Navigation Links
Watson Confirms Vyvanse® Patent Challenge
Date:7/7/2011

PARSIPPANY, N.J., July 7, 2011 /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 lisdexamfetamine dimesylate capsules.  Watson's lisdexamfetamine dimesylate capsules are a generic version of Shire LLC's Vyvanse®. Vyvanse® is a prescription medicine for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6 to 17 and adults.

Shire filed suit against Watson on July 7, 2011 in the United States District Court for the Central District of California seeking to prevent Watson from commercializing its product prior to the expiration of certain U.S. Patents. Shire'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 August 23, 2014 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, Vyvanse® capsules had total U.S. sales of approximately $1.1 billion 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.

Vyvanse®  is a registered trademark of Shire LLC.

(Logo: http://photos.prnewswire.com/prnh/20100121/LA41294LOGO)CONTACTS:Investors:Patty Eisenhaur(862) 261-8141Media:Charlie Mayr(862) 261-8030
'/>"/>

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

Related medicine technology :

1. Watson Launches Generic Biaxin(R) XL
2. Watson Announces Positive Results From Its Pivotal Study of Oxybutynin Topical Gel for the Treatment of Overactive Bladder
3. Watson Announces Silodosin NDA Accepted for Filing by FDA for the Treatment of Benign Prostatic Hyperplasia
4. Watson Announces Positive Data for Its New Investigational Products for Benign Prostatic Hyperplasia and Overactive Bladder
5. Watson Announces United States Availability of RAPAFLO(TM) (silodosin), a Novel New Treatment in Benign Prostatic Hyperplasia (BPH)
6. Watson and Barr Settle Lawsuit Over Oxytrol(R)
7. Watson to Host Conference Call and Webcast to Discuss Fourth Quarter 2009 Earnings and 2010 Outlook
8. Watson Completes Acquisition of Eden Biodesign
9. Watson to Present at Credit Suisse Healthcare Conference
10. Watson Announces New Program to Help Promote Good Bone Health in Advanced Prostate Cancer Patients on Long-Term Androgen Deprivation Therapy
11. Watson Files FDA Application for Generic Rozerem(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... 2017 Research and Markets has announced the ... Strategies - 2016" report to their offering. ... The latest research Autism Spectrum ... data and benchmarks in the global Autism Spectrum Disorder market. ... What are the key drugs marketed for Autism Spectrum Disorder and ...
(Date:2/23/2017)... , Feb. 23, 2017 ITL Limited, ( ASX: ... excellent results for the half year ended 31 December 2016 compared ... Growth Update" presentation can be viewed here . ... (Dec 2015: $1.04m; up 104%) Earnings per share ... Revenue of $17.5m (Dec 2015: $15.7m; up 11%) ...
(Date:2/23/2017)... Feb 23, 2017 Research and Markets has ... and Strategies - 2016" report to their offering. ... The latest research Oesophageal ... data and benchmarks in the global Oesophageal Cancer market. ... What are the key drugs marketed for Oesophageal Cancer and their ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... February 24, 2017 , ... Castle Farms, the ... Military Wedding Giveaway, with the winning couple announced on Feb. 14, 2017, on ... donated from local vendors: A Matter of Taste, Ryan Rousseau Enterprises, A Touch ...
(Date:2/23/2017)... ... ... The 89th Academy Awards will be celebrated this weekend, which means it’s ... Award. We invite you to enjoy our 11th annual tongue-in-cheek “salute” to the shoddiest ... for American Progress (CAP), for its report, Lessons From State Performance on NAEP: Why ...
(Date:2/23/2017)... Chapel Hill, NC (PRWEB) , ... February 23, 2017 , ... ... the Platinum Sponsor for ACPA’s 74th Annual Meeting. KLS is a longtime supporter ... in 2017 as an exhibitor and Platinum Sponsor," said Dr. Bob Havlik, 2017 ACPA ...
(Date:2/23/2017)... ... February 23, 2017 , ... Rosica Communications, ... relations, content marketing, social media management, corporate communications, SEO and cause marketing, is ... and in nearby New Hampshire, Massachusetts and Canada, Rosica will focus on expanding ...
(Date:2/23/2017)... ... ... Dr. David Mahon leads Siena Dental, a comprehensive dental practice located at 10075 ... Patient Rated Henderson Dentist by Find Local Doctors earlier this year. ... who have earned high ratings and superior patient reviews from multiple credible sources. , ...
Breaking Medicine News(10 mins):