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United States : MYLAN PHARMACEUTICALS and PFIZEr reach agreement on CELEBREX.

Mylan Pharmaceuticals reached an agreement with Pfizer Inc. to market a generic equivalent of Celebrex, even though the company is appealing a federal court's refusal to block the US Food & Drug Administration (FDA) from granting a competitor generic exclusivity for 180 days.

The settlement relates to Mylan's Abbreviated New Drug Application for Celecoxib capsules in 50, 100, 200 and 400 milligram versions. It followed US District Judge Irene Keeley's refusal to block the FDA from granting generic exclusivity to Teva, a competitor.

Celecoxib is the generic version of Pfizer's Celebrex, that is used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis as well as for the management of acute pain in adults.

Mylan will begin selling its product at the earliest market formation, but 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 US Department of Justice and the Federal Trade Commission.

Mylan believes that FDA erred in its decision awarding one party eligibility for 180 days of exclusivity on Celecoxib, and will continue with that suit independent of the aforementioned settlement.

Mylan failed to prove it would be harmed if the court didn't block the FDA from awarding 180-day exclusivity to Teva or that FDA had erred in awarding it to that company.

Teva was the first to file an abbreviated new drug application, in 2003 for its generic version of Pfizer's Celebrex. Pfizer immediately sued Teva for patent infringement. A federal judge found that Pfizer in 2008 that decision was overturned in part by a federal appeals court, which found deficiencies in several of Pfizer's patent claims.

Pfizer spent the next 5 years correcting the deficiencies in its original patent and in 2013 it was reissued. Teva was among several companies, including Mylan, that immediately filed ANDAs.

Mylan stood to lose tens of millions of dollars in profits if Teva is given 180-day exclusivity on the reissued patent.

Mylan contends that by granting an injunction and opening up the generic market to multiple first-filers, the public will be served by robust generic competition for Celecoxib.

For the 12 months ending March 31, Mylan said IMS Health reported Celebrex had US sales of approximately $2.34 billion.

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Publication:Mena Report
Date:Jun 4, 2014
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