Navigation Links
Watson Confirms Welchol® Oral Suspension Patent Challenge
Date:1/25/2011

MORRISTOWN, N.J., Jan. 25, 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 Colesevelam HCI powder for oral suspension, 1.875 gm/packet and 3.75 gm/packet.  Watson's Colesevelam HCI powder for oral suspension is a generic version of Daiichi Sankyo, Inc.'s Welchol ® oral suspension, which is indicated to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia as monotherapy or in combination with an hydroxymethyl-glutarylcoenzyme A (HMG CoA) reductase inhibitor (statin); to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia as monotherapy or in combination with a statin after failing an adequate trial of diet therapy; and to improve glycemic control in adults with type 2 diabetes mellitus.

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

Daiichi Sankyo and Genzyme Corporation filed suit against Watson on January 21, 2011 in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 5,693,675.  Daiichi Sankyo'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 June 19, 2013, or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.  

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 31,2009 and Watson's quarterly report on Form 10-Q for the period ended September 30, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.

Welchol® is a trademark of Daiichi Sankyo, Inc.CONTACTS:Investors:Patty Eisenhaur(973) 355-8141Media: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:10/12/2017)... --  Divoti USA will engrave and process all ... the latest FDA requirements, which stipulates new criteria regarding medical device ... of Medical ID jewelry such as Medical ID Bracelets, can rest ... terms of the new FDA requirements . ... Divoti offers this dark mark fiber laser engraving ...
(Date:10/11/2017)... , Oct. 11, 2017  BioPharmX Corporation (NYSE ... team that developed an innovative way to use nonlinear ... the delivery of new drugs. ... Clinical Dermatology Conference will show how researchers from BioPharmX ... Harvard Medical School used a suite of imaging techniques ...
(Date:10/11/2017)...  True Health, a leader in integrated diagnostics ... National Breast Cancer Awareness month to educate doctors ... Research recently published in ... than 10 million American women are at significant ... BRCA2 and have not had testing. These mutations can ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional women, ... towards gender equality at their inaugural Summit in New York City in June. The ... social audience of over 3 million. To watch the Mobilize Women video, click ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Software Development, has been awarded a contract by the Center for Medicare and ... aims to accelerate the enterprise use of Agile methodologies in a consistent and ...
(Date:10/12/2017)... San Francisco, CA (PRWEB) , ... October 12, ... ... and Dr. Cheng, are now treating sleep apnea using cutting-edge Oventus ... sleep apnea, a serious sleep disorder characterized by frequent cessation in breathing. Oral ...
(Date:10/12/2017)... Bethesda, MD (PRWEB) , ... October 12, 2017 , ... ... Award of Excellence to Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s ... 4 – 8. , In honor of Morris F. Collen, a pioneer in the ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader in ... 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced ... 2017. , The annual award competition recognizes editorial and design excellence across a range ...
Breaking Medicine News(10 mins):