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Last Updated: July 12, 2020

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AVAPRO Drug Profile


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Which patents cover Avapro, and when can generic versions of Avapro launch?

Avapro is a drug marketed by Sanofi Aventis Us and is included in one NDA.

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

US ANDA Litigation and Generic Entry Outlook for Avapro

A generic version of AVAPRO was approved as irbesartan by TEVA PHARMS on March 30th, 2012.

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Drug patent expirations by year for AVAPRO
Drug Prices for AVAPRO

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Drug Sales Revenue Trends for AVAPRO

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Recent Clinical Trials for AVAPRO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Duke UniversityPhase 1/Phase 2
University of Sierra LeonePhase 1/Phase 2
INC ResearchPhase 1/Phase 2

See all AVAPRO clinical trials

Pharmacology for AVAPRO
Paragraph IV (Patent) Challenges for AVAPRO
Tradename Dosage Ingredient NDA Submissiondate
AVAPRO TABLET;ORAL irbesartan 020757 2004-05-25

US Patents and Regulatory Information for AVAPRO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-001 Sep 30, 1997 AB RX Yes No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-002 Sep 30, 1997 AB RX Yes No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-003 Sep 30, 1997 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for AVAPRO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-003 Sep 30, 1997   Start Trial   Start Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-001 Sep 30, 1997   Start Trial   Start Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-002 Sep 30, 1997   Start Trial   Start Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-002 Sep 30, 1997   Start Trial   Start Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-003 Sep 30, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for AVAPRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0454511 C990006 Netherlands   Start Trial PRODUCT NAME: IRBESARTAN, DESGEWENST IN DE VORM VAN EEN ZOUT EN/OF EEN HYDRAAT, EN HYDROCHLOORTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 - EU/1/98/086/006 19981015
0454511 98C0028 Belgium   Start Trial PRODUCT NAME: IRBESARTAN; NATL. REGISTRATION NO/DATE: EU/1/97/046/001 19970827; FIRST REGISTRATION: CH 54250 02 19970815
0454511 C980039 Netherlands   Start Trial PRODUCT NAME: IRBESARTAN, DESGEWENST IN DE VORM VAN EEN ZOUT EN/OF EEN HYDRAA T; REGISTRATION NO/DATE: EU/1/97/046/001 - 009 19970827
0454511 99C0009 Belgium   Start Trial PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0454511 10/1999 Austria   Start Trial PRODUCT NAME: ''IRBESARTAN'' ZUSAMMEN MIT ''HYDROCHLOROTHIAZID''; REGISTRATION NO/DATE: EU/1/98/086/001 - EU/1/98/086/006 19981015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
McKinsey
McKesson
Merck
Mallinckrodt

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