FDA decides Teva is sole first-to-file on Provigil®

Teva Pharmaceutical Industries Ltd. announces that the FDA has decided that its wholly owned subsidiary, Teva Pharmaceuticals USA, is sole first-to-file for both Orange Book patents listed for Provigil® (modafinil) and therefore Teva’s ANDA alone is entitled to 180-day exclusivity. Cephalon launched generic Provigil® on March 29, 2012 and the FDA has also decided that such launch triggered the exclusivity.

Teva expects Par Pharmaceutical to launch a second generic product on April 6th pursuant to the agreement with the FTC in connection with the Cephalon acquisition.