MORRISTOWN, N.J., April 26 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., a Nevada Corporation, has been sued by Teva Women's Health, Inc., in connection with the filing of Watson's Abbreviated New Drug Application (ANDA) for synthetic conjugated estrogens, A, in the 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg tablet strengths. Watson's ANDA is for the generic equivalent of Teva's Cenestin®. The suit was filed on April 23, 2010, in the United States District Court for the District of New Jersey.
Pursuant to the Hatch-Waxman Act, Watson previously notified Teva Women's Health that Watson's ANDA contains a paragraph IV certification asserting that U.S. Patent No. 5,908,638 is invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the drug products described in Watson's ANDA.
Cenestin® (synthetic conjugated estrogens, A) Tablets are for use by women after menopause to reduce hot flashes and treat dryness, itching, and burning in and around the vagina. For the twelve months ending December 31, 2009, Cenestin® had total U.S. sales of approximately $35 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 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 on Form 10-K 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.
Cenestin® is a registered trademark of Teva Women's Health. Inc.
|SOURCE Watson Pharmaceuticals, Inc.|
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