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:3/24/2017)... 23, 2017  HealthMine surveys with 9,250 insured consumers ... health plan members want help from their plans in ... in their health, 2) help closing gaps in care, ... health and 5) relevant, real-time guidance. Meeting these needs ... costs. A Reason to Stay ...
(Date:3/23/2017)... , Mar 23, 2017 Research and Markets ... & Trends - Industry Forecast to 2025" report to their ... The ... around 6.9% over the next decade to reach approximately $3.5 billion ... and forecasts for all the given segments on global as well ...
(Date:3/23/2017)... LONDON , March 23, 2017 ... comprehensive research report created through extensive primary research ... research, the report aims to present the analysis ... basis of Procedure (Replacement and Repair); Replacement Procedure ... (TAVR)), Repair By Technique (Surgical Devices, Balloon Valvuloplasty, ...
Breaking Medicine Technology:
(Date:3/24/2017)... ... March 24, 2017 , ... As the ... create a communications platform that positions them as the go-to thought leader in ... their online publication as an always-on, always-fresh news, views and advocacy engine, called ...
(Date:3/24/2017)... (PRWEB) , ... March 24, 2017 , ... ... ( http://www.hygieacare.com ) announced their partnership to prep patients for colonoscopy at the ... Endoscopy Centers in 87th Ave., Miami, FL. , The HyGIeaCare® Prep, ...
(Date:3/24/2017)... ... 2017 , ... “Vintage and Harvest A Cultivation of Christian Love” is the ... in North Carolina with his wife, Anna Marie. He and his wife are the ... is also the author of “Shadow and Substance.” , “Love, the agape kind, is ...
(Date:3/23/2017)... Houston, Texas (PRWEB) , ... March 23, 2017 , ... ... their 3rd location in the greater Houston Area. The new location is located at ... St. Luke’s Hospital in Springwoods Village. This newest location will provide patients living in ...
(Date:3/23/2017)... New Holland, PA and Grimsby, Ontario (PRWEB) , ... March 23, 2017 , ... The ... to the modular industry or whose acts have had a significant impact on the careers ... of Sales and Marketing with NRB Inc. was inducted into the MBI’s Hall of Fame. ...
Breaking Medicine News(10 mins):