PARSIPPANY, N.J., May 29, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc., has 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, if approved by the U.S. Food and Drug Administration (FDA). The license will be exclusive as to an authorized generic version of Lidoderm until the earlier of a third party generic launch or seven and one half months after Watson’s launch of its generic product. Endo will receive 25% of the gross profit generated on Watson’s sales of its generic version of Lidoderm® during Watson’s period of exclusivity.
Additionally, under the terms of the agreement, Watson will receive and be able to distribute equal amounts of branded Lidoderm® product from Endo valued at a total of up to approximately $96 million during the first eight months of 2013. In the event that Watson has not received FDA approval to launch its own lidocaine topical patch 5% by January 1, 2014, Watson will receive additional quantities of branded Lidoderm® product to distribute valued at up to approximately $80 million in 2014 over a period of twelve months and in the event that Watson has not received FDA approval to launch its own lidocaine topical patch 5% by January 1, 2015, up to approximately $64 million over a period of nine months in 2015. Watson’s availability of brand product would cease upon the launch of any generic version of Lidoderm®.
“The agreement provides a date certain launch of competition for Endo’s branded Lidoderm, eliminating any risks involving current pending or future patent litigation surrounding the product,” said Paul Bisaro, Watson’s President and CEO. “By entering into this agreement, Watson ensures that consumers may benefit from generic competition at least two years prior to the 2015 patent expiry on Lidoderm® assuming FDA approval. Additionally, consumers and Watson shareholders will benefit from the January 2013 distribution of select amounts of branded Lidoderm product. We remain confident in our ability to obtain final FDA approval of our generic version of Lidoderm prior to our agreed launch date.”
For the twelve months ending March 31, 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.
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 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; risks that resolution of patent infringement litigation through settlement could result in investigations or actions by private parties or government authorities or agencies; 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 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.
