Actavis Files Suit Against FDA over Generic Celebrex

By Pharma News - DCAT Publisher

May 1, 2014

Watson Laboratories, Inc, a subsidiary of the generic-drug company Actavis plc, has filed suit against 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 US. Court of Appeals for the Federal Circuit that resulted in the triggering and subsequent expiration of Teva's sole exclusivity on the product," said the company in a statement.

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" and is also entering 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 to US.Patent No. RE44,048,which describe a class of pyrazolyl benzenesulfonamide compounds used to treat inflammation and inflammation-related disorders.

Last month, both Actavis and Teva Pharmaceutical Industries separately settled litigation with Pfizer regarding their respective generic versions of Celebrex®, allowing them to launch generic versions of the drug beginning in December 2014 or earlier under specified conditions .  

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

Source: Actavis