Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has received a favorable decision from a court in the US on arthritis treatment Celebrex. The company announced on Thursday that the US 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 (US Food and Drug Administration) under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex (celecoxib) 100, 200 and 400 mg capsules.
On 17 April, Teva entered into a settlement agreement with Pfizer related to Teva’s generic version of Celebrex 50, 100, 200 and 400 mg capsules in the US. 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. The company says that sales of Celebrex were $2.2 billion in the US according to IMS data as of December, 2013.
Published by Globes [online], Israel business news - www.globes-online.com - on June 1, 2014
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