 150mg, and 250mg Nuvigil under license beginning in June 2016, or earlier under certain circumstances. Teva understands that Mylan was the first generic company to file ANDA for these dosage strengths of the drug, 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 US District Court for the District of Delaware. Other details of the settlement are confidential, and the agreement itself is subject to review by the US Department of Justice and the Federal Trade Commission

Nuvigil is a Food and Drug Administration-approved prescription medicine used to improve wakefulness in adults who experience excessive sleepiness due to shift work disorder, treated obstructive sleep apnea, or narcolepsy. The drug had total US sales of $296 million for the 12 months ending December 31, 2011, according to IMS Health.