Watson Files FDA Application for Generic YAZ(R)
- Paragraph IV Patent Challenge Underway -
CORONA, Calif., Nov. 7 -- 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 a generic version of YAZ(R) tablets prior to the expiration of patents owned by Bayer Schering Pharma AG and Bayer Healthcare Pharmaceuticals Inc. (Bayer). Bayer filed suit against Watson on November 5, 2007 in the U.S. District Court, District of Nevada, seeking to prevent Watson from commercializing its product prior to the expiration of patents numbered 6,787,531, RE 37,564 and RE 37,838. Bayer's suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of FDA approval of Watson's ANDA for 30 months or until final resolution of the matter before the court, whichever occurs sooner.
YAZ(R) (drosperinone and ethinyl estradiol tablets) is indicated for the prevention of pregnancy.
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 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, 2006.
YAZ(R) is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc.
SOURCE Watson Pharmaceuticals, Inc.