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Actavis Confirms District Court Ruling in Generic Lialda® Patent Suit


5/10/2013 9:30:14 AM

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PARSIPPANY, N.J., May 9, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT) today confirmed that the United States District Court for the Southern District of Florida has found United States Patent No. 6,773,720 (the '720 Patent) valid and infringed by Actavis' generic version of Shire's Lialda® (mesalamine extended-release tablets). Actavis is reviewing the court's decision and will evaluate all available options, including an appeal.

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. Actavis' Abbreviated New Drug Application ("ANDA") for its generic version of Lialda® is currently pending with the U.S. Food and Drug Administration (FDA).

About Actavis

Actavis, Inc. (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has global headquarters in Parsippany, New Jersey, USA.

Operating as Actavis Pharma, the Company develops, manufactures and markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries. Actavis Specialty Brands is the Company's global branded specialty pharmaceutical business, focused in the Urology and Women's Health therapeutic categories. Actavis Specialty Brands also has a portfolio of 5 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., the fourth-largest U.S. generic pharmaceutical product distributor in the United States.

For press release and other company information, visit Actavis' Web site at http://www.actavis.com.

Forward-Looking Statement

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 any appeals thereof; 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' Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 and Actavis' annual report on Form 10-K for the year ended December 31, 2012. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

Lialda® is a registered trademark of Giuliani International Ltd., Ireland.

CONTACTS:

Investors:


Lisa DeFrancesco


(862) 261-7152




Media:


Charlie Mayr


(862) 261-8030

(Logo: http://photos.prnewswire.com/prnh/20130124/NY47381LOGO )

SOURCE Actavis, Inc.



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