Actavis plc announced that it has entered into an agreement with Pfizer Inc. to settle all outstanding patent litigation related to Actavis’ generic version of Celebrex (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules. Celebrex is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults.
Under the terms of the agreement, Pfizer will grant Actavis a license to market its generic Celebrex beginning in December 2014, or earlier under certain circumstances. Other details of the settlement were not disclosed.
Launch of Actavis’ product is contingent upon Actavis receiving final approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for generic Celebrex. Based on available information, Actavis believes it may be a “first applicant” to file an ANDA for the generic version of Celebrex and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity or shared exclusivity, subject to the FDA’s determination that the product qualifies for an award of exclusivity under the provisions of the Hatch-Waxman Act.
For the 12 months ending Dec. 31, 2013, Celebrex had total U.S. sales of approximately $2.2 billion, according to IMS Health data.
Date: April 24, 2014
Filed Under: Drug Discovery