Navigation Links
Barr Confirms Patent Challenge of Avodart(R) Soft Gelatin Capsules, 0.5mg
Date:2/26/2008

MONTVALE, N.J., Feb. 26 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by GlaxoSmithKline in connection with its Avodart(R) (dutasteride) soft gelatin capsules, 0.5mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Avodart.

Barr filed its ANDA containing a paragraph IV certification for a generic Avodart product with the U.S. Food & Drug Administration (FDA) in October 2007, and received notification of the application's acceptance for filing in January 2008. Following receipt of the notice from the FDA that Barr's ANDA had been accepted for filing, Barr notified the New Drug Application (NDA) and patent holder.

On February 25, 2008, GlaxoSmithKline filed suit in the U.S. District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.

Avodart (dutasteride) had annual sales of approximately $362 million in the U.S., based on IMS sales data for the twelve-month period ending December 2007.

About Barr Pharmaceuticals, Inc.

Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidi
'/>"/>

SOURCE Barr Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Icahn Confirms Intention to Nominate Three Directors at Biogen
2. Barr Confirms Patent Challenge of Namenda(R) Tablets, 5mg & 10mg
3. Barr Confirms Patent Challenge of Eloxatin(R) Injectable, 5mg/mL
4. Barr Confirms Patent Challenge of Focalin(R) XR
5. Recent Study Confirms Alimentary Healths Bifantis(R) Demonstrates Efficacy in the Treatment of Irritable Bowel Syndrome
6. Study Published in Clinical Cancer Research Confirms Potential Of Peregrines Bavituximab Combined With Radiation In Lung Cancer
7. Barr Confirms Filing an Application With a Paragraph IV Certification for Femcon(R) FE Chewable Oral Contraceptive Product
8. Alexion Acquires All Rights to OMRF Patents Related to Soliris(R)
9. Cephalon Statement on Federal Trade Commission Action Regarding PROVIGIL Patent Settlements
10. United States Patent Office Grants CryoCors Request for Patent Interference
11. AGA Medical Corporation Responds to Occlutech Statement on the Status of the Ongoing Patent Litigation in Europe
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... 11, 2014  Researchers have pioneered a revolutionary ... new technology, called Virtual Finger, allows scientists to ... neurons and synapses using the flat surface of ... 3D imaging studies orders of magnitude more efficient, ... level across many areas of experimental biology. The ...
(Date:7/10/2014)... 10, 2014 Deep Knowledge Ventures ... Forum on ‘Commercialising Longevity Research’ and welcomed a ... the London Bioscience Innovation Center for the event, ... Aging Analytics Ltd. The meeting highlighted the need ... research for age-related disease, as well as the ...
(Date:7/10/2014)... Robert Harman, DVM, Founder and CEO of Vet-Stem, Inc., the ... relaunch of his highly informative blog, now named Stem Cells ... are Stem Cells ?” Dr. Harman’s purpose for blogging ... basics of stem cell therapy so that pet owners can ... when considering regenerative medicine. , A veterinarian by trade, Dr. ...
(Date:7/10/2014)... CROWN POINT, Ind. , July 10, ... recently expanded its use of capnography for ... a growing group of healthcare leaders in ... Capnography measures how effectively patients are breathing ... respiratory depression occurs. By measuring the amount ...
Breaking Biology Technology:Virtual Finger Enables Scientists To Navigate And Analyze 3D Images Of Complex Biological Structures 2Virtual Finger Enables Scientists To Navigate And Analyze 3D Images Of Complex Biological Structures 3DKV Sponsors Forum on Commercialising Longevity Research; Brings Together Scientists, Investors, Entrepreneurs and Celebrities 2DKV Sponsors Forum on Commercialising Longevity Research; Brings Together Scientists, Investors, Entrepreneurs and Celebrities 3DKV Sponsors Forum on Commercialising Longevity Research; Brings Together Scientists, Investors, Entrepreneurs and Celebrities 4DKV Sponsors Forum on Commercialising Longevity Research; Brings Together Scientists, Investors, Entrepreneurs and Celebrities 5DKV Sponsors Forum on Commercialising Longevity Research; Brings Together Scientists, Investors, Entrepreneurs and Celebrities 6Robert Harman, DVM Talks About What Stem Cells are in His Latest Blog Series for Vet-Stem, Inc. 2Robert Harman, DVM Talks About What Stem Cells are in His Latest Blog Series for Vet-Stem, Inc. 3Franciscan St. Anthony Health-Crown Point Underscores Patient Safety Commitment Through Expanded Use of Capnography 2
