Navigation Links
Watson Confirms Daytrana(R) Patent Challenge
Date:10/14/2011

PARSIPPANY, N.J., Oct. 14, 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 Methylphenidate Transdermal System, 10 mg/9 hrs, 15 mg/9 hrs, 20 mg/9 hrs, and 30 mg/9 hrs.  Watson's Methylphenidate Transdermal System products are generic versions of Noven Pharmaceuticals, Inc.'s Daytrana(R).  Daytrana(R) is a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Noven filed suit against Watson on October 13, 2011 in the United States District Court of New Jersey seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent Nos. 6,210,705 and 6,348,211.  Noven's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months from the date Noven received notice of Watson's ANDA filing or until 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 versions of Daytrana(R)  and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

For the twelve months ending July 31, 2011, Daytrana(R) had total U.S. sales of over $87 million according to IMS Health data.

About Watson Pharmaceuticals, Inc.Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company.  The Company is engaged in the development, manufacturing, marketing 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 and outcome of the pending patent litigation; the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; 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 31,2010 and Watson's quarterly report on Form 10-Q for the period ended June 30, 2011. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.

Daytrana(R) is a registered trademark of Noven Therapeutics, 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 Provides Update on District Court Order Concerning Generic Version of LOVENOX®
2. Watson Confirms District Court Order Concerning Generic Version of LOVENOX(R)
3. Watson Confirms EMBEDA(R) Patent Challenge
4. Watson Launches Generic FEMCON(R) Fe
5. Watson to Host Conference Call and Webcast to Discuss Third Quarter 2011 Earnings
6. Watson to Present at the Jefferies 2011 Global Healthcare Conference
7. Watson Confirms Amphastar Patent Lawsuit
8. Watson Pharmaceuticals Announces Approval of Amphastars Generic LOVENOX(R)
9. Watson to Present at the 2011 Bank of America Merrill Lynch Global Healthcare Conference
10. Watson to Present at the 2011 Morgan Stanley Global Healthcare Conference
11. Watsons Anda Distribution to Build 234,000 sq ft Pharmaceutical Warehouse and Distribution Facility in Olive Branch, DeSoto County, MS
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/7/2016)... 2016 Global Cervical Dysplasia Market: Scope ... cervical dysplasia market analyzes the current and future ... elaborate executive summary, including a market snapshot that ... The research is a combination of primary ... of our research efforts along with information collected ...
(Date:12/7/2016)... Research and Markets has announced the addition ... Global Forecast to 2021" report to their offering. ... , , The ... growing at a CAGR of 7.3% during the forecast period of 2016 ... cancer and rapidly increasing geriatric population across the globe are the primary ...
(Date:12/7/2016)... Dec. 7, 2016  Palatin Technologies, Inc. ("Palatin") ... on a previously disclosed underwritten public offering of ... acted as sole book-running manager, Roth Capital Partners ... acted as co-manager for the offering. ... in net proceeds, allowing us to continue advancing ...
Breaking Medicine Technology:
(Date:12/8/2016)... (PRWEB) , ... December 08, ... ... Presence Suite 10.2 version gives development continuity to its innovative Unified Instance ... channels management capacity. In addition, this new version optimizes the unattended auto-dialing ...
(Date:12/8/2016)... ... , ... California Senate Bill (SB) 863, signed into law in 2012, may ... 2014, according to CompScope™ Medical Benchmarks for California, 17th Edition , a study ... medical payments per claim in California decreased 4 percent in 2013 and then 3 ...
(Date:12/8/2016)... ... December 08, 2016 , ... Dickinson Insurance ... offices headquartered in Little Rock, has initiated a charity drive to provide support ... Foundation to End Senior Hunger, Arkansas ranks first in senior hunger statewide, third ...
(Date:12/8/2016)... (PRWEB) , ... December 08, 2016 , ... Coppin Insurance ... owners and families in and around the Cape Coral area, is embarking on a ... Food Bank of Southwest Florida. , The Harry Chapin Food Bank of Southwest Florida ...
(Date:12/7/2016)... ... December 07, 2016 , ... DrugDev again ... that it is one of the early adopters completing EU-U.S. Privacy Shield Certification from ... to provide companies on both sides of the Atlantic with a mechanism to comply ...
Breaking Medicine News(10 mins):