Mylan Inc., a global pharmaceutical company, has entered into a settlement and license agreement with Pfizer Inc. relating to Mylan’s Abbreviated New Drug Application (ANDA) filed with the US Food and Drug Administration (FDA) for Celecoxib capsules, 50 mg, 100 mg, 200 mg and 400 mg. 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 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.
Additionally, 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 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.
For the 12 months ending March 31, 2014, Celebrex had US sales of approximately $2.34 billion, according to IMS Health.