CORONA, Calif., June 2 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has received final approval from the U.S. Food and Drug Administration (“FDA”) of its Abbreviated New Drug Application (ANDA) for Omeprazole Delayed-Release Capsules USP in the 10mg, 20mg and 40mg strengths.
Watson has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for the 40mg strength. Watson’s marketing exclusivity will begin upon commercial launch. The Company plans to launch its Omeprazole Delayed-Release product during the third quarter of 2008. The specific launch date will depend upon the timing of product validation activities and manufacturing of launch quantities. Watson plans to launch only the 40 mg strength.
Omeprazole is the generic equivalent to AstraZeneca’s Prilosec(R) Delayed-Release Capsules USP and is indicated for the short-term treatment of active duodenal ulcer. For the 12-months ending March 2008, Prilosec(R) Delayed-Release Capsules and its generic equivalents had total U.S. sales of approximately $240 million, according to IMS Health.
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.watson.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, difficulties or delays in manufacturing; the difficulty of predicting the timing and outcome of litigation; the impact of competitive products and pricing; market acceptance of and continued demand for Watson’s products; 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, 2007.
Prilosec(R) is a registered trademark of the AstraZeneca group of companies.
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CONTACT: Patty Eisenhaur, Watson Pharmaceuticals, Inc., +1-951-493-5611
Web site: http://www.watsonpharm.com/
