Teva Pharmaceutical Industries Ltd. (TEVA: Quote) on Thursday said 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 and the FDA has also decided that such launch triggered the exclusivity.
Teva expects Par Pharmaceutical to launch a second generic product on April 6 pursuant to the agreement with the FTC in connection with the Cephalon acquisition.
Click here to receive FREE breaking news email alerts for Teva Pharmaceutical Industries Limited and others in your portfolio
by RTT Staff Writer
For comments and feedback: email@example.com