MORRISTOWN, N.J., Oct. 27 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed a new drug application under Section 505(b)(2) of the Federal Food and Drug Cosmetic Act (FFDCA) with the U.S. Food and Drug Administration (FDA) seeking approval to market rosuvastatin zinc 5, 10, 20 and 40 mg tablets. Watson's rosuvastatin zinc tablets are a new salt version of AstraZeneca's Crestor ® tablets. Crestor® is indicated, as an adjunct to diet, to lower LDL cholesterol, raise HDL cholesterol, and slow the progression of atherosclerosis.
AstraZeneca filed suit against Watson on October 26, 2010 in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. RE 37,314. AstraZeneca's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's NDA until March 30, 2013 or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
For the twelve months ending June 30, 2010, Crestor ® had total U.S. sales of approximately $3.5 billion according to IMS Health data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets.
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
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 difficulty of predicting the timing and outcome of the pending patent litigation; 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 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 annual report on Form 10-K for the year ended December 31,2009 and Watson's quarterly report on Form 10-Q for the period ended June 30, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
Crestor® is a registered trademark of IPR Pharmaceuticals, Inc.
SOURCE Watson Pharmaceuticals, Inc.