CORONA, Calif., Oct. 1 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , 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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