Teva Pharmaceutical Industries Ltd. (TEVA) 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.
by RTT Staff Writer
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