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Wyeth filed suit against Watson on March 12, 2008 in the U.S. DistrictCourt, District of Delaware, seeking to prevent Watson from commercializingits product prior to the expiration of U.S. patent number 6,500,814. Wyeth'ssuit was filed under the provisions of the Hatch Waxman Act, resulting in astay of final FDA approval of Watson's ANDA for up to 30 months or until finalresolution of the matter before the court, whichever occurs sooner. Based onavailable information, Watson believes it may be the first applicant to filean ANDA for LYBREL(R) and, should its product be approved, may be entitled to180 days of generic market exclusivity.
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Forward-Looking Statement
Any statements contained in this press release that refer to future eventsor other non-historical facts are forward-looking statements that reflectWatson's current perspective of existing trends and information as of the dateof this release. Except as expressly required by law, Watson disclaims anyintent or obligation to update these forward-looking statements. Actualresults may differ materially from Watson's current expectations dependingupon a number of factors affecting Watson's business. These factors include,among others, patents and other intellectual property rights held bycompetitors and other third parties and the uncertainty of the outcome oflitigation related to such patents and intellectual property rights; thedifficulty of predicting the timing or outcome of product development effortsand FDA or other regulatory agency approvals or actions; the impact ofcompetitive products and pricing; market acceptance of and continued demandfor Watson's products; difficulties or delays in manufacturing; and otherrisks and uncertainties detailed in Watson's periodic public filings with theSecurities and Exchange Commission, including but not limited to Watson'sAnnual Report on Form 10-K for the year ended December 31, 2007.Lybrel(R) is a registered trademark of Wyeth.
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SOURCE Watson Pharmaceuticals, Inc.
