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Profile for Tradename: AVAPRO

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Avapro is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from seven suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in AVAPRO is irbesartan. There are thirty-seven drug master file entries for this compound. Seven suppliers are listed for this compound. There are seven tentative approvals for this compound. Additional details are available on the irbesartan profile page.

Summary for Tradename: AVAPRO

Suppliers / Packagers: see list29

Pharmacology for Tradename: AVAPRO

Clinical Trials for: AVAPRO

Effectiveness of Avapro in Obese Normotensive/Hypertensive African Americans
Status: Recruiting Condition: Hypertension; Obesity

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

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

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

Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension
Status: Completed Condition: Hypertension

Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension
Status: Completed Condition: Hypertension

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Status: Withdrawn Condition: Obesity; Hypertension

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

Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan
Status: Completed Condition: Kidney Failure, Chronic

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
Sanofi Aventis Us
TABLET;ORAL020757-001Sep 30, 1997RXNo6,342,247*PED<disabled>Y<disabled>
Sanofi Aventis Us
TABLET;ORAL020757-002Sep 30, 1997RXNo6,342,247*PED<disabled>Y<disabled>
Sanofi Aventis Us
TABLET;ORAL020757-003Sep 30, 1997RXYes6,342,247*PED<disabled>Y<disabled>
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Paragraph IV activity for: AVAPRO

Drugname Dosage Strength RLD Submissiondate
irbesartanTablets75 mg, 150 mg and 300 mgAvapro5/25/2004

Non-Orange Book Patents for Tradename: AVAPRO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,994,348 Pharmaceutical compositions containing irbesartan<disabled in preview>
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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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