... position of 15 years as International Purchasing Manager ... Consumer Cables.com. Today Weitz and the four fellow ... at American Consumer Cables oversee one of the ... that provides over 5,000 discounted connectivity product solutions ...
... EVANSTON, Ill. and Exton, Pa., Oct. 12 ... of virtual reality (VR) based medical,simulation systems ... leader,in clinical skills training and evaluation software ... symposium in,Washington D.C., an OEM partnership that ...
... EMERYVILLE, Calif., Oct. 10 Neurobiological,Technologies, Inc. (NTI(R)) (Nasdaq: ... call on Monday, October 13, to provide an update ... ischemic stroke.,Hosting the call will be Paul E. Freiman, ... medical officer., -- Date: Monday, October 13, ...
Cached Biology Technology: Former Cables to Go/Lastar Inc. Employee's Move to Form American Consumer Cables Pays Off 2Mentice, Inc. and Education Management Solutions, Inc. Form OEM Partnership 2Mentice, Inc. and Education Management Solutions, Inc. Form OEM Partnership 3Neurobiological Technologies Announces Update Call on Viprinex (TM) Phase 3 Trial Program 2
(Date:7/14/2014)... a technology that could overcome a major cost ... fuel that could replace expensive and environmentally harmful ... novel catalyst that performs almost as well as ... electric currents to split water molecules into hydrogen ... more efficient than less-expensive catalysts investigated to-date. , ...
(Date:7/14/2014)... ability to reliably and safely make in the laboratory all ... one key step closer to reality. , Writing today in ... University of Wisconsin-Madison stem cell researcher Igor Slukvin reports the ... cells and turning them into both red and the array ... research is important because it identifies how nature itself makes ...
(Date:7/13/2014)... study in women suggests that experiencing one or more ... meal can slow the body,s metabolism, potentially contributing to ... previous day,s stressors before giving them a meal consisting ... scientists then measured their metabolic rate how long ... and took measures of blood sugar, triglycerides, insulin ...
Breaking Biology News(10 mins):Rutgers chemists develop technology to produce clean-burning hydrogen fuel 2Wisconsin scientists find genetic recipe to turn stem cells to blood 2Wisconsin scientists find genetic recipe to turn stem cells to blood 3Weighty issue: Stress and high-fat meals combine to slow metabolism in women 2Weighty issue: Stress and high-fat meals combine to slow metabolism in women 3Weighty issue: Stress and high-fat meals combine to slow metabolism in women 4
... thrown cold water on the idea that planting trees ... Professor Brendan Mackey of Griffith University Climate Change Response ... involving researchers from Australia and the U.K. Their findings ... science and climate change mitigation policy", published in the ...
... the globe issued joint statements today to call world ... can play in the pursuit of sustainable development, and ... drug resistance in infectious agents including tuberculosis. The ... next month,s G8 Summit and other international gatherings later ...
... lift protections for the iconic Hawaiian green sea turtle may ... Stanford researcher. Although the number of Hawaiian green sea ... under the U.S. Endangered Species Act, the population may still ... "It,s critical to compare the animal,s population level to ...
Cached Biology News:Forest and soil carbon is important but does not offset fossil fuel emissions 2Science academies issue 'G-Science' statements to call world leaders' attention to global challenges 2Recovery of Hawaiian green sea turtles still short of historic levels, Stanford-led study suggests 2
Mouse monoclonal antibody to PARK2 - Parkinson disease (autosomal recessive, juvenile) 2, parkin...
... used to quantitate double-stranded DNA (dsDNA) in solution, ... With this kit, DNA is stained with Hoechst ... VersaFluor or other fluorometer. The kit quantitates dsDNA ... to 5 micrograms per ml and contains Hoechst ...
... enterprise-scale sequence analysis software with the DeCypher Engine ... DeCypher, you can perform searches like these from ... NT database in under 6 days ... Use HMM analysis to compare 100,000 ...
...
Biology Products: