Navigation Links
Watson Confirms BYSTOLIC(R) Patent Challenge
Date:3/14/2012

PARSIPPANY, N.J., March 14, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Nebivolol Hydrochloride Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg. Watson's ANDA product is a generic version of Forest Laboratories' BYSTOLIC®, which is a beta-adrenergic blocking agent that is approved for the treatment of hypertension.

Forest Laboratories filed suit against Watson on March 13, 2012, 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. 6,545,040.  The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA until June 17, 2015 or final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Based on available information, Watson believes it may be a "first applicant" to file an ANDA for the generic version of BYSTOLIC® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

For the twelve months ending January 31, 2012, BYSTOLIC® had total U.S. sales of approximately $391 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 annual report on Form 10-K for the year ended December 31, 2011. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.

BYSTOLIC® is a registered trademark of Forest Laboratories, Inc.  

(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 Launches Generic PROMETRIUM(R)
2. Watson to Present at the Barclays Capital 2012 Global Healthcare Conference
3. Watson Receives Complete Response Letter from FDA for Progesterone Vaginal Gel 8%
4. Watson to Present at the 2012 RBC Capital Markets Healthcare Conference
5. Watson to Present at the Citi 2012 Global Healthcare Conference
6. Watson Full Year 2011 Net Revenue Increases 29% to $4.58 Billion;
7. Watson Provides Update on Generic Lidoderm® Application
8. Watson Reaches Settlement with Mallinckrodt Over Exalgo(R)
9. Watson Confirms Court Stays Preliminary Injunction
10. Watson Announces Preliminary 2011 Non-GAAP Earnings of $4.75-$4.77
11. Watson Acquires Ascent Pharmahealth for AU$375 Million
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/9/2017)... , May 9, 2017  Oramed Pharmaceuticals Inc. ... a clinical-stage pharmaceutical company focused on the development ... the Canadian Intellectual Property Office has granted Oramed ... Administration of Exenatide". The patent covers Oramed,s invention ... GLP-1 is an incretin hormone that stimulates ...
(Date:5/6/2017)... Provista , a proven leader in the supply chain industry ... Jim Cunniff as the company,s new president and CEO. ... Provista, including most recently serving as the president and CEO ... He assumed his new role with Provista on May 1, ... says Jody Hatcher , president, Sourcing and Collaboration Services ...
(Date:5/4/2017)... MEMPHIS, Tenn. , May 4, 2017 /PRNewswire/ ... of Infection Control, Ultraviolet-C light as ... demonstrated Tru-D SmartUVC,s ability to reduce bioburden on ... influenced bioburden reduction on high-touch, complex medical equipment ... in surgical infections. "This study further ...
Breaking Medicine Technology:
(Date:5/24/2017)... ... 2017 , ... The CFOs included on this list lead ... the nation and help their organizations navigate the challenges in healthcare today. These ... developing successful hospital and health system strategy. , Becker's Hospital Review has published ...
(Date:5/24/2017)... (PRWEB) , ... May 24, 2017 , ... Technique, technique, ... back injury when either lifting weights for strength training and exercise or simply lifting ... Center . , “Body position is everything,” Dr. Chang says. “Improper technique in lifting ...
(Date:5/23/2017)... ... May 23, 2017 , ... MDLand ... Integration company, announced today that its iClinic V12.2 solution has achieved approval from ... NCQA recently introduced PCMH 2017 standards which emphasize team-based care with a significant ...
(Date:5/23/2017)... ... ... Allegheny Health Network and the Alexis Joy D’Achille Foundation ... at West Penn Hospital , a unique facility that will offer the most ... Construction of the Center is underway with a scheduled opening in the fall of ...
(Date:5/23/2017)... ... May 23, 2017 , ... Cambridge, MA, May 23, 2017—Total ... according to a Workers Compensation Research Institute (WCRI) study, a contrast from the ... System: CompScope™ Benchmarks, 17th Edition looks at indemnity and medical payments for ...
Breaking Medicine News(10 mins):