Watson Confirms Beyaz(R) Patent Challenge
- Paragraph IV Litigation Underway -
PARSIPPANY, N.J., Feb. 10, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Drospirenone and Ethinyl Estradiol and Levomefolate Calcium Tablets, 3.0 mg/0.02 mg/0.451 mg and Levomefolate Calcium Tablets, 0.451 mg. Watson's ANDA product is a generic version of Bayer HealthCare Pharmaceuticals Inc.'s Beyaz®. Beyaz® is an oral contraceptive indicated for use by women to prevent pregnancy, treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception, treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control, and raise folate levels in women who choose to use an oral contraceptive for contraception.
Bayer HealthCare Pharmaceuticals Inc., Bayer Pharma AG, and Merck & Cie filed suit against Watson on February 10, 2012, 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. 6,441,168. The lawsuit 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 from the date the plaintiffs received notice of Watson's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Based on available information, Watson believes it may be a "first applicant" to file an ANDA for the generic version of Beyaz® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the twelve months ending December 31, 2011, Beyaz® had total U.S. sales of approximately $97 million according to IMS Health data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading integrated global 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, risks and uncertainties affecting Watson's business. These factors include, among others, the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; 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 quarterly report on form 10-Q for the quarter ended September 30, 2011 and Watson's annual report on Form 10-K for the year ended December 31, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
Beyaz® is a registered trademark of Bayer Aktiengesellschaft.
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