In the wake of a federal court ruling, Mylan Inc. and Actavis plc plan to roll out generic versions of Pfizer Inc.'s blockbuster anti-inflammatory drug Celebrex in the United States this spring.


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Mylan, Actavis ready Celebrex generics after court win

March 13th, 2014

NEW YORK – In the wake of a federal court ruling, Mylan Inc. and Actavis plc plan to roll out generic versions of Pfizer Inc.'s blockbuster anti-inflammatory drug Celebrex in the United States this spring.

Both Mylan and Actavis confirmed that the U.S. District Court for the Eastern District of Virginia has invalidated a patent for Celebrex (celecoxib) in 50-mg, 100-mg, 200-mg and 400-mg capsules.

The two companies said this week that they aim to release their Celebrex generics in May, pending final approval of their Abbreviated New Drug Applications (ANDAs) by the Food and Drug Administration.

Mylan and Actavis were sued by G.D. Searle LLC and Pfizer Asia Pacific PTE Ltd. for allegedly infringing the Celebrex patent when they filed ANDAs for their generic versions.

Mylan said it believes it may be entitled to 180 days of shared generic market exclusivity on the 100-mg, 200-mg and 400-mg strengths, subject to the FDA's determination that its generic product qualifies for exclusivity under the Hatch-Waxman Act. Actavis said it may be entitled to 180 days of generic market exclusivity or shared exclusivity, subject to the FDA's determination under the act.

A nonsteroidal anti-inflammatory drug (NSAID), Celebrex is indicated for the treatment of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain and primary dysmenorrhea. The medication had total U.S. sales of about $2.2 billion for the 12 months ended Dec. 31, according to Mylan and Actavis.

Pfizer said Tuesday that it disagrees with the ruling, which invalidated the reissue patent for Celebrex it was granted about a year ago, and stated that the company "will pursue all available remedies, including an immediate appeal of the court's decision."

According to Pfizer, a trial was set to begin on March 19 in which the company charged that Teva Pharmaceuticals USA Inc., Mylan Pharmaceuticals Inc., Watson Laboratories Inc. (now Actavis), Lupin Pharmaceuticals USA, Inc., Apotex Corp. and Apotex Inc. infringed on its Celebrex reissue patent.

Pfizer said those companies had filed ANDAs seeking approval to market a generic form of celecoxib in the United States starting on May 30, 2014, when Pfizer's basic Celebrex compound patent (including a six-month pediatric exclusivity period) expires. According to Pfizer, that date is 18 months before the Dec. 2, 2015. expiration (including the six-month pediatric exclusivity) of its Celebrex reissue patent, which covers methods of treating osteoarthritis and other approved conditions with celecoxib.

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