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Watson Pharmaceuticals, Inc. confirmed that its subsidiary Watson Laboratories, Inc. has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market its Fentanyl Buccal Tablets C-II product prior to the expiration of patents owned by Cephalon
CORONA, CA, USA | April 24, 2008 | Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today confirmed that its subsidiary Watson Laboratories, Inc. (a Nevada Corporation) has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its Fentanyl Buccal Tablets C-II product prior to the expiration of patents owned by Cephalon, Inc. Watson's Fentanyl Buccal Tablets C-II product is a generic version of Cephalon's FENTORA(R) C-II (fentanyl buccal tablet) which is indicated only for the treatment of breakthrough pain in opioid tolerant patients with cancer.
In its Notice Letter to Cephalon, Watson contends that U.S. Patent Numbers 6,200,604 and 6,974,590 are invalid, unenforceable and/or will not be infringed by Watson's manufacture, use or sale of the product described in its ANDA. Based on available information, Watson believes it may be the first applicant to file an ANDA for FENTORA(R) containing a paragraph IV certification under the provisions of the Hatch-Waxman Act and, should its product be approved, may be entitled to 180 days of generic market exclusivity.
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.
FENTORA(R) is a registered trademark of Cima Labs, Inc., a subsidiary of Cephalon, Inc.
SOURCE: Watson Pharmaceuticals, Inc.
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