
Actavis intends to launch the product following the expiration of United States Patent Nos. 5,466,823 and 5,563,165 in May 2014, pending final approval of its Abbreviated New Drug Application by the U.S. Food and Drug Administration (FDA). Based on available information, Actavis believes it 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.
Celebrex is indicated for the treatment of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain and primary dysmenorrhea. For the 12 months ended Dec. 31, 2013, Celebrex had total U.S. sales of approximately $2.2 billion.
Date: March 12, 2014
Source: Actavis