Mylan and Teva Battle for First-to-File Status for Generic Version of Celebrex
Mylan Inc. has entered into a settlement and license agreement with Pfizer Inc. relating to Mylan’s abbreviated new drug application (ANDA) filed with FDA for celecoxib capsules, 50 mg, 100 mg, 200 mg, and 400 mg. This product is the generic version of Pfizer’s Celebrex, which is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults.
Under the terms of the agreement, Mylan will begin selling product at the earliest market formation, however, in any case not later than December 2014. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the US Department of Justice and the Federal Trade Commission, as outlined Mylan in a press statement.
Additionally, Mylan has appealed a decision by the United States District Court for the Northern District of West Virginia denying Mylan’s request for an injunction in its suit against the FDA. “Mylan continues to believe that FDA seriously erred in its decision awarding one party eligibility for 180 days of exclusivity on celecoxib and will continue with this suit independent of the aforementioned settlement,” said the company in its statement.
Teva Pharmaceutical Industries issued a statement to say that the West Virginia district court opinion should give Teva the sole 180-day “first-to-file” exclusivity for generic Celebrex (celecoxib) 100-, 200-, and 400-mg capsules. On April 17, 2014,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, according to Teva.
In a press statement, FDA said that Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50-mg, 100-mg, 200-mg, and 400-mg strengths, and has 180-day exclusivity on the 100-mg, 200-mg, and 400-mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.