Navigation Links
Watson Confirms Azilect® Patent Challenge

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

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:



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:
(Date:11/26/2015)... , November 26, 2015 3D bioprinting ... 2022, according to a new report by Grand View Research ... Disease (CKD) which demands kidney transplantation is expected to boost ... effective substitute for organ transplantation. --> 3D bioprinting ... 2022, according to a new report by Grand View Research ...
(Date:11/26/2015)... 2015 --> ... potential att använda SyMRI för att hitta ... patienter med multipel skleros (MS) eller hjärntumörmetastaser ... AB för att kunna använda SyMRI Research ... SyMRI kan man generera flera konstrastbilder från ...
(Date:11/26/2015)... DUBLIN , Nov. 26, 2015 ... the addition of the "2016 Future Horizons ... Monitoring (TDM) Market: Supplier Shares, Country Segment Forecasts, ... offering. --> ... comprehensive analysis of the Italian therapeutic drug monitoring ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... , ... According to an article published November 6th by The ... of British Columbia suggested that laws requiring bicyclists to wear helmets may not actually ... the reason for the controversial conclusion is that, while helmets have certainly prevented a ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... toilets were," said an inventor from Hillside, N.J. "Many people catch diseases simply ... so that individuals will always be protected from germs." , He developed the ...
(Date:11/27/2015)... , ... November 27, 2015 , ... ... of progress through sharing, the 2016 Building Better Radiology Marketing Programs ... will begin on Sunday, March 6, 2016, at Caesars Palace in Las Vegas ...
(Date:11/27/2015)... ... November 27, 2015 , ... CBD College is proud to ... Programs (CAAHEP) awarded accreditation to its Diagnostic Medical Sonography program. CBD College is honored ... one of twelve colleges and universities in the state of California make the cut. ...
(Date:11/26/2015)... ... November 26, 2015 , ... Patients at Serenity ... have come together on Thanksgiving Day to share the things that they are ... the Serenity Point YouTube channel, patients displayed what they wrote on index cards, ...
Breaking Medicine News(10 mins):