Navigation Links
Watson Confirms JALYN™ Patent Challenge
Date:7/22/2011

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.

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

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 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.

JALYN™ is a trademark of GlaxoSmithKline.

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 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:
*Name:
*Comment:
*Email:
(Date:5/12/2017)... , May 12, 2017  The China and Canada ... technology that consumes less water, energy and detergent, and features a ... product LaughingU, a shoebox-sized washing machine that washes and sanitizes women,s ... ... LaughingU, is compact, and does not require an external water inlet. ...
(Date:5/10/2017)... BARRINGTON, Ill. , May 10, 2017 ... medicine today; unfortunately its costs have also spiraled to ... are being sent to radiology than ever before as ... and diagnosis.  For a patient with lower back pain ... prove no anatomical reason for pain, resulting in entirely ...
(Date:5/9/2017)... 9, 2017  Semler Scientific, Inc. (OTCQB: SMLR), ... to improve the clinical effectiveness and efficiency of ... first quarter ended March 31, 2017. ... customers to identify when preventive care options are ... like heart attacks or strokes occur," said ...
Breaking Medicine Technology:
(Date:5/24/2017)... Linda, Ca (PRWEB) , ... May 24, 2017 ... ... between effects and background. Understanind and choosing the most appropriate instruments for research ... prove critical in research finding. This webinar will focus on innovations in stereo ...
(Date:5/24/2017)... ... , ... Dr. Manju R. Kejriwal, a leading Ohio dentist, is now welcoming ... referral. Dr. Kejriwal understands the emotional and financial toll traditional orthodontics can take on ... no longer need to feel the esthetic effects of wires and brackets when they ...
(Date:5/24/2017)... Michigan (PRWEB) , ... May ... ... disease affecting the female reproductive tract in which the endometrial lining of ... structures causing inflammation and pain. Patients experiencing painful intercourse, painful periods, pelvic ...
(Date:5/24/2017)... ... 2017 , ... Rob Lowe is a sought after actor, and also serves ... the public important topics from all aspects of life, and a new segment is ... feet and ankles. , Podiatry is essential to people’s overall well-being, and if viewers ...
(Date:5/23/2017)... ... May 23, 2017 , ... ... and Clinical Integration company, announced today that its iClinic V12.2 solution has achieved ... Prevalidation. NCQA recently introduced PCMH 2017 standards which emphasize team-based care with ...
Breaking Medicine News(10 mins):