Navigation Links
Watson Confirms OxyContin® Patent Challenge
Date:3/25/2011

MORRISTOWN, N.J., March 25, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiaries, Andrx Labs, LLC  and Watson Laboratories, Inc. -- Florida, (collectively "Watson") filed Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) seeking approval to market Oxycodone Hydrochloride Extended-Release tablets in the 10,15, 20, 30, 40, 60 and 80 mg strengths.  Watson's Oxycodone Hydrochloride Extended-Release tablets are a generic version of Purdue Pharma's OxyContin®, which are indicated for the management of moderate to severe pain when continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Purdue Pharma L.P. filed suit against Watson on March 23, 2011 in the United States District Courts for the Southern District of New York,  District of Delaware and Southern District of Florida seeking to prevent Watson from commercializing their products prior to the expiration of U.S. Patents Nos. 6,488,963, 7,674,799, 7,674,800, 7,683,072 and 7,776,314.  Purdue Pharma's lawsuits were filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDAs until August, 2013, or until final resolution of the matters before the courts, whichever occurs sooner, subject to any other exclusivities.  

Based on available information, Watson believes it may be the first applicant to file ANDAs for several strengths of OxyContin® and, should the ANDAs be approved, may be entitled to 180 days of generic market exclusivity.

For the twelve months ending December 31, 2010, OxyContin® had total U.S. sales of approximately $3.1 billion according to IMS Health data.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc. is an integrated 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. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.

OxyContin® is a trademark of Purdue Pharma L.P.

(Logo: http://photos.prnewswire.com/prnh/20100121/LA41294LOGO)

CONTACTS:
Investors:
Patty Eisenhaur
(973) 355-8141

Media:
Charlie Mayr
(973) 355-8483


'/>"/>
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:2/27/2017)... Feb 27, 2017 Period October – December 2016 ... Operating result amounted to SEK -16.4 (-6.4) million Result after ... (-0.22) before and after dilution Cash flow from operating activities ... ... 0.4 (0.4) million Operating result amounted to SEK -39.5 (-29.5) ...
(Date:2/24/2017)... Research and Markets has announced the addition of the ... to 2025" report to their offering. ... The Global Wireless Health Market is ... next decade to reach approximately $330.5 billion by 2025. ... the given segments on global as well as regional levels presented ...
(Date:2/24/2017)... , Feb 24, 2017 Research and Markets ... and Strategies - 2016" report to their offering. ... The latest research Dry eye Drugs Price ... the global Dry eye market. The research answers the following questions: ... Dry eye and their clinical attributes? How are they positioned in the ...
Breaking Medicine Technology:
(Date:2/27/2017)... ... February 27, 2017 , ... This ... laser diffraction analysis as a tool to characterize particle size distributions in the ... obtain improved results and novel scientific findings. It describes methods of optimized and ...
(Date:2/27/2017)... ... February 27, 2017 , ... Silicon Valley Hair ... announce a new informational post on robotic hair transplantation. San Francisco residents may ... transplant and Follicular Unit Transplantation (FUT) can sound similar. Either treatment can be ...
(Date:2/26/2017)... ... February 26, 2017 , ... ... lab became the world’s first to be ISO/IEC 17025:2005 INAB accredited for Der ... , ISO/IEC 17025:2005 is the globally recognised standard that sets out requirements for ...
(Date:2/26/2017)... ... 2017 , ... ODH, Inc.™ announced today it will exhibit and speak ... City Hotel in Arlington, VA. ODH’s director of medical strategy, Candace Saldarini, M.D., will ... Medicaid population health management. , ODH will also have an exhibit booth where attendees ...
(Date:2/24/2017)... (PRWEB) , ... February 24, 2017 , ... ... promotions on tooth replacement options at his office, Antoine Dental Center. Currently, patients ... for $18,499. Some restrictions may apply, but patients can learn more about these ...
Breaking Medicine News(10 mins):