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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, 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, Teva Pharms, Watson Labs Inc, and Zydus Pharms Usa Inc, and is included in seventeen 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-seven drug master file entries for irbesartan. Seven suppliers are listed for this compound. There are seven tentative approvals for this compound.

Summary for Generic Name: irbesartan

Drug Master File Entries: see list37
Suppliers / Packaging: see list29
Therapeutic Class:Cardiovascular Agents

Pharmacology for Ingredient: irbesartan

Tentative approvals for IRBESARTAN

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

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Status: Withdrawn Condition: Obesity; Hypertension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
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
Dr Reddys Labs Ltd
TABLET;ORAL203161-002Sep 27, 2012RXNo<disabled><disabled>
Alembic Pharms Ltd
TABLET;ORAL091236-003Oct 15, 2012RXNo<disabled><disabled>
Lupin Ltd
TABLET;ORAL201531-002Oct 15, 2012RXNo<disabled><disabled>
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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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