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:6/26/2016)... Jazz Pharmaceuticals plc (Nasdaq: JAZZ ... Antitrust Improvements Act of 1976, as amended ("HSR"), with ... ("Celator"; Nasdaq: CPXX ) expired effective June ... As previously announced on May 31, 2016, Jazz ... under which Jazz Pharmaceuticals has commenced a tender offer ...
(Date:6/24/2016)... 2016  Consumers have taken a more active ... more emphasis on patient outcomes. ... the pharmaceutical industry have evolved beyond just providing ... are focusing on becoming more patient-oriented across their ... services that improve health. ...
(Date:6/24/2016)... CAMBRIDGE, Mass. , June 24, 2016 /PRNewswire/ ... the Spaulding Rehabilitation Network,s Dean Center for ... of Physical Medicine and Rehabilitation, MIT Hacking Medicine, ... Center for Innovation, today announced the five finalists ... Hackathon for Lyme disease.  More than 100 scientists, ...
Breaking Medicine Technology:
(Date:6/27/2016)... , ... June 27, 2016 , ... ... edge technology to revolutionize the emergency ambulance transport experience for the millions of ... of how Uber has disrupted the taxi industry through the use of technology. ...
(Date:6/26/2016)... Carolina (PRWEB) , ... June 26, 2016 , ... ... of a new product that was developed to enhance the health of felines. The ... centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/25/2016)... FL (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial ... Plant City Observer , brings up a new, often overlooked aspect of head lice: the ... closing for fumigation is not a common occurrence, but a necessary one in the event ...
(Date:6/25/2016)... ... 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the Maryland ... iHire in recognition of their exemplary accomplishments in worksite health promotion. , The Wellness ... & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one of ...
(Date:6/24/2016)... ... ... a crisis. Her son James, eight, was out of control. Prone to extreme mood shifts ... upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife ... and say he was going to kill them. If we were driving on the ...
Breaking Medicine News(10 mins):