Navigation Links
Watson Confirms JALYN™ Patent Challenge

PARSIPPANY, N.J., July 22, 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 and tamsulosin hydrochloride capsules. Watson's dutasteride and tamsulosin hydrochloride capsules are a generic version of GlaxoSmithKline's JALYN™. JALYN™ capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.


GlaxoSmithKline filed suit against Watson on July 21, 2011 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. 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 December 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 May 31, 2011, JALYN™ capsules had total U.S. sales of over $30 million according to IMS Health data.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc. is a leading integrated global pharmaceutical company. The Company is engaged in the development 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

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.

JALYN™ is a trademark of GlaxoSmithKline.


Patty Eisenhaur
(862) 261-8141

Charlie Mayr
(862) 261-8030

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

Related medicine technology :

1. Watson Confirms Favorable Appeals Court Decision in Mucinex(R) Patent Suit
2. Watson Confirms Vyvanse® Patent Challenge
3. Watson to Host Conference Call and Webcast to Discuss Second Quarter 2011 Earnings
4. Watson Announces Expansion of Salt Lake City, Utah Pharmaceutical R&D and Manufacturing Facility
5. Watson to Present at 2011 Wells Fargo Securities Healthcare Conference
6. Watson Confirms AVODART(R) Patent Challenge
7. Watson Confirms Court Decision Rejecting Tevas Motion to Prevent Launch of Generic SEASONIQUE®
8. Watsons Nabumetone Tablets Receive FDA Approval
9. Watson Confirms Pataday™ Patent Challenge
10. Watson Confirms Viagra® Patent Challenge
11. Watson to Present at the Goldman Sachs 32nd Annual Global Healthcare Conference
Post Your Comments:
(Date:11/26/2015)... --> --> Juntendo University Hospital ... weighting of MRI for patients with Multiple Sclerosis (MS) ... with SyntheticMR in order to use SyMRI in clinical research ... generate multiple contrast images from a single scan and adjust ... it possible to both fine tune images and recreate additional ...
(Date:11/26/2015)... November 26, 2015 ... the "2016 Future Horizons and Growth ... Testing Market: Supplier Shares, Country Segment Forecasts, ... their offering. --> ) ... "2016 Future Horizons and Growth Strategies in ...
(Date:11/26/2015)... Research and Markets ( ) has announced the ... Type (Dressings, Therapy Devices, Active Wound Care), Application (Surgical ... Geography - Global Forecast to 2020" report to ... --> The purpose of this report is to ... advanced wound care market. It involves deep dive analysis ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... 28, 2015 , ... There is only one major question facing all law ... , This question has not been an easy question to answer. Especially when the ... the younger workforce don’t share the same discipline around working long hours. , ...
(Date:11/27/2015)... ... 27, 2015 , ... A team of Swiss doctors has released a report ... has just posted the findings on the website. Click here to read the ... 136 mesothelioma patients who were treated with chemotherapy followed by EPP surgery. Among the ...
(Date:11/27/2015)... CA (PRWEB) , ... November 27, 2015 , ... ... use in Final Cut Pro X. With ProSidebar: Fasion, video editors can easily ... use ProSidebar as a minimalist title opener. Utilize presets featuring self-animating drop zones, ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... Consultants has prided itself for not only fulfilling the needs of advisers and ... at an affordable price and providing top-tier customer service. However, there's always room ...
(Date:11/27/2015)... Francisco, California (PRWEB) , ... November 27, 2015 , ... ... Janis Joplin Ann Arbor Michigan boxing style concert posters. This is one of Joplin's ... at the Canterbury House at the University of Michigan in Ann Arbor. The According ...
Breaking Medicine News(10 mins):