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:8/11/2017)... CAESAREA, Israel , Aug. 11, 2017 ... company with mobile health and big data solutions, today ... results on Monday, August 14 and host a conference ... second quarter 2017 operating and financial results and its ... call will be hosted by Erez Raphael , ...
(Date:8/7/2017)... Insightin Health, provider of data-driven decision-making ... announced the selection of Michael Wood ... as of February 2017. In this role, Wood will ... our clients. Wood brings with him more than ... analytics within the healthcare industry. Wood formerly served ...
(Date:8/7/2017)... Aug. 7, 2017  Endo International plc (NASDAQ: ... to resolve virtually all known U.S. mesh product liability ... resolve the known remaining U.S. claims at reasonable values. ... in the fourth quarter of 2017 and continuing through ... second quarter 2017 results, the Company intends to increase ...
Breaking Medicine Technology:
(Date:8/19/2017)... ... August 19, 2017 , ... Physician Partners of America Pain ... an interventional pain management physician. He brings a wealth of pain management experience ... and significant experience in spinal cord stimulation for chronic pain. , Dr. Ahmed ...
(Date:8/18/2017)... ... August 18, 2017 , ... ... LLC (“Quick”), a highly specialized asset-light logistics provider of complex transport solutions ... definitive agreement to purchase Unitrans International Corporation, a division of Roadrunner Transportation ...
(Date:8/18/2017)... ... ... The Dawn Johnson Insurance Group, a Missouri-based insurance and financial planning firm ... for efforts to educate the local population on cancer realities while attracting donations to ... , Each day in America, roughly 4,600 new cases of cancer are diagnosed and ...
(Date:8/18/2017)... Saint John, IN (PRWEB) , ... August 18, 2017 , ... ... services to communities in northwest Indiana, is campaigning in support of Campagna Academy in ... Formerly referred to as the “Hoosier Boys’ Town of Indiana,” Campagna Academy is a ...
(Date:8/18/2017)... ... 18, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh in Abilene, ... on false teachings pertaining to the mother of the Savior whom the world calls “Mother ... different picture of the role of this historical woman. , “The world bows, kisses ...
Breaking Medicine News(10 mins):