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:12/9/2016)... Japan , Dec. 9, 2016 Mitsubishi ... ; President & Representative Director, CEO: Dr. Masayuki ... amyotrophic lateral sclerosis (ALS) given edaravone intravenously in 10-14 ... loss as measured by the ALS Functional Rating Scale-Revised ... International Symposium on ALS/MND in Dublin, ...
(Date:12/9/2016)... DUBLIN , Dec 9, 2016 Research ... Vaccines Market 2016-2020" report to their offering. ... The global travel vaccines market ... The report covers the present scenario and the growth ... the market size, the report considers the revenue generated from the ...
(Date:12/9/2016)... Dec. 9, 2016  Forge Therapeutics, Inc. today ... Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) to advance ... the treatment of bacterial infections including those caused ... as an attractive antibacterial target for more than ... suitable chemical starting points has hampered its progress. ...
Breaking Medicine Technology:
(Date:12/9/2016)... ... 2016 , ... Groth Family Insurance, a Washington-based firm offering ... a charity drive to support the family of Cindy Hendrickson, a local mother ... On October 29th of this year, Cindy Hendrickson swerved to avoid an oncoming ...
(Date:12/9/2016)... Ohio (PRWEB) , ... December 09, 2016 , ... ... of miniature, folded, pharmaceutical inserts and outserts. As a means of expanding ... This addition will enable Flottman to individually code professional inserts (PIs) and patient ...
(Date:12/9/2016)... Yorktown Heights, NY (PRWEB) , ... December 09, 2016 , ... ... on Alcoholism and Drug Dependence, Inc. (NCADD) is recommending the film Whispering ... 29 states and the District of Columbia as an education tool in the war ...
(Date:12/9/2016)... (PRWEB) , ... December 09, 2016 , ... An inventor ... amputees to safely ride all types of amusement park rides. , The patent-pending SAFETY ... unit is easy to use and could be set up in a matter of ...
(Date:12/9/2016)... ... December 09, 2016 , ... ... Pierre Hotel in New York, NY, on December 3rd, to benefit Holy Name ... attended the annual event, which raised over $1 million - the largest event ...
Breaking Medicine News(10 mins):