- Paragraph IV Litigation Underway -
MORRISTOWN, N.J., May 5 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its 1000 mg/20 mg form of niacin extended-release/simvastatin tablets. Watson's 1000 mg/20 mg niacin extended-release/simvastatin tablets are generic versions of Abbott's 1000 mg/20 mg form of SIMCOR®. SIMCOR ® is indicated for people who have unhealthy cholesterol levels when treatment with simvastatin alone or niacin extended-release alone is not enough, and when a diet low in saturated fat and cholesterol and other non-drug measures alone have not been successful.
Abbott Laboratories and Abbott Respiratory, LLC filed suit against Watson on May 4, 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 Nos. 6,080,428; 6,129,930; 6,406,715; 6,469,035; 6,676,967; 6,746,691; 6,818,229; and 7,011,848. Abbott's suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivity.
For the twelve months ending December 31, 2009, SIMCOR ® had total U.S. sales of approximately $88 million 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 affecting Watson's business. These factors include, among others, 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 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 for the year ended December 31,2009. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
SIMCOR ® is a registered trademark of Abbott Laboratories.
SOURCE Watson Pharmaceuticals, Inc.