- Paragraph IV Patent Challenge Underway -
CORONA, Calif., March 13 /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 its
Levonorgestrel and Ethinyl Estradiol tablets, USP (0.09 mg/0.02 mg)
extended-cycle oral contraceptive product prior to the expiration of patents
owned by Wyeth. Watson's Levonorgestrel and Ethinyl Estradiol product is a
generic version of Wyeth's LYBREL(R) (levonorgestrel and ethinyl estradiol)
tablets which is indicated for the prevention of pregnancy.
Wyeth filed suit against Watson on March 12, 2008 in the U.S. District
Court, District of Delaware, seeking to prevent Watson from commercializing
its product prior to the expiration of U.S. patent number 6,500,814. Wyeth'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. Based on
available information, Watson believes it may be the first applicant to file
an ANDA for LYBREL(R) and, should its product be approved, may be entitled to
180 days of generic market exclusivity.
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.
Lybrel(R) is a registered trademark of Wyeth.
SOURCE Watson Pharmaceuticals, Inc.
CONTACT: Patty Eisenhaur of Watson Pharmaceuticals, Inc.,
Web site: http://www.watsonpharm.com