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news.Actavis has announced that its subsidiary, Watson Laboratories, has filed suit against the US Food and Drug Administration (FDA) challenging its decision regarding its entitlement to shared 180-day marketing exclusivity for its generic version of Celebrex (celecoxib) 50mg, 100mg, 200mg and 400mg capsules.
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Actavis maintains that the FDA improperly awarded sole exclusivity on generic Celebrex to Teva Pharmaceutical Industries despite an earlier ruling from the US 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 US 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 US Patent No. RE44,048.
For the 12 months ending December 31, 2013, Celebrex had total US sales of approximately $2.2bn, according to IMS Health data.
Actavis develops and manufactures generic, brand, branded generic, legacy brands and Over-the-Counter (OTC) pharmaceutical products and has commercial operations in approximately 60 countries.