Watson Files FDA Application for Generic YASMINÂ®
Paragraph IV Patent Challenge Underway
Watson PharmaceuticalsCORONA, CA--(Marketwire - April 21, 2008) - Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its Drospirenone and Ethinyl Estradiol tablets (3.00 mg/0.03 mg) combination oral contraceptive product prior to the expiration of patents owned by Bayer HealthCare Pharmaceuticals, Inc. (Bayer). Watson's Drospirenone and Ethinyl Estradiol product is a generic version of Bayer's YASMINÂ® (drospirenone and ethinyl estradiol) tablet which is indicated for the prevention of pregnancy.
Bayer filed suit against Watson on April 18, 2008 in the U.S. District Court, District of Southern New York seeking to prevent Watson from commercializing its product prior to the expiration of U.S. patent number 5,569,652. Bayer'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.
Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. 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, patents and other intellectual property rights held by competitors and other third parties and the uncertainty of the outcome of litigation related to such patents and intellectual property rights; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; the impact of competitive products and pricing; market acceptance of and continued demand for Watson's products; difficulties or delays in manufacturing; and 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, 2007.