Navigation Links
Watson Confirms Exalgo™ Patent Challenge
Date:12/14/2010

MORRISTOWN, N.J., Dec. 14, 2010 /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 Hydromorphone Hydrochloride Extended-release Tablets, 8 mg, 12 mg, and 16 mg.  Watson's Hydromorphone Hydrochloride Extended-release Tablets are a generic version of Mallinckrodt Inc.'s Exalgo™ tablets, which are indicated for once daily administration for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

Mallinckrodt filed suit against Watson on December 10, 2010 in the United States District Court for the District of New Jersey seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 5,914,131.  Mallinckrodt's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA until April 29, 2013, 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 8 mg, 12 mg, and 16 mg generic versions of Exalgo™ and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

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 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 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 annual report on Form 10-K for the year ended December 31,2009 and Watson's quarterly report on Form 10-Q for the period ended September 30, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.

Exalgo™ is a trademark of Mallinckrodt Inc.CONTACTS:  Investors:Patty Eisenhaur(973) 355-8141Media:Charlie Mayr(973) 355-8483(Logo: http://photos.prnewswire.com/prnh/20100121/LA41294LOGO)


'/>"/>

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

Related medicine technology :

1. Watson Launches Generic Biaxin(R) XL
2. Watson Announces Positive Results From Its Pivotal Study of Oxybutynin Topical Gel for the Treatment of Overactive Bladder
3. Watson Announces Silodosin NDA Accepted for Filing by FDA for the Treatment of Benign Prostatic Hyperplasia
4. Watson Announces Positive Data for Its New Investigational Products for Benign Prostatic Hyperplasia and Overactive Bladder
5. Watson Announces United States Availability of RAPAFLO(TM) (silodosin), a Novel New Treatment in Benign Prostatic Hyperplasia (BPH)
6. Watson and Barr Settle Lawsuit Over Oxytrol(R)
7. Watson to Host Conference Call and Webcast to Discuss Fourth Quarter 2009 Earnings and 2010 Outlook
8. Watson Completes Acquisition of Eden Biodesign
9. Watson to Present at Credit Suisse Healthcare Conference
10. Watson Announces New Program to Help Promote Good Bone Health in Advanced Prostate Cancer Patients on Long-Term Androgen Deprivation Therapy
11. Watson Files FDA Application for Generic Rozerem(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... , May 25,2016 ... the near-infrared Cellvizio platform for urological and surgical ... OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary confocal ... regulatory milestone in the US with the 12 ... and Drug Administration (FDA). This new FDA clearance ...
(Date:5/25/2016)... India , May 25, 2016 ... Animation Market by Type (3D, 2D, 4D), by Therapeutic ... Education), by End User (Medical Device Manufacturers, Hospitals/ Clinics) ... studies the global Medical Animation Market for the forecast ... to reach USD 301.3 Million by 2021 from USD ...
(Date:5/25/2016)... GERMANTOWN, Maryland , May 25, 2016 /PRNewswire/ ... dringenden Bedarf zur Steuerung ... N.V. (NASDAQ: QGEN ; Frankfurt Prime ... Entwicklungsvereinbarung mit Therawis Diagnostics GmbH zur Entwicklung und ... sein. Ein erstes Projekt wird die Entwicklung und ...
Breaking Medicine Technology:
(Date:5/25/2016)... San Francisco, CA (PRWEB) , ... May 26, 2016 , ... ... 1st, 2016, from 6pm to 7.30pm PST at HP in Palo Alto, CA. This ... panel discussion will be led by clinical trial experts from the pharmaceutical company Hallux, ...
(Date:5/25/2016)... ... May 25, 2016 , ... “We are ... Partner at HealthScape Advisors. “Brad brings significant experience advising healthcare provider clients throughout ... accelerates with the implementation of MACRA, we believe that continuing to add professionals ...
(Date:5/25/2016)... (PRWEB) , ... May 25, 2016 , ... The Georgia ... Award of Excellence from the Atlanta Urban Design Commission. , The annual award recognizes ... city of Atlanta’s built environment, the preservation of its physical heritage and the balance ...
(Date:5/25/2016)... ... 2016 , ... Serenity Recovery, a holistic treatment center for ... the many supplemental program options offered at their rehabilitation facility, this time focusing ... Belt in the Shorin-ryu style of Karate that originated in Okinawa, Japan, and ...
(Date:5/25/2016)... ... ... to an article published May 5th on The Daily Mail, a survey pointed ... it found that more than a third cited unappealing breath a one of their top ... a failure to brush after meals, can typically be attributed to gum disease. Moreover, the ...
Breaking Medicine News(10 mins):