PITTSBURGH — Mylan announced on Monday that it has entered into a settlement and license agreement with Pfizer relating to Mylan's abbreviated new drug application filed with the U.S. Food and Drug Administration for celecoxib capsules, 50-mg, 100-mg, 200-mg and 400-mg strengths.
This product is the generic version of 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. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission, Mylan stated.
In addition, Mylan has appealed the 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 the 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, the company stated.
As reported by Drug Store News, 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
For the 12 months ended March 31, 2014, Celebrex had U.S. sales of approximately $2.34 billion, according to IMS Health.