Market Overview

Mylan Announces Settlement Agreement for its First-to-File Generic Version of Nuvigil


Mylan Inc. (Nasdaq: MYL) today announced that it has entered into a settlement agreement with Teva (NASDAQ: TEVA) that will resolve pending patent litigation related to Nuvigil® (Armodafinil Tablets, 50 mg, 150 mg, and 250 mg).

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. Pursuant to the agreement, pending litigation will be dismissed. Other details of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission.

Mylan was the first company to have filed a substantially complete abbreviated new drug application (ANDA) containing a Paragraph IV certification with the U.S. Food and Drug Administration (FDA) for Armodafinil Tablets, 50 mg, 150 mg, and 250 mg, and anticipates that it will be entitled to 180 days of generic market exclusivity. This product, which is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy and shift work disorder, had total U.S. sales of $296 million for the 12 months ending Dec. 31, 2011, according to IMS Health.

Posted-In: News FDA


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