Reuters: Regulatory News: Mylan, Teva settle row over sale of sleep drug

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Mylan, Teva settle row over sale of sleep drug Jun 8th 2012, 12:37 June 8 | Fri Jun 8, 2012 8:37am EDT June 8 (Reuters) - Mylan Inc said it resolved disputes with Teva Pharmaceutical Industries Ltd over the sale of U.S. generic versions of the wide-selling sleep-disorder drug Provigil. Mylan, the world's No. 3 generic drugmaker, had challenged Teva's right to 180 days as the exclusive seller of a generic version of Provigil, typically awarded to the company that first challenges the patents on a brand-name drug. Teva is the world's largest generic drugmaker. The situation with Provigil, also known as modafinil, is unusual because Teva acquired the drug's maker, Cephalon, for $6.8 billion last year to build its brand-drug franchise. Mylan had said that since Teva could not infringe its own patents, it was not entitled to the exclusivity, and sued the U.S. Food and Drug Administration over granting the right to its rival. On Friday, Mylan said the agreement would allow it to launch modafinil tablets on Aug. 10, before the expiration of the exclusivity period granted to Teva. Provigil sales totaled $1.2 billion in the United States for the year ended in March, Mylan said, citing figures from IMS Health.

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