Navigation Links
Watson Confirms Renvela® Patent Challenge
Date:5/25/2010

MORRISTOWN, N.J., May 25 /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 800mg tablets.  Watson's sevelamer carbonate tablet is the generic version of Genzyme's Renvela®.  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 May 24, 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.  

For the twelve months ending March 31, 2010, Renvela ® had total U.S. sales of approximately $200 million according to IMS Health data.

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.

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 affecting Watson's business. These factors include, among others, 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.

(Logo: http://www.newscom.com/cgi-bin/prnh/20100121/LA41294LOGO )


'/>"/>
SOURCE Watson Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Watson to Present at the Bear Stearns 20th Annual Healthcare Conference
2. Watson Receives FDA Approval for Generic Accuneb(R)
3. Warner Chilcott and Watson Pharmaceuticals Announce Launch of Tilia(TM) Fe
4. Watson to Present at the 2008 Merrill Lynch Global Pharmaceutical, Biotechnology and Medical Device Conference
5. Watson Pharmaceuticals Reports Fourth Quarter and Full Year 2007 Results; Provides 2008 Outlook
6. Barr Subsidiary Sues Watson for SEASONIQUE(R) Patent Infringement
7. Watson Files FDA Application for Generic LYBREL(R)
8. FDA Approves MIXJECT(TM), a Convenient, Easy-to-Use Drug Delivery System For Watson Pharmaceuticals TRELSTAR(R) DEPOT and TRELSTAR(R) LA
9. Cephalon Files Patent Infringement Lawsuit Against Watson Pharmaceuticals
10. Watson Pharmaceuticals Reports Second Quarter 2008 Results
11. Watsons GELNIQUE(TM) (oxybutynin chloride) Gel 10% Approved by FDA for the Treatment of Overactive Bladder
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/15/2017)... ... ... Kapstone Medical is proud to announce that it has reached a ... develop and safeguard their latest innovations. The company has grown from a boutique ... in the United States and around the world. , Company Founder and President, ...
(Date:8/15/2017)... ... 2017 , ... Any expert in stem cell research or stem cell medicine ... half a century. Despite their essential roles in human health and regenerative medicine, ... tags developed for this purpose also tag other, more abundant, non-stem tissue cells ( ...
(Date:8/15/2017)... ... August 15, 2017 , ... ... by various biotic and abiotic factors. During this educational webinar, participants will learn ... as well as gain a better understanding of how genomics is important for ...
(Date:8/14/2017)... ... August 14, 2017 , ... Opal ... using USB or PCI Express, announced the release of SYZYGY™, a new open ... satisfy the need for a compact, low cost, low pin-count, high-performance connectivity solution ...
Breaking Biology Technology:
(Date:4/5/2017)... -- Today HYPR Corp. , leading innovator in ... the HYPR platform is officially FIDO® Certified . ... that empowers biometric authentication across Fortune 500 enterprises and ... 15 million users across the financial services industry, however ... suites and physical access represent a growing portion of ...
(Date:4/3/2017)... , April 3, 2017  Data captured ... engineering platform, detected a statistically significant association ... prior to treatment and objective response of ... potential to predict whether cancer patients will ... treatment, as well as to improve both pre-infusion ...
(Date:3/30/2017)... YORK , March 30, 2017 Trends, ... type (physiological and behavioral), by technology (fingerprint, AFIS, iris ... voice recognition, and others), by end use industry (government ... and immigration, financial and banking, and others), and by ... Europe , Asia Pacific , ...
Breaking Biology News(10 mins):