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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, 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 sixteen 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 five tentative approvals for this compound.

Summary for Generic Name: irbesartan

Drug Master File Entries: see list37
Suppliers: see list7
Therapeutic Class:Cardiovascular Agents

Pharmacology for Ingredient: irbesartan

Tentative approvals for IRBESARTAN

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

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

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

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Status: Withdrawn Condition: Obesity; Hypertension

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
Apotex Inc
TABLET;ORAL200832Oct 15, 2012RXNo<disabled><disabled>
Watson Labs Inc
TABLET;ORAL090720Oct 12, 2012RXNo<disabled><disabled>
Mylan Pharms Inc
TABLET;ORAL200461Sep 27, 2012RXNo<disabled><disabled>
Prinston Inc
TABLET;ORAL203071Sep 27, 2012RXNo<disabled><disabled>
Lupin Ltd
TABLET;ORAL201531Oct 15, 2012RXNo<disabled><disabled>
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