Paragraph IV Patent Challenge UnderwayCORONA, CA, Apr 21, 2008 (MARKET WIRE via COMTEX News Network) -- 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 YASMIN(R) (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.
Forward-Looking Statement
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.
YASMIN(R) is a registered trademark of Bayer HealthCare.
CONTACTS:
Watson Pharmaceuticals, Inc.
Patty Eisenhaur
(951) 493-5611
SOURCE: Watson Pharmaceuticals