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2 June 2014Americas

Pfizer and Mylan reach Celebrex agreement

Pfizer and Mylan have agreed to settle litigation related to arthritis treatment Celebrex (celecoxib), Mylan announced today, June 2.

Under the parties’ licensing agreement, Mylan will begin selling a generic version of Pfizer’s Celebrex no later than December this year.

Pfizer’s basic compound patent covering Celebrex expired on May 30. In March, the US District Court for the Eastern District of Virginia invalidated a reissue patent covering the drug, which was due to expire in December 2015, opening the market to generic competition much earlier.

Mylan said today that it plans to launch its celecoxib capsules in 50 mg, 100 mg, 200 mg and 400 mg strengths.

It also announced that it had appealed against the US District Court for the Northern District of West Virginia’s decision that denied its request for an injunction in its case against the US Food and Drug Administration (FDA).

On April 25, Mylan sued the FDA, challenging the agency’s decision not to allow it 180 days of market exclusivity for its celecoxib tablets upon the basic patent’s expiry.

Three days later, it requested that the court enjoin the FDA from withholding final approval, upon expiry of the basic patent, to any generic drug maker that was the first to file an Abbreviated New Drug Application with the FDA for approval to market a generic version of Celebrex.

In the first quarter of 2014, worldwide sales of Celebrex totalled $624 million.

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