June 8 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
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