Navigation Links
Watson Confirms Filing of Generic Opana(R) ER Application
Date:3/8/2010

MORRISTOWN, N.J., March 8 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has been sued by Endo Pharmaceuticals Inc. and Penwest Pharmaceuticals Co. in connection with the filing of Watson's Abbreviated New Drug Application (ANDA) for Oxymorphone Hydrochloride Extended-Release Tablets, 40mg.  Watson's Oxymorphone Hydrochloride Extended-Release Tablets product is a generic version of Endo's Opana® ER which is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.  Opana® ER had approximately $245 million in brand sales for the twelve months ending December 31, 2009, according to IMS Health.

On January 19, 2010, pursuant to the Hatch-Waxman Act, Watson notified Endo and Penwest that its ANDA contained a paragraph IV certification asserting that U.S. Patent Nos. 5,662,933, 5,958,456, and 7,276,250, which are listed in the Orange Book for Opana® ER, are invalid, unenforceable and/or not infringed.  

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 Watson's estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release.  For instance, any statements in this press release concerning prospects related to Watson's product introductions and anticipated financial performance are forward-looking statements.  It is important to note that Watson's goals and expectations are not predictions of actual performance.  Watson's performance, at times, will differ from its goals and expectations.  Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business.  These factors include, among others, the inherent uncertainty associated with financial projections; the impact of competitive products and pricing; the difficulty of predicting the timing or outcome of litigation; the timing and success of product launches; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; market acceptance of and continued demand for Watson's products; 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's and its third party manufacturers' facilities, products and/or businesses; 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 period ended December 31, 2009. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.  

Opana® ER is a registered trademark of Endo Pharmaceuticals Inc.

(Logo:  http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO)

SOURCE Watson Pharmaceuticals, Inc.

Back to top

RELATED LINKS
http://www.watson.com

'/>"/>

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

Related medicine technology :

1. Watson Signs Agreement to Divest Equity Interest in ScinoPharm
2. Watson to Present at CLSA/Asia USA Investors Forum
3. Watson to Host Conference Call and Webcast to Discuss Fourth Quarter 2009 Earnings and 2010 Outlook
4. Watson Completes Acquisition of Eden Biodesign
5. Watson Announces New Program to Help Promote Good Bone Health in Advanced Prostate Cancer Patients on Long-Term Androgen Deprivation Therapy
6. Watson Files FDA Application for Generic Rozerem(R)
7. Watson to Present at Credit Suisse Healthcare Conference
8. Watson and Barr Settle Lawsuit Over Oxytrol(R)
9. Watson Announces United States Availability of RAPAFLO(TM) (silodosin), a Novel New Treatment in Benign Prostatic Hyperplasia (BPH)
10. Watson Announces Positive Data for Its New Investigational Products for Benign Prostatic Hyperplasia and Overactive Bladder
11. Watson Announces Silodosin NDA Accepted for Filing by FDA for the Treatment of Benign Prostatic Hyperplasia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/15/2017)... Inc. announced today that its fully owned USA ... York City Office in Yonkers, New York ... (TWO 2 ) homecare therapy. This new East Coast location has ... under the company,s DMEPOS accreditation for Home/Durable Medical Equipment Services. ... Advanced Oxygen Therapy Inc. New ...
(Date:8/8/2017)... --   Second-quarter 2017 revenues ... per share from continuing operations ... percent to $110 million ... $161 million Second-quarter 2017 ... increased 8 percent to $0.93 ...
(Date:8/7/2017)... DUBLIN , Aug. 7, 2017  Endo International ... has reached agreements to resolve virtually all known U.S. ... in discussions to resolve the known remaining U.S. claims ... installment payments beginning in the fourth quarter of 2017 ... part of its second quarter 2017 results, the Company ...
Breaking Medicine Technology:
(Date:8/19/2017)... ... August 19, 2017 , ... Yesterday, the President of the United States ... two sides. There are not two sides to hatred, bigotry, discrimination, and a white ... and the NPEIV stands against all forms of such hatred and discrimination in this ...
(Date:8/18/2017)... ... August 19, 2017 , ... Mr. ... presided over the Amazing Thailand Health and Wellness Tourism Showcase 2017 yesterday, which ... Pakprot, Deputy Governor for Tourism Products and Business at TAT said, “Thailand has ...
(Date:8/18/2017)... York, NY (PRWEB) , ... August 18, 2017 ... ... edition of “Vision & Hearing” campaign, advocating for active, healthy lifestyles and highlighting ... resources available for individuals with hearing impairments and shares the latest innovations in ...
(Date:8/18/2017)... , ... August 18, 2017 , ... The Dawn Johnson ... inaugurating a new charity drive to generate community support for efforts to educate the ... cures and treatments for all types of cancer. , Each day in America, ...
(Date:8/18/2017)... ... 2017 , ... MLM Insurance Group, a Miami area provider ... is working to support the Take Stock In Children Foundation during a regional ... The Take Stock In Children Foundation (TSC) offers guidance and assistance to low ...
Breaking Medicine News(10 mins):