CORONA, Calif., March 4 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its levonorgestrel and ethinyl estradiol (0.15 mg/0.03 mg) extended-cycle oral contraceptive product, prior to the expiration of patents owned by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc. Watson’s levonorgestrel and ethinyl estradiol product is a generic version of Barr’s SEASONIQUE(R).
On January 23, 2008 pursuant to the Hatch-Waxman Act, Watson notified Barr that it had filed an ANDA with a paragraph IV certification with the FDA for a generic version of SEASONIQUE(R) asserting that the SEASONIQUE(R) patent is invalid or not infringed. Based on available information, Watson believes it may be the first applicant to file an ANDA for SEASONIQUE(R) and, should its product be approved, may be entitled to 180 days of generic market exclusivity.
SEASONIQUE(R) is indicated for the prevention of pregnancy.
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, patents and other intellectual property rights held by competitors and other third parties and the uncertainty of the outcome of litigation related to such patents and intellectual property rights; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; the impact of competitive products and pricing; market acceptance of and continued demand for Watson’s products; difficulties or delays in manufacturing; 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.
SEASONIQUE(R) is a registered trademark of Duramed Pharmaceuticals, Inc.
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CONTACT: Patty Eisenhaur of Watson Pharmaceuticals, Inc., +1-951-493-5611
Web site: http://www.watsonpharm.com/
