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Actavis Sues FDA Regarding Delay of Generic Celebrex Approval

Tue, 04/29/2014 - 8:29am

Actavis announced that its subsidiary, Watson Laboratories, Inc., has filed suit against the U.S. Food and Drug Administration (FDA) challenging the Agency's decision regarding its entitlement to shared 180-day marketing exclusivity for its generic version of Celebrex (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules.

Actavis maintains that the FDA improperly awarded sole exclusivity on generic Celebrex to Teva Pharmaceutical Industries Ltd., 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.

Actavis is 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 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 to U.S. Patent No. RE44,048.

For the 12 months ending December 31, 2013, Celebrex@ had total U.S. sales of approximately $2.2 billion, according to IMS Health data.
 

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