Navigation Links
Watson Confirms AVODART(R) Patent Challenge
Date:6/20/2011

PARSIPPANY, N.J., June 20, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. – Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Dutasteride Capsules, 0.5 mg.  Watson's Dutasteride Capsules product is a generic version of GlaxoSmithKline's AVODART(R), which is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

GlaxoSmithKline LLC filed suit against Watson on June 17, 2011 in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its Dutasteride Capsules product prior to the expiration of U.S. Patent No. 5,565,467. GlaxoSmithKline's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA until November 17, 2013 or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

For the twelve months ending April 30, 2011, AVODART had total U.S. sales of approximately $580 million according to IMS Health data.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc. is an integrated 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 or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; 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 quarterly report on form 10-Q for the quarter ended March 31, 2011 and Watson's annual report on Form 10-K for the year ended December 31, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.  

AVODART(R) is a registered trademark of GlaxoSmithKline LLC.

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

CONTACTS:
Investors:
Patty Eisenhaur
(862) 261-8141
Media:
Charlie Mayr
(862) 261-8030


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

Related medicine technology :

1. Watson Confirms Court Decision Rejecting Tevas Motion to Prevent Launch of Generic SEASONIQUE®
2. Watsons Nabumetone Tablets Receive FDA Approval
3. Watson Confirms Pataday™ Patent Challenge
4. Watson Confirms Viagra® Patent Challenge
5. Watson to Present at the Goldman Sachs 32nd Annual Global Healthcare Conference
6. Watson Launches Generic AMRIX®
7. Watson Launches Generic Concerta®
8. Watson Pharmaceuticals to Webcast Annual Meeting of Stockholders on May 13th
9. Watson First Quarter 2011 Net Revenue Increases to $877 Million
10. New Life Agency Adds Watson to Join Walgreens on The Fertility Pharmacy Care Card for Fertility Medication
11. Watson Confirms Welchol® Patent Challenge
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... JOLLA, Calif. , Feb. 23, 2017 ... company leading the discovery and development of innovative medicines ... and full year 2016 financial results on Thursday, March ... will host a conference call and webcast on March ... fourth quarter and full year 2016 financial results and ...
(Date:2/23/2017)... -- ... Research and Markets has announced the addition of the "Global Antifungal ... to their offering. The Global Antifungal Drugs Market is ... decade to reach approximately $12.8 billion by 2025. ... given segments on global as well as regional levels presented in the ...
(Date:2/23/2017)... Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company ... and market advanced products and therapies for the Wound ... sectors of healthcare, today announced its record results for ... 2016. Full Year 2016 Highlights are: ... full year 2015 revenue ...
Breaking Medicine Technology:
(Date:2/23/2017)... ... February 23, 2017 , ... ... host a diverse symposium on “Doping in Sport: How the Culture Might ... Richter & Hampton LLP. The symposium will be held at Pepperdine University in ...
(Date:2/23/2017)... ... February 23, 2017 , ... ... in clinical trials, today announced that Premier Research, a leading clinical development service ... Clinical trials are becoming increasingly complex, due in part to an array of ...
(Date:2/23/2017)... ... February 23, 2017 , ... The ... the Rhode Island Consortium for Autism Research and Treatment (RI-CART) and Cinemaworld to ... autism spectrum disorder (ASD) to see films in an environment that accommodates their ...
(Date:2/23/2017)... Los Angeles, CA (PRWEB) , ... February 23, 2017 , ... ... of her Smiling Patriot program today with a new Indiegogo campaign ... dental care to homeless veterans in the Los Angeles area, either as a participating ...
(Date:2/23/2017)... (PRWEB) , ... February 23, 2017 , ... Thomas ... perseverance and disciplined exercise regime, the author was able to successfully recover. In “ ... all relevant information for various sources on the principals of massage, anatomy , ...
Breaking Medicine News(10 mins):