MORRISTOWN, N.J., Jan. 10, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for Fentanyl Buccal tablets, USP, in the 0.1, 0.2, 0.4, 0.6 and 0.8 mg strengths, the generic equivalent to Cephalon's Fentora ® tablets.
Watson's Abbreviated New Drug Application (ANDA) for its generic version of FENTORA® is the first generic application approved by FDA, and as such, may be entitled to a 180-day period of market exclusivity. FDA will make a formal determination concerning Watson's entitlement to market exclusivity only in the event another Paragraph IV ANDA becomes eligible for final approval prior to 180 days after Watson's product launch or the expiration of listed Orange Book patents. A decision on Cephalon's lawsuit alleging that Watson's product infringes various Cephalon patents remains pending in the U.S. District Court for the District of Delaware. Watson is currently enjoined from launching its product until a decision is rendered.
Fentora ® had total U.S. sales of approximately $179 million for the twelve months ending November 30, 2010, according to IMS Health. Fentanyl Buccal tablets are indicated to treat breakthrough pain in adult patients with cancer (18 years of age and older) who are regularly using other opioid pain medicines around-the-clock for their constant cancer pain.
About Watson Pharmaceuticals, Inc.Watson Pharmaceuticals, Inc. is a leading 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.
Forward-Looking Statement 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 the pending patent litigation and risks that an adverse outcome in such litigation could prevent Watson from launching its product prior to the expiration of the patents in suit; risks that a product launch prior to a final decision in the litigation in Watson's favor could render Watson liable for substantial damages; 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, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; 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 31,2009 and Watson's quarterly report on Form 10-Q for the period ended September 30, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
Fentora® is a registered trademark of Cima Labs, Inc., a subsidiary of Cephalon, Inc.
(Logo: http://photos.prnewswire.com/prnh/20100121/LA41294LOGO ) CONTACTS:Investors:Patty EisenhaurWatson Pharmaceuticals, Inc.(973) 355-8141Media:Charlie MayrWatson Pharmaceuticals, Inc.(973) 355-8483
|SOURCE Watson Pharmaceuticals, Inc.|
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