PARSIPPANY, N.J., Jan. 23, 2013 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that Actavis South Atlantic LLC, which was acquired by Watson in October, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Oxymorphone Hydrochloride Extended-release Tablets. Actavis' ANDA product is a generic version of the currently marketed formulation of Endo Health Solutions' Opana® ER, which is an opioid agonist indicated for the relief of moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an extended period of time.
Endo and Grunenthal GmbH filed suit against Actavis on January 18, 2013, in the U.S. District Court for the Southern District of New York seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
For the 12 months ending November 30, 2012, Opana® ER had total U.S. sales of approximately $512 million according to IMS Health data.
About Watson Pharmaceuticals, Inc. Watson Pharmaceuticals, Inc. (NYSE: WPI) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has global and U.S. headquarters in Parsippany, New Jersey, USA, and international headquarters in Zug, Switzerland.
Watson is the world's third-largest generics prescription drug manufacturer, with more than 750 products marketed globally through operations in more than 60 countries. Watson's global branded pharmaceutical business develops and markets products principally in Urology and Women's Health, and is committed to developing and marketing biosimilars products in Women's Health, Oncology and other therapeutic categories. In addition, Watson is the fourth-largest U.S. generic pharmaceutical product distributor through its Anda, Inc. business, and also develops and out-licenses generic pharmaceutical products outside of the U.S. through its Medis third-party business. Watson has announced that it will adopt a new global name – Actavis – effective in 2013.
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
Forward-Looking Statement Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson's current perspective of existing information as of the date of this release. It is important to note that Watson's goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson's current expectations depending upon a number of factors, risks and uncertainties affecting Watson's business. These factors include, among others, the impact of competitive products and pricing; the timing and success of product launches; difficulties predicting the timing our outcome of product development efforts and regulatory agency approvals or actions, if any; 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 Watson and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 and Watson's Annual Report on Form 10-K for the year ended December 31, 2011. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
Opana® is a registered trademark of Endo Pharmaceuticals, Inc.
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SOURCE Watson Pharmaceuticals, Inc.