Navigation Links
Watson Confirms BYSTOLIC(R) Patent Challenge
Date:3/14/2012

PARSIPPANY, N.J., March 14, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Nebivolol Hydrochloride Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg. Watson's ANDA product is a generic version of Forest Laboratories' BYSTOLIC®, which is a beta-adrenergic blocking agent that is approved for the treatment of hypertension.

Forest Laboratories filed suit against Watson on March 13, 2012, 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 No. 6,545,040.  The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA until June 17, 2015 or 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 BYSTOLIC® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

For the twelve months ending January 31, 2012, BYSTOLIC® had total U.S. sales of approximately $391 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
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. Watson Launches Generic PROMETRIUM(R)
2. Watson to Present at the Barclays Capital 2012 Global Healthcare Conference
3. Watson Receives Complete Response Letter from FDA for Progesterone Vaginal Gel 8%
4. Watson to Present at the 2012 RBC Capital Markets Healthcare Conference
5. Watson to Present at the Citi 2012 Global Healthcare Conference
6. Watson Full Year 2011 Net Revenue Increases 29% to $4.58 Billion;
7. Watson Provides Update on Generic Lidoderm® Application
8. Watson Reaches Settlement with Mallinckrodt Over Exalgo(R)
9. Watson Confirms Court Stays Preliminary Injunction
10. Watson Announces Preliminary 2011 Non-GAAP Earnings of $4.75-$4.77
11. Watson Acquires Ascent Pharmahealth for AU$375 Million
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2014)... 30, 2014 Silicon Valley Bank, the bank ... today that examines the merger, acquisition and IPO ... According to the annual report based on 2013 data, ... since SVB started tracking the data in 2005. ... on solid healthcare M&A activity over the last few ...
(Date:7/30/2014)... and SAN DIEGO , July 30, ... ARNA ) announced today that an article based on ... lorcaserin entitled, "Early Weight Loss While on Lorcaserin, Diet, and ... recently published in the online issue of Obesity , ... objective of these analyses was to identify whether there is ...
(Date:7/30/2014)... NEW YORK , July 30, 2014 ... of new products for oncology supportive care, announced that ... has been featured in an article on OncLive.com titled, ... Head and Neck Cancers."  Dr. Steve Sonis , ... the growing demand seen in the oncology community for ...
Breaking Medicine Technology:Report: Biopharma and Medical Device Companies Beat Historic Investment Returns 2Report: Biopharma and Medical Device Companies Beat Historic Investment Returns 3Eisai and Arena Pharmaceuticals Announce Publication of Post-Hoc Analyses of Lorcaserin Phase 3 Clinical Trial Results in Obesity 2Eisai and Arena Pharmaceuticals Announce Publication of Post-Hoc Analyses of Lorcaserin Phase 3 Clinical Trial Results in Obesity 3Eisai and Arena Pharmaceuticals Announce Publication of Post-Hoc Analyses of Lorcaserin Phase 3 Clinical Trial Results in Obesity 4Eisai and Arena Pharmaceuticals Announce Publication of Post-Hoc Analyses of Lorcaserin Phase 3 Clinical Trial Results in Obesity 5Eisai and Arena Pharmaceuticals Announce Publication of Post-Hoc Analyses of Lorcaserin Phase 3 Clinical Trial Results in Obesity 6Eisai and Arena Pharmaceuticals Announce Publication of Post-Hoc Analyses of Lorcaserin Phase 3 Clinical Trial Results in Obesity 7Access Pharmaceuticals Featured On OncLive.com 2Access Pharmaceuticals Featured On OncLive.com 3
... 2012  A new nationwide survey finds that on ... questions from customers about vitamins and supplements as ... prescription medications.  The study also reveals pharmacists, top ... topics customers do ask about. (Photo: ...
... 2012 Marking a major milestone for the ... developer of oral drug delivery systems, announced today that it ... Patent Office. The patent covers an important part of the ... peptides. Oramed,s portfolio now consists of one issued patent and ...
Cached Medicine Technology:Top OTC Secrets From Your Pharmacist 2Top OTC Secrets From Your Pharmacist 3Top OTC Secrets From Your Pharmacist 4Oramed Pharmaceuticals Granted Australian Patent for Important Part of the Company's Core Technology in Oral Delivery of Proteins 2
(Date:7/30/2014)... (HealthDay News) -- Clues to whether a person is at ... a new study suggests. Chemical changes to a gene ... spur suicidal thoughts and behaviors, the study,s authors explained. Spotting ... to a patient,s risk for suicide, they said. "Suicide ... been stymied in our prevention efforts because we have no ...
