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Mylan, Pfizer reach settlement on Celebrex generic
June 2nd, 2014
PITTSBURGH – Mylan Inc. has entered into a settlement and license agreement to market a generic version of Pfizer Inc.'s anti-inflammatory drug Celebrex (celecoxib).
Mylan said Monday that under the patent settlement agreement it will begin selling its celecoxib capsules (50 mg, 100 mg, 200 mg and 400 mg) "at the earliest market formation, however in any case not later than December 2014." Mylan has filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration for the product.
The company said other terms and conditions of the settlement and license agreement are confidential, and the agreement is subject to review by the Department of Justice and the Federal Trade Commission.
Mylan also reported that it has appealed last week's decision by the U.S District Court for the Northern District of West Virginia denying its request for an injunction in its suit against the FDA. Mylan and Actavis plc in late April announced that they were suing the FDA, claiming the agency improperly awarded market exclusivity to Teva Pharmaceuticals Industries Inc. for a generic version of Celebrex.
"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," Mylan stated Monday.
Teva entered into a settlement agreement with Pfizer in April regarding a generic version of Celebrex capsules in dosages of 50, 100, 200 and 400 mg. Under the settlement, Teva may launch its generic versions in December 2014, or earlier under certain circumstances. Teva said it has received tentative approval from the FDA for all strengths.
Celebrex 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. For the 12 months ended March 31, Celebrex had U.S. sales of about $2.34 billion, according to figures from IMS Health reported by Mylan.