- Paragraph IV Litigation Underway -
MORRISTOWN, N.J., July 12 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market sevelamer carbonate for oral suspension, 0.8g and 2.4g per packet. Watson's sevelamer carbonate for oral suspension product is the generic version of Genzyme's Renvela® for Oral Suspension. Renvela ® is a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease who are on dialysis.
Genzyme Corporation filed suit against Watson on July 9, 2010 in the United States District Court for the District of Maryland seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 5,667,775. Genzyme's suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities. Based on available information, Watson believes it may be a first applicant to file an ANDA requesting approval of a generic version of Renvela® for oral suspension, and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity for this dosage form.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading 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. 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 affecting Watson's business. These factors include, among others, the difficulty of predicting the timing or outcome of product development efforts and FDA approvals or actions, if any; the difficulty of predicting the timing or outcome of litigation; the impact of competitive products and pricing; 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; 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 annual report on Form 10-K for the year ended December 31, 2009 and Watson's quarterly report on Form 10-Q for the period ended March 31, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
Renvela® is a registered trademark of Genzyme Corporation.
SOURCE Watson Pharmaceuticals, Inc.