Actavis plc and Mylan Inc. are suing the Food and Drug Administration, claiming the agency improperly awarded market exclusivity to Teva Pharmaceuticals Industries Inc. for a generic version of Pfizer Inc.'s Celebrex.


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Actavis, Mylan sue FDA over generic Celebrex

April 28th, 2014

DUBLIN, Ireland, and PITTSBURGH – Actavis plc and Mylan Inc. are suing the Food and Drug Administration, claiming the agency improperly awarded market exclusivity to Teva Pharmaceuticals Industries Inc. for a generic version of Pfizer Inc.'s Celebrex.

Actavis said Monday that its subsidiary, Watson Laboratories Inc., has filed suit against the FDA to challenge the agency's decision regarding its entitlement to shared 180-day marketing exclusivity for its generic version of Celebrex (celecoxib) capsules in dosages of 50 mg, 100 mg, 200 mg and 400 mg.

According to Actavis, the FDA improperly awarded sole exclusivity on generic Celebrex to Teva despite an earlier ruling from the U.S. Court of Appeals for the Federal Circuit that resulted in the triggering and subsequent expiration of Teva's sole exclusivity on the product.

As a result, Actavis said it's seeking a judgment from the U.S. District Court for the District of Columbia declaring that the FDA decision is "arbitrary, capricious and contrary to law," as well as the entry of an injunction directing FDA to approve its abbreviated new drug application (ANDA) for generic Celebrex no later than the same date that the first ANDA for a generic version of Celebrex is approved.

Actavis is also asking the court to issue an injunction granting a 180-day exclusivity period for generic Celebrex to Actavis as a first filer of a substantially complete ANDA containing a Paragraph IV certification.

On Friday, Mylan announced that it has filed a lawsuit against the FDA to contest its decision regarding generic drug marketing exclusivity on celecoxib capsules.

According to Mylan, the FDA issued a decision holding that eligibility for 180 days of exclusivity is only available to an applicant who first filed a PIV certification to an original patent and who then also made a timely PIV certification to a reissued patent, despite an earlier appellate court decision that held the original patent invalid, and a subsequent decision holding the reissued patent invalid.

Mylan contends that the FDA "has seriously erred in its decision in this case" and said that it is in a position to receive final approval on May 30, upon expiration of Celebrex's remaining patents. Other companies, including Teva, have settled for a December 2014 launch date and will be unable to launch on May 30, Mylan added.

"We believe the FDA has made an unprecedented error in this case, which clearly caught all industry participants off guard, as evidenced by some who have already settled with Pfizer for December 2014 launch dates, which is post patent expiry," stated Mylan chief executive officer Heather Bresch. "Mylan seeks an order compelling FDA to grant final approval of Mylan's ANDA on May 30, 2014."

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