Navigation Links
Watson Confirms Azilect® Patent Challenge
Date:10/5/2010

MORRISTOWN, N.J., Oct. 5 /PRNewswire-FirstCall/ -- 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 rasagiline mesylate 0.5 and 1.0 mg tablets.  Watson's rasagiline mesylate tablets are generic versions of Teva Neuroscience, Inc.'s Azilect® Tablets, which are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease as initial monotherapy and as adjunct therapy to levodopa.

Teva Neuroscience, Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. filed suit against Watson on October 1, 2010 in the United States District Court for the District of New Jersey seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 5,453,446.  Teva'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 November 16, 2013 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 0.5 and 1.0 mg generic versions of Azilect® and, should its ANDA be approved, may be entitled to 180 days of shared generic market exclusivity with other ANDA applicants that filed on the same day as Watson. For the twelve months ending June 30, 2010, Azilect® had total U.S. sales of approximately $108 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 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 31,2009 and Watson's quarterly report on Form 10-Q for the period ended June 30, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.

Azilect® is a registered trademark of Teva Pharmaceutical Industries Ltd.CONTACTS:Investors:Patty Eisenhaur(973) 355-8141Media:Charlie Mayr(973) 355-8483(Logo: http://photos.prnewswire.com/prnh/20100121/LA41294LOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20100121/LA41294LOGO)


'/>"/>

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

Related medicine technology :

1. Watson to Present at the Jefferies 2010 Global SpecPharma & European Healthcare Conference
2. HRA Pharma and Watson Pharmaceuticals Expand Marketing Partnership for Novel Emergency Contraceptive to Canada
3. Watson to Present at the Bank of America/Merrill Lynch Global Healthcare Conference
4. Watsons Generic Yasmin® Receives FDA Approval
5. Watson Names Sigurdur Oli Olafsson Executive Vice President, Global Generics
6. Watson Promotes Robert Stewart to Executive Vice President, Global Operations
7. Watson Confirms Renvela® for Oral Suspension Patent Challenge
8. Watson to Host Conference Call and Webcast to Discuss Second Quarter 2010 Earnings
9. Watson Completes Acquisition of CRINONE® and PROCHIEVE® Product Line and Shares of Columbia Laboratories
10. Watsons Generic Prograf® 5 mg Receives FDA Approval
11. Watson Launches Generic Exelon®
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2016)... 23, 2016 Transparency Market Research ... Pancreatic Insufficiency Market - Global Industry Analysis, Size, Share, ... to the report, the exocrine pancreatic insufficiency market is ... 2015 to 2023 to reach US$2.85 Bn by 2023. ... characterized by the deficiency of the exocrine pancreatic enzymes, ...
(Date:5/23/2016)... May 23, 2016 Experts from ... Precision Medicine and the role of technology in ... The First International Conference of VPS-Penn Medicine opened ... patronage and presence of Sheikh Nahyan bin Mubarak Al Nahyan, ... Precision Medicine, which helps provide personalized medicine and tailor-made healthcare ...
(Date:5/20/2016)... , May 20, 2016 ... 2016 to Medical Devices of its online business ... survey on the current state of the Titrator ... the industry like definitions, classifications, Specifications, applications and ... manufacturing process like Raw Material Suppliers, Equipment Suppliers, ...
Breaking Medicine Technology:
(Date:5/23/2016)... , ... May 23, 2016 , ... ... Texas Veterinary Medical Association (TVMA) reminds pet owners that intervening at the first ... Heatstroke occurs when a pet’s normal body mechanisms cannot keep the body’s temperature ...
(Date:5/23/2016)... ... May 23, 2016 , ... California ... on discriminated minorities’ quality of life and is currently focusing on ways to ... documentaries to be tested through research to find out whether watching them could ...
(Date:5/23/2016)... ... May 23, 2016 , ... During ... Missouri, campus, Standard Process Inc. awarded $6,000 in chiropractic scholarships. The ... Tillman. Each student is in her fifth trimester of classes at Logan. , ...
(Date:5/23/2016)... ... May 23, 2016 , ... Hospice of ... Westchester County for over 24 years, recently hosted its sixth annual Celebration of ... for two remembrance ceremonies, each concluding with the release of Monarch butterflies that ...
(Date:5/23/2016)... (PRWEB) , ... May 23, 2016 , ... ... company’s top management team to meet the needs of its recent and anticipated ... drive continued growth and business development across widening market segments. Max joined the ...
Breaking Medicine News(10 mins):