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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-eight drug master file entries for this compound. Seven suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the irbesartan profile page.

Summary for Tradename: AVAPRO

Patents:1
Applicants:1
NDAs:1
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Status: Withdrawn Condition: Obesity; Hypertension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 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
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-001Sep 30, 1997RXNo6,342,247*PED<disabled> <disabled>
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-002Sep 30, 1997RXNo6,342,247*PED<disabled> <disabled>
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-003Sep 30, 1997RXYes6,342,247*PED<disabled> <disabled>
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Expired Patents for Tradename: AVAPRO

These historical archives are available as an add-on to one-year subscriptions

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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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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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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