CORONA, Calif., Jan. 30 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for testosterone gel 1% CIII. Testosterone gel 1% CIII is the generic equivalent to Solvay Pharmaceutical’s AndroGel(R), which is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. For the 12-months ending November 2005, Androgel 1% CIII had total U.S. sales of approximately $330 million, according to IMS Health data.
Watson has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for the product. Watson’s market exclusivity will begin upon the earlier of a commercial launch or a final court decision concerning pending litigation between Watson and Unimed Pharmaceuticals, a division of Solvay Pharmaceuticals.
Watson is currently involved in patent litigation on this product in the U.S. District Court for the Northern District of Georgia. Unimed Pharmaceuticals brought suit against Watson in August 2003 as a result of Watson’s paragraph IV certification to U.S. Patent No. 6,503,894 which expires in August 2020.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses. For press releases and other company information, visit Watson Pharmaceuticals’ Web site at http://www.watsonpharm.com.
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, the impact of competitive products and pricing; market acceptance of and continued demand for Watson’s products; difficulties or delays in manufacturing; the uncertainties concerning the outcome of the litigation described in this press release and related costs, expenses and possible diversion of management’s time and attention arising from such litigation; 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, 2004 and Form 10-Q for the period ended September 30, 2005.
AndroGel(R) is a registered trademark of Solvay Pharmaceuticals, Inc.
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CONTACT: Patty Eisenhaur of Watson Pharmaceuticals, Inc., +1-951-493- 5611
Web site: http://www.watsonpharm.com//
