PARSIPPANY, N.J., Aug. 23, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc., has received final approval from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for lidocaine topical patch 5%, the generic equivalent to Endo's Lidoderm®. Watson plans to launch the product in September of 2013 pursuant with its settlement agreement with Endo Pharmaceuticals Inc. and believes that under Hatch Waxman rules, it will be entitled to 180 days of marketing exclusivity.
On May 29, 2012, Watson announced it had entered into an agreement with Endo Pharmaceuticals Inc. and Teikoku Seiyaku Co., Ltd to settle all outstanding patent litigation related to Watson's generic version of Lidoderm®. The agreement allows Watson to launch its lidocaine topical patch 5% product on September 15, 2013.
For the twelve months ending June 30, 2012, Lidoderm® had total U.S. sales of approximately $1.2 billion according to IMS Health data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is an integrated global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. The Company is also developing biosimilar products in Women's Health and Oncology. Additionally, Watson distributes generic and branded pharmaceuticals through its Anda, Inc. distribution business. 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 impact of competitive products and pricing; risks that resolution of patent infringement litigation through settlement could result in investigations or actions by private parties or governmental agencies or authorities; 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; the inherent uncertainty of financial projections; 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2012 and Watson's Annual Report on Form 10-K for the year ended December 31, 2011. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
Lidoderm® is a registered trademark of Hind Health Care, Inc.
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SOURCE Watson Pharmaceuticals, Inc.