- Paragraph IV Patent Challenge Underway -
CORONA, Calif., Nov. 7 /PRNewswire-FirstCall/ -- 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.
CONTACT: Patty Eisenhaur of Watson Pharmaceuticals, Inc.,
Web site: http://www.watsonpharm.com