April 24, 2014
/PRNewswire/ -- Actavis plc (NYSE: ACT) today 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
, 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
December 31, 2013
had total U.S. sales of approximately
, according to IMS Health data.
Actavis plc (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. Actavis has global headquarters in
and U.S. administrative headquarters in
Parsippany, New Jersey
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. The Company's North American branded pharmaceuticals business is focused principally in the Women's Health, Urology, Gastroenterology and Dermatology therapeutic categories with a strong pipeline of products in various stages of development. Actavis also has a portfolio of five biosimilar products in development in Women's Health and Oncology. Actavis Global Operations has more than 30 manufacturing and distribution facilities around the world, and includes Anda, Inc., a U.S. pharmaceutical product distributor.