Navigation Links
Watson Files FDA Applications for Generic Mucinex(R)
Date:4/22/2009

- Paragraph IV Litigation Underway -

CORONA, Calif., April 22 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today confirmed that it has filed two Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration seeking approval to market its guaifenesin extended-release 600mg and 1200mg tablets and its dextromethorphan HBr/guaifenesin extended-release 30mg/600mg and 60mg/1200mg tablets prior to the expiration of patents owned by Reckitt Benckiser Inc. Watson's guaifenesin and dextromethorphan HBr/guaifenesin extended-release tablet products are the generic versions of Reckitt Benckiser Inc.'s Mucinex(R) and Mucinex(R) DM products which are indicated to help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Reckitt Benckiser filed suit against Watson on April 20, 2009 in the U.S. District Court for the Southern District of New York seeking to prevent Watson from commercializing its products prior to expiration of U.S. patent numbers 6,372,252 and 6,955,821. Reckitt Benckiser's suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of final FDA approval of Watson's ANDAs for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Based on available information, Watson believes it may be the first applicant to file an ANDA for a generic version of Mucinex DM(R) and, should its product be approved, may be entitled to 180 days of generic market exclusivity.

For the twelve-months ended December 31, 2008, Mucinex(R) and Mucinex(R) DM products had total U.S. sales of approximately $106 million and $85 million respectively, according to IMS Health data.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc. is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialized portfolio of brand pharmaceuticals focused on Urology, Women's Health and Nephrology/Medical.

For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.

Watson's Forward-Looking Statement

Any statements contained in this press release that refer to future events 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. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. 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 difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the difficulty of predicting the timing or outcome of litigation related to patent infringement; the impact of competitive products and pricing; market acceptance of and continued demand for Watson's products; and 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, 2008.

Mucinex(R) and Mucinex(R) DM are the registered trademarks of Reckitt Benckiser Inc.

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


'/>"/>
SOURCE Watson Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility
2. Watson Wyatt Identifies Major Benefit Trends During Open Enrollment Season
3. Texas Affiliates of Susan G. Komen for the Cure, Sen. Kirk Watson, Rep. Patrick Rose, Singer Kelly Willis, Breast Cancer Survivors and Activists Rally for Passage of Proposition 15
4. Watson Files FDA Application for Generic YAZ(R)
5. Watson Names Mark Durand Chief Financial Officer
6. Watson and Novartis Settle Lawsuit Over Exelon(R) Patent Litigation
7. Barr Subsidiary Sues Watson and Sandoz for SEASONALE(R) Patent Infringement
8. Watson Confirms Patent Litigation With Barr Related to Seasonale(R)
9. Watson Receives FDA Approval for Generic DuoNeb(R)
10. Watson to Distribute Alendronate Tablets
11. Medical Cost Increases to Accelerate Worldwide Over Next Five Years, Watson Wyatt Poll Finds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/27/2017)... (PRWEB) , ... March 27, 2017 , ... ... business simulation -centric training, today announced the launch of a new research study, ... having the skills needed to execute that strategy, and the actual success of ...
(Date:3/27/2017)... ... ... Janet Schloz is still in shock after receiving a $2,500 Academic Award from California ... she said. , She thinks the coming week is going to be a very joyful ... to help my students.” , The award will allow the 4th grade teacher at Tumwater ...
(Date:3/27/2017)... ... March 27, 2017 , ... Mt. Angel Vitamins, ... a months-long rebranding effort. This includes the introduction of new packaging and messaging, ... market research, we learned that a simple, proactive approach to wellness is important ...
(Date:3/27/2017)... ... March 27, 2017 , ... The homeowner improvement and repair market ... utilizing DIY and unlicensed contractors for renovations is also on the rise. Per a ... 2015, and of those, 42% failed to use a licensed contractor.(2) The risks associated ...
(Date:3/25/2017)... , ... March 25, 2017 , ... Norland at Swissray is pleased to ... for large subjects. The ELITE DXA has an active scan window, which is more ... long to fit in the scan area could not undergo an accurate total body bone ...
Breaking Medicine News(10 mins):
(Date:3/27/2017)... and BOSTON , March 27, ... global pharmaceutical company and Paratek Pharmaceuticals, Inc. (Nasdaq: ... and commercialization of innovative therapies based upon tetracycline ... of sarecycline for the treatment of moderate to ... endpoints. Sarecycline is a once-daily, oral, narrow spectrum ...
(Date:3/27/2017)... 27, 2017  PhaseRx, Inc. (NASDAQ: PZRX), a ... liver diseases in children, today reported financial results ... December 31, 2016 and provided an update on ... to make progress during the fourth quarter of ... our non-human primate safety study, and with our lead ...
(Date:3/24/2017)... Research and Markets has announced the addition of the ... offering. ... The Cell Therapy Manufacturing Market, 2017-2027 report provides an extensive ... and focuses both on contract manufacturers and cell therapy developers ... as viable alternatives to conventional treatment options. ...
Breaking Medicine Technology: