Teva Receives Favorable Court Decision Regarding Generic Celebrex® Capsules; Teva Should Receive Sole Exclusivity for Generic Celebrex Capsules.
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Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announced that the U.S. District Court for the Northern District of West Virginia denied a motion filed by Mylan and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex (celecoxib) 100, 200 and 400 mg capsules.
On April 17th, Teva entered into a settlement agreement with Pfizer related to Teva’s generic version of Celebrex® (celecoxib) 50, 100, 200 and 400 mg capsules in the United States. Under the terms of the settlement, Teva may launch its generic versions in December, 2014, or earlier under certain circumstances.
Teva has received tentative approval from the U.S. Food and Drug Administration (FDA) for all strengths. Sales of Celebrex were $2.2 billion in the U.S. according to IMS data as of December, 2013.