Navigation Links
Watson Confirms EMBEDA(R) Patent Challenge
Date:10/7/2011

PARSIPPANY, N.J., Oct. 7, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Morphine Sulfate and Naltrexone Hydrochloride Extended-release Capsules 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 mg, 80 mg/3.2 mg, and 100 mg/4 mg.  Watson's Morphine Sulfate and Naltrexone Hydrochloride Capsules are generic versions of EMBEDA® Extended Release Capsules sold by King Pharmaceuticals, Inc., a wholly-owned subsidiary of Pfizer Inc. EMBEDA® is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Pfizer, King and Alpharma Pharmaceuticals LLC filed suit against Watson on October 6, 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 Nos. 7,682,633; 7,682,634; and 7,815,934.  The lawsuit 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 from the date the plaintiffs received notice of Watson's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Based on available information, Watson believes it may be a "first applicant" to file an ANDA for the generic version of EMBEDA® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

For the twelve months ending August 31, 2011, EMBEDA® had total U.S. sales of approximately $42 million according to IMS Health data.

About Watson Pharmaceuticals, Inc.Watson Pharmaceuticals, Inc. is a leading integrated global pharmaceutical company. The Company is engaged in the development 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 or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the difficulty of predicting the timing and outcome of the pending patent litigation; 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 quarterly report on form 10-Q for the quarter ended June 30, 2011 and Watson's annual report on Form 10-K for the year ended December 31, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.

EMBEDA® is a registered trademark of Alpharma Pharmaceuticals LLC.

(Logo: http://photos.prnewswire.com/prnh/20100121/LA41294LOGO) CONTACTS:Investors:Patty Eisenhaur(862) 261-8141Media:Charlie Mayr(862) 261-8030
'/>"/>

SOURCE Watson Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Watson Launches Generic FEMCON(R) Fe
2. Watson to Host Conference Call and Webcast to Discuss Third Quarter 2011 Earnings
3. Watson to Present at the Jefferies 2011 Global Healthcare Conference
4. Watson Confirms Amphastar Patent Lawsuit
5. Watson Pharmaceuticals Announces Approval of Amphastars Generic LOVENOX(R)
6. Watson to Present at the 2011 Bank of America Merrill Lynch Global Healthcare Conference
7. Watson to Present at the 2011 Morgan Stanley Global Healthcare Conference
8. Watsons Anda Distribution to Build 234,000 sq ft Pharmaceutical Warehouse and Distribution Facility in Olive Branch, DeSoto County, MS
9. Watson Enters into Agreement to Acquire Products Related to Perrigos Acquisition of Paddock Laboratories
10. Watson Second Quarter 2011 Net Revenue Exceeds $1 Billion; Non-GAAP EPS of $1.01
11. Watson Confirms JALYN™ Patent Challenge
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/20/2017)... -- Provides understanding and access to the anemia ... worlds leading healthcare companies. Download the full ... Anemia Partnering Terms and Agreements since 2010 report ... agreements entered into by the world,s leading healthcare ... - Top deals by value - ...
(Date:2/20/2017)... Feb. 20, 2017 This report analyzes the worldwide ... market is analyzed by the following Segments: Biologic Meshes, and ... US, Canada , Japan ... , and Rest of World. Read the ... forecasts are provided for the period 2015 through 2022. Also, ...
(Date:2/20/2017)... , Feb. 20, 2017  Henry Schein, ... health care products and services to office-based ... announced that it has entered into an ... (SAS), a leading U.S. distributor of anesthesia ... anesthesiologists, and periodontists. SAS offers controlled and ...
Breaking Medicine Technology:
(Date:2/19/2017)... (PRWEB) , ... February 19, 2017 , ... Braun Industries ... JEMS Conference & Exposition, the event will take place February 23-25, 2017 at the ... will be in Booth #909 with three new ambulances on display. ...
(Date:2/18/2017)... ... February 17, 2017 , ... ... , Sponsored by Axendia, **FDAnews Free Webinar**, March 1, 2017 — 1:30 ... to reduce their regulatory burden? Pay dividends in enhanced and predictable product ...
(Date:2/18/2017)... ... ... Park Cities Pet Sitter President, Joette White, has been featured on Episode ... The episode, which was posted this week, features a 30-minute interview of White by ... Pet Sitter’s being awarded the 2017 National Association of Professional Pet Sitter’s Business of ...
(Date:2/17/2017)... ... 2017 , ... While EHR data has revolutionized the nursing ... workstation designed to reduce nursing fatigue while enhancing productivity. Based on field experience ... lightweight, highly mobile, multi-functional alternative to the limitations of handheld computing. , Nurses ...
(Date:2/17/2017)... ... February 17, 2017 , ... ... , **An FDAnews Webinar**, Feb. 22, 2017 — 1:30 p.m. – 2:30 ... questions manufacturers should be asking before selecting an FDA approval pathway? , ...
Breaking Medicine News(10 mins):