CORONA, Calif., March 4 /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 (0.15 mg/0.03
mg) extended-cycle oral contraceptive product, prior to the expiration of
patents owned by Duramed Pharmaceuticals, Inc., a subsidiary of Barr
Pharmaceuticals, Inc. Watson's levonorgestrel and ethinyl estradiol product
is a generic version of Barr's SEASONIQUE(R).
On January 23, 2008 pursuant to the Hatch-Waxman Act, Watson notified
Barr that it had filed an ANDA with a paragraph IV certification with the
FDA for a generic version of SEASONIQUE(R) asserting that the SEASONIQUE(R)
patent is invalid or not infringed. Based on available information, Watson
believes it may be the first applicant to file an ANDA for SEASONIQUE(R)
and, should its product be approved, may be entitled to 180 days of generic
market exclusivity.
SEASONIQUE(R) is indicated for the prevention of pregnancy.
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.
SEASONIQUE(R) is a registered trademark of Duramed Pharmaceuticals,
Inc.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO)
SOURCE Watson Pharmaceuticals, Inc.
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Related links:
http://www.watsonpharm.com
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CONTACT:
Patty Eisenhaur of Watson Pharmaceuticals,
Inc., +1-951-493-5611
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