DUBLIN, March 12, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today 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 December 31, 2013, Celebrex® had total U.S. sales of approximately $2.2 billion.
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 Dublin, Ireland and U.S. administrative headquarters in Parsippany, New Jersey, USA.
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.
For press release and other company information, visit Actavis' Web site at http://www.actavis.com.
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing information as of the date of this release. It is important to note that Actavis' goals and expectations are not predictions of actual performance. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' business. These factors include, among others, the inherent uncertainty associated with financial projections; the difficulty of predicting the timing or outcome of product development efforts and FDA approvals or actions, if any; the difficulty of predicting the timing or outcome of the pending patent litigation, including potential appeals, and risks that an adverse outcome in such litigation and appeals could render Actavis liable for substantial damages; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Actavis and its third party manufacturers' facilities, products and/or businesses; and such other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis plc's Annual Report on Form 10-K for the year ended December 31, 2013. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.
Celebrex® is a registered trademark of Pfizer, Inc.
SOURCE Actavis plc