JERUSALEM — Teva Pharmaceutical Industries announced on Friday that the U.S. District Court for the Northern District of West Virginia has 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 17, 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 FDA for all strengths. Sales of Celebrex were $2.2 billion in the U.S. according to IMS data as of December 2013.