Navigation Links
Watson Confirms Crestor® Patent Challenge
Date:10/27/2010

MORRISTOWN, N.J., Oct. 27 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed a new drug application under Section 505(b)(2) of the Federal Food and Drug Cosmetic Act (FFDCA) with the U.S. Food and Drug Administration (FDA) seeking approval to market rosuvastatin zinc 5, 10, 20 and 40 mg tablets.  Watson's rosuvastatin zinc tablets are a new salt version of AstraZeneca's Crestor ® tablets.  Crestor® is indicated, as an adjunct to diet, to lower LDL cholesterol, raise HDL cholesterol, and slow the progression of atherosclerosis.

AstraZeneca filed suit against Watson on October 26, 2010 in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. RE 37,314.  AstraZeneca's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's NDA until March 30, 2013 or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.  

For the twelve months ending June 30, 2010, Crestor ® had total U.S. sales of approximately $3.5 billion 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, risks and uncertainties affecting Watson's business. These factors include, among others, the difficulty of predicting the timing and outcome of the pending patent 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 June 30, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.

Crestor® is a registered trademark of IPR Pharmaceuticals, Inc.

(Logo: http://photos.prnewswire.com/prnh/20100121/LA41294LOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20100121/LA41294LOGO)CONTACTS:Investors:Patty Eisenhaur(973) 355-8141Media:Charlie Mayr(973) 355-8483
'/>"/>

SOURCE Watson Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Watsons Generic Version of Lotrel ® Receives FDA Approval
2. Watson to Host Conference Call and Webcast to Discuss Third Quarter 2010 Earnings
3. Watson Reaches Settlement with Endo Over Opana® ER
4. Watson Confirms Azilect® Patent Challenge
5. Watson to Present at the Jefferies 2010 Global SpecPharma & European Healthcare Conference
6. HRA Pharma and Watson Pharmaceuticals Expand Marketing Partnership for Novel Emergency Contraceptive to Canada
7. Watson to Present at the Bank of America/Merrill Lynch Global Healthcare Conference
8. Watsons Generic Yasmin® Receives FDA Approval
9. Watson Names Sigurdur Oli Olafsson Executive Vice President, Global Generics
10. Watson Promotes Robert Stewart to Executive Vice President, Global Operations
11. Watson Confirms Renvela® for Oral Suspension Patent Challenge
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 2016 The vast majority of dialysis patients ... Treatments are usually 3 times a week, with treatment ... travel time, equipment preparation and wait time.  This regimen ... for patients who are elderly and frail.  Many elderly ... rehabilitation centers for some duration of time. ...
(Date:6/23/2016)... June 23, 2016  Experian Health, the ... transforming the patient payment and care experience, ... new products and services that will enhance ... cycle offerings. These award-winning solutions will enable ... remain compliant in an ever-changing environment and ...
(Date:6/23/2016)...  The National Pharmaceutical Council (NPC) today announced ... research organization as its newest member.  ... president and chief scientific officer, Mallinckrodt Pharmaceuticals, will ... Board of Directors. ... us in support of our efforts to conduct ...
Breaking Medicine Technology:
(Date:6/27/2016)... , ... June 27, 2016 , ... ... mental health professionals, announced today its affiliation with Tennessee Counseling Association. ... to the network of the Tennessee Counseling Association, adding exclusive benefits and promotional ...
(Date:6/27/2016)... Park, KS (PRWEB) , ... June 27, 2016 , ... ... in retailers of Eyeglasses . , Millions of individuals in the United States ... eyeglasses have become a way to both correct vision and make a fashion statement. ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice ... "Film editors can give their videos a whole new perspective by using the ... of Pixel Film Studios. , ProSlice Levels contains over 30 Different presets to ...
(Date:6/26/2016)... , ... June 26, 2016 , ... ... once they have been diagnosed with endometriosis. These women need a treatment plan ... require a comprehensive approach that can help for preservation of fertility and ultimately ...
(Date:6/25/2016)... ... ... closing of Bruton Memorial Library on June 21 due to a possible lice infestation, as ... of head lice: the parasite’s ability to live away from a human host, and to ... one in the event that lice have simply gotten out of control. , As lice ...
Breaking Medicine News(10 mins):