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Details for Generic Name: irbesartan

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Irbesartan is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Ajanta Pharma Ltd, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cipla Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Roxane, Sandoz, Sciegen Pharms Inc, Teva Pharms, Unichem Labs Ltd, Watson Labs Inc, and Zydus Pharms Usa Inc, and is included in twenty NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are thirty-eight drug master file entries for irbesartan. Seven suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: irbesartan

Tradenames:2
Patents:1
Applicants:20
NDAs:20
Drug Master File Entries: see list38
Suppliers / Packaging: see list29
Therapeutic Class:Cardiovascular Agents

Pharmacology for Ingredient: irbesartan

Tentative approvals for IRBESARTAN

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL150MG; 12.5MG
<disabled><disabled>TABLET; ORAL300MG; 12.5MG
<disabled><disabled>TABLET; ORAL300MG; 25MG

Clinical Trials for: irbesartan

A Bioequivalence Study Comparing Irbesartan/Atorvastatin Combination Tablet With Coadministration of Irbesartan and Atorvastatin
Status: Completed Condition: Healthy

Irbesartan and Adhesion Molecules in AF
Status: Recruiting Condition: Persistent Atrial Fibrillation

Irbesartan Versus Amlodipine: The OBI Study
Status: Withdrawn Condition: Obesity; Hypertension

Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)
Status: Completed Condition: Atrial Fibrillation

A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus
Status: Completed Condition: Type 2 Diabetes Mellitus

Drug Interaction Between Irbesartan and Hydrochlorothiazide
Status: Completed Condition: Healthy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd
IRBESARTAN
irbesartan
TABLET;ORAL203081-001Sep 27, 2012RXNo<disabled><disabled>
Dr Reddys Labs Ltd
IRBESARTAN
irbesartan
TABLET;ORAL203161-001Sep 27, 2012RXNo<disabled><disabled>
Roxane
IRBESARTAN
irbesartan
TABLET;ORAL090201-002Oct 15, 2012RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: irbesartan

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-001Sep 30, 19975,270,317*PED<disabled>
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-003Sep 30, 19975,270,317*PED<disabled>
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-003Sep 30, 19976,342,247*PED<disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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