CORONA, Calif., Oct. 1 CA-Watson-Pharmaceut
CORONA, Calif., Oct. 1 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals,
Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today confirmed
the receipt of a Paragraph IV Certification Notice Letter relating to an
Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug
Administration (FDA) by a generic filer requesting approval to market and sell
a generic version of OYXTROL(R) (Oxybutynin Transdermal System). In its Notice
Letter, the filer alleges that patents covering OXYTROL are invalid,
unenforceable and/or will not be infringed by their manufacture, use or sale
of the product described in its ANDA.
Watson currently is reviewing the Notice Letter and, by statute, has 45
days to initiate a patent infringement lawsuit against the filer. Such a
lawsuit would automatically prevent the FDA from approving the ANDA until the
earlier of a district court decision or 30 months from Watson's receipt of the
Notice Letter.
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 Watson
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.
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SOURCE Watson Pharmaceuticals, Inc.
