Navigation Links
Watson Files FDA Application for Generic Rozerem(R)
Date:12/4/2009

MORRISTOWN, N.J., Dec. 4 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc.-Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 8mg ramelteon tablets prior to the expiration of a patent owned by Takeda Pharmaceutical Company Limited. Watson's 8mg ramelteon tablet product is a generic version of Takeda's Rozerem®, which is indicated for the treatment of insomnia characterized by difficulty with sleep onset.

Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America, Inc. filed suit against Watson on December 2, 2009 in the U.S. District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 6,034,239. Takeda's suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA 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 a "first applicant" to file an ANDA for a generic version of Rozerem® and, should its ANDA be approved, may be entitled to 180 days of shared generic market exclusivity.

For the twelve months ending September 30, 2009, Rozerem® had total U.S. sales of approximately $91 million according to IMS Health data.

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 over 20 countries including 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 quarterly report on Form 10-Q for the period ended September 30, 2009. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.

Rozerem® is a registered trademark of Takeda Pharmaceutical Company Limited.

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

SOURCE Watson Pharmaceuticals, Inc.


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

Related medicine technology :

1. Watson to Present at Credit Suisse Healthcare Conference
2. Watson and Barr Settle Lawsuit Over Oxytrol(R)
3. Watson Announces United States Availability of RAPAFLO(TM) (silodosin), a Novel New Treatment in Benign Prostatic Hyperplasia (BPH)
4. Watson Announces Positive Data for Its New Investigational Products for Benign Prostatic Hyperplasia and Overactive Bladder
5. Watson Announces Silodosin NDA Accepted for Filing by FDA for the Treatment of Benign Prostatic Hyperplasia
6. Watson Announces Positive Results From Its Pivotal Study of Oxybutynin Topical Gel for the Treatment of Overactive Bladder
7. Watson Launches Generic Biaxin(R) XL
8. Cardium Files FDA 510(k) Application for U.S. Marketing Clearance of ExcellagenXL(TM) Topical Gel and ExcellagenFX(TM) Flowable Collagen Protein-Based Matrix for Diabetic, Pressure and Venous Ulcers and Other Dermal Wounds
9. Cephalon Files Patent Infringement Lawsuit Against Teva Pharmaceuticals
10. Endologix Files Motion to Discontinue Court Proceedings Related to Alleged Patent Infringement
11. Vermillion Files Plan of Reorganization
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/9/2016)... , Dec. 9, 2016 aTyr Pharma, Inc. (Nasdaq: ... development of Physiocrine-based therapeutics to address severe, rare diseases, today announced ... upcoming BMO Prescriptions for Success Healthcare Conference at the InterContinental Barclay ... December 14, 2016, at 4:20 p.m. ET. About ... ...
(Date:12/9/2016)... , Dec. 9, 2016 Department of Health ... regulations for medical marijuana dispensaries under Act 16 are ... , and are now available online . ... in the plan for operation; process for dispensing medical ... well as where the dispensary facilities can be located," ...
(Date:12/8/2016)... VIEW, Calif. , Dec. 8, 2016 IRIDEX ... intends to offer newly issued shares of common stock, $0.01 ... pursuant to an underwritten public offering.  The final terms of ... the time of pricing, and there can be no assurance ... IRIDEX expects to use the net proceeds it ...
Breaking Medicine Technology:
(Date:12/8/2016)... ... December 08, 2016 , ... The West Virginia Medical Institute ... The name change aligns the entire company with its existing Quality Insights ... , “We are very proud of the achievements associated with the West Virginia ...
(Date:12/8/2016)... (PRWEB) , ... December 08, 2016 , ... ... Donuts Franchising Company LLC, announced the first national #QuackGivesBack campaign which supported ... , “This was our first franchise-wide Quack Gives Back initiative, and ...
(Date:12/8/2016)... ... 08, 2016 , ... Mirixa Corporation , a leading ... pharmacist-delivered patient care services, has announced the promotions of Karen Litsinger to senior ... of sales. , Litsinger joined Mirixa in 2008 after serving as a ...
(Date:12/8/2016)... (PRWEB) , ... December 08, 2016 , ... David ... with global law firm Greenberg Traurig, LLP, will speak at DeviceTalks West, Dec. 12, ... of the DeviceTalks series, and attorneys from the firm’s global Life Sciences & Medical ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... development continuity to its innovative Unified Instance Manager architecture, meeting the needs ... this new version optimizes the unattended auto-dialing system without agents, Presence Robodialer, ...
Breaking Medicine News(10 mins):