Navigation Links
Watson Confirms Rapamune(R) Patent Challenge
Date:4/28/2010

MORRISTOWN, N.J., April 28 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, has been sued by Pfizer Inc. and Wyeth Pharmaceuticals Inc. in connection with the filing of Watson's Abbreviated New Drug Application (ANDA) for sirolimus tablets in the 1 mg and 2 mg strengths. Watson's ANDA is for a generic equivalent of Wyeth's Rapamune® tablets product. The suit was filed on April 28, 2010 in the United States District Court for the District of Delaware.

Pursuant to the Hatch-Waxman Act, Watson previously notified Pfizer and Wyeth that Watson's ANDA contains a paragraph IV certification asserting that U.S. Patent No. 5,100,899 is invalid, unenforceable and /or will not be infringed by the commercial manufacture, use or sale of the drug products described in Watson's ANDA.  Based on available information, Watson believes it may be a "first applicant" to file an ANDA for the 1 mg and 2 mg generic version of Rapamune® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity for those strengths.

Rapamune® (sirolimus) tablets are indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants.  For the twelve months ending February 2010, Rapamune® had total U.S. sales of approximately $210.5 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 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 for the year ended December 31,2009. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.

Rapamune® is a registered trademark of Pfizer Inc.

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


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

Related medicine technology :

1. Watson Confirms Cenestin(R) Patent Challenge
2. Watson Says Appeals Court Affirms Concerta(R) Patent Invalid
3. Watson to Present at Barclays 2010 Global Healthcare Conference
4. Watson Receives FDA Approval for Generic Cardizem(R) LA
5. FDA Approves Watsons TRELSTAR(R) 22.5 mg, the First and Only 6-Month Intramuscular GnRH Agonist for the Palliative Treatment of Advanced Prostate Cancer
6. Watson Announces Actos(R) Patent Challenge Settlement
7. Watson Confirms Filing of Generic Opana(R) ER Application
8. Watson Signs Agreement to Divest Equity Interest in ScinoPharm
9. Watson to Present at CLSA/Asia USA Investors Forum
10. Watson to Host Conference Call and Webcast to Discuss Fourth Quarter 2009 Earnings and 2010 Outlook
11. Watson Completes Acquisition of Eden Biodesign
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/9/2017)... PORTLAND, Ore. , May 9, 2017 /PRNewswire/ ... company that provides technology solutions to improve the ... reported financial results for the first quarter ended ... that our products enable our customers to identify ... them to intervene before events like heart attacks ...
(Date:5/6/2017)... , May 5, 2017  Hill-Rom Holdings, Inc. ... add approximately 100,000 square feet to its Welch Allyn ... 2016 its commitment to bring more than 100 new ... where Welch Allyn has maintained a significant presence for ... accommodate these new positions, a large portion of which ...
(Date:5/4/2017)... , May 4, 2017  DarioHealth Corp. (NASDAQ: ... health and big data solutions, today announced that it ... Company, and STI Technologies Limited to lower diabetes healthcare ... Through STI,s innoviCares card, which is available throughout all ... DarioHealth customers will be eligible for additional savings when ...
Breaking Medicine Technology:
(Date:5/23/2017)... ... 23, 2017 , ... i2i Population Health, a national leader ... winner, has named Daniel P. Bullington as chief technology officer. , “i2i is ... product offerings,” says Justin Neece, president. “Daniel is an excellent fit for our ...
(Date:5/23/2017)... ... May 23, 2017 , ... London, May 23, 2017: Walter Schindler, ... this month as a Guest Speaker and Contributor to a weeklong series of classes, ... Purpose. , Walter Schindler and SAIL Capital have received ...
(Date:5/23/2017)... Santa Rosa, CA (PRWEB) , ... May 23, 2017 , ... ... booming mosquito season underway in Sonoma County. While officials call for diligence, asking homeowners ... providers are looking at potential health concerns. Along with the annoying buzz of mosquitos ...
(Date:5/23/2017)... ... May 23, 2017 , ... MedTech For Solutions ... modern ART laboratory, to provide hands-on training utilizing cutting-edge equipment at its recently-opened ... a MedTech Group Purchasing vendor , will provide specialized equipment to ensure ...
(Date:5/23/2017)... ... ... New patients from Charleston, SC, are now welcome to receive a full ... with or without a referral. A full mouth reconstruction can transform the appearance of ... Charleston, SC. Those who suffer from gum disease, misaligned teeth or jaw pain can ...
Breaking Medicine News(10 mins):