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:4/20/2017)... Sweden , April 20, 2017 ... NEVPF) ("NeuroVive") today announced positive preclinical results ... preclinical compound for non-alcoholic steatohepatitis (NASH), in ... NV556 has previously shown ... NASH model. Today, NeuroVive,s scientists present novel ...
(Date:4/19/2017)...  IRIDEX Corporation (Nasdaq: IRIX ) today ... first quarter 2017 after the close of trading on ... host a corresponding conference call beginning at 2:30 p.m. ... in listening to the conference call may do so ... 326-3030 for international callers, using conference ID: 92158987.  A ...
(Date:4/19/2017)... 2017  Sorrento Therapeutics, Inc. (NASDAQ: ... developing new treatments for cancer and other unmet ... previously announced underwritten public offering of 23,625,084 shares ... price of $2.00 per share, before deducting underwriting ... by Sorrento.  The net proceeds to Sorrento from ...
Breaking Medicine Technology:
(Date:4/24/2017)... New York, NY (PRWEB) , ... April 24, ... ... students in 72 countries clearly shows that over the last decade, student well-being ... have ticked all the boxes of formal education, join the Islamic State to ...
(Date:4/24/2017)... ... April 24, 2017 , ... Miami Periodontist ... the 2017 Oral Reconstruction Foundation’s 2017 Symposium on Tissue Regeneration and Implant Dentistry ... present its annual Global Symposium at the Fontainebleau Hotel located in Miami Beach, ...
(Date:4/24/2017)... ... , ... A 2-in-1 bottleless water appliance provides both purified ... Texas, here are the ways in which this technology can benefit dental offices: ... fresh, oxygenated water, with both cold and hot options. , Convenience for Dentists ...
(Date:4/22/2017)... Philadelphia, PA (PRWEB) , ... ... ... Small Business Administration of Eastern Pennsylvania has named PROSHRED® Security of ... Pennsylvania-native Ginny Heron-Doerr, PROSHRED® Philadelphia specializes in providing information destruction ...
(Date:4/21/2017)... (PRWEB) , ... April 21, 2017 , ... An April ... of a pair of ancient teeth, which reveal a great deal about prehistoric ice-age ... a sharp stone may have been used to remove decayed dental matter, and that ...
Breaking Medicine News(10 mins):