DUBLIN, March 28, 2014 /PRNewswire/ -- Actavis plc (ACT) today confirmed that the United States Court of Appeals for the Federal Circuit has reversed a lower court ruling that Actavis' generic version of Shire's Lialda® (mesalamine extended-release tablets) infringes United States Patent No. 6,773,720 (the '720 Patent).
The Appeals Court found that the U.S. District Court for the Southern District of Florida did not correctly construe the claims of the '720 Patent, and remanded the case to the District Court for further proceedings using claim constructions consistent with the Appeals Court's ruling.
Actavis' Abbreviated New Drug Application for its generic version of Lialda® is currently pending with the U.S. Food and Drug Administration (FDA).
Lialda® is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC. For the 12 months ended January 31, 2014 total U.S. sales of Lialda® were approximately $576 million, according to IMS Health.
Actavis plc (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.
Lialda® is a registered trademark of Nogra Pharma Limited, Ireland.
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