(Date:7/30/2014)... digital pathology market was valued at an estimated $250.2 million ... of 11.8%, to reach an estimated $437 million by 2018. ... expected to continue to rise in the coming years as ... pathologists to be efficient and this leads to improved quality ... was valued at $128.9 million and accounted for the largest ...
(Date:7/30/2014)... news release is available in French . ... led by Claude Gronfier (Inserm Unit 846: Stem Cell ... a study under real conditions on the body clocks ... The researchers have shown that a particular kind of ... rhythms are correctly synchronised despite the absence of sunlight. ...
(Date:7/30/2014)... with depression as preschoolers are likely to suffer from ... shows. , Depressed preschoolers were 2.5 times more likely ... school than kids who were not depressed at very ... of Medicine in St. Louis. , Their study is ... Journal of Psychiatry . , "It,s the same old ...
(Date:7/30/2014)... have found that a support program administered entirely ... symptoms in informal caregivers, such as family or ... published online in advance of print in the ... caring for people with Alzheimer,s disease or other ... deal of pressure," said principal investigator Geoffrey Tremont, ...
Breaking Medicine News(10 mins):Health News:Could a Blood Test Predict Suicide Risk? 2Health News:Could a Blood Test Predict Suicide Risk? 3Health News:Global Digital Pathology Market To See 11.8% CAGR to 2018 Says a New Research Report Available at ReportsnReports.com 2Health News:Global Digital Pathology Market To See 11.8% CAGR to 2018 Says a New Research Report Available at ReportsnReports.com 3Health News:Global Digital Pathology Market To See 11.8% CAGR to 2018 Says a New Research Report Available at ReportsnReports.com 4Health News:Global Digital Pathology Market To See 11.8% CAGR to 2018 Says a New Research Report Available at ReportsnReports.com 5Health News:Dimly lit working environments: Correcting your body clock is possible! 2Health News:Dimly lit working environments: Correcting your body clock is possible! 3Health News:Dimly lit working environments: Correcting your body clock is possible! 4Health News:Many depressed preschoolers still suffer in later school years 2Health News:Many depressed preschoolers still suffer in later school years 3Health News:Study: Telephone support program beneficial for caregivers of those with dementia 2
... E-coli 0157, which is a stark eye-opener that adequate measures ... fatal food poisoning infection//. Three fresh cases, not connected to ... in South Lanarkshire, were confirmed yesterday. , ,A warning ... its dangers. But this by no means is to instigate ...
... at an IVF clinic almost destroyed their lives. In an interview ... they had to undergo when they came to know that the ... ,The couple had twins and it was quite obvious that ... by Leeds NHS Trust. "I was physically sick. The thought that ...
... says, as smoking, eating poor diets like too little fish, fruit and vegetables puts human ... ... ,Insufficient consumption of ... European Food Safety Authority, Netherland says. ,Dutch National Institute for Public Health and ...
... of exercise results from an increase in a protein ... and cause cell death. ,A study reports ... inhibits the action of another protein called insulin-like growth ... due to which the result appears. ,In ...
... people have died of heat and hundreds of people suffering ... Punjab province// , Daily Times newspaper reported Monday. ,At ... said. ,Most of the deaths were reported from ... in Multan and 48 degrees in Dera Ghazi Khan and ...
... Gurgaon (Haryana). When millions of disabled people are still dreaming ... has etched out// her own identity as a voice and ... the blind community faces a lot of barriers ranging from ... to be different can help them to overcome all of ...
Cached Medicine News:Health News:Unhealthy Diet Reduces Life Expectancy 2Health News:'Being Disabled Is Not a Barrier to Success' 2
Straight shafts with 1 x 2 teeth. Serrated handle with polished finish. Delicate teeth....
Straight shafts with 0.12 mm teeth and 5 mm tying platform. Serrated handle with polished finish. Manufactured in titanium....
Angled 45 degree shafts with 0.5 teeth and 6 mm tying platform. Polished finish....
Angled 45 degree shafts 8 mm long with 1 x 2 teeth and 5 mm tying platform. Serrated handle with dull finish....
Medicine Products: