Actavis plc confirmed that the United States District Court for the Eastern District of Virginia has ruled that United States Patent No. RE44,048 (the ‘048 Patent) is invalid. Actavis was earlier sued by Plaintiffs G.D. Searle LLC and Pfizer Asia Pacific PTE, Ltd. for infringement of the ‘048 Patent in connection with its Abbreviated New Drug Application directed to Actavis’ generic version of Pfizer’s Celebrex (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules.
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