Healthcare Industry News: fentanyl buccal tablet
News Release - March 25, 2011
Watson Confirms District Court Ruling in Generic Fentora(R) Patent SuitMORRISTOWN, N.J., March 25, 2011 -- (Healthcare Sales & Marketing Network) -- Watson Pharmaceuticals, Inc. (NYSE:WPI ), today confirmed that the United States District Court for the District of Delaware has ruled that Watson's generic version of FentoraŽ (fentanyl buccal tablets C-II) infringes United States Patent No. 6,264,981 (the '981 Patent). The Company said that it was reviewing the court's decision and would evaluate all available options, including an appeal.
Watson's Abbreviated New Drug Application ("ANDA") for its generic version of FentoraŽ has been approved by the FDA.
In 2008, Cephalon sued Watson for patent infringement related to its generic version of FentoraŽ. On March 11, 2011, the United States District Court for the District of Delaware ruled that Watson's product does not infringe United States Patent Nos. 6,200,604 and 6,974,590 (the '604 and '590 Patents) and that the '604 and '590 Patents are invalid.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading integrated global specialty pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets.
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson's current perspective of existing information as of the date of this release. It is important to note that Watson's goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson's current expectations depending upon a number of factors, risks and uncertainties affecting Watson's business. These factors include, among others, ; the difficulty of predicting the timing and outcome of any appeal of the pending patent litigation; the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations; and such 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 31,2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
FentoraŽ is a registered trademark of Cima Labs, Inc., a subsidiary of Cephalon, Inc.
Source: Watson Pharmaceuticals
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.