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Last Updated: March 28, 2024

AVAPRO Drug Patent 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-one suppliers are listed for this compound. Additional details are available on the irbesartan profile page.

DrugPatentWatch® 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
University of Sierra LeonePhase 1/Phase 2
INC ResearchPhase 1/Phase 2
University of North CarolinaPhase 1/Phase 2

See all AVAPRO clinical trials

Pharmacology for AVAPRO
Paragraph IV (Patent) Challenges for AVAPRO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AVAPRO Tablets irbesartan 75 mg, 150 mg and 300 mg 020757 1 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-002 Sep 30, 1997 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-003 Sep 30, 1997 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 020757-001 Sep 30, 1997 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-003 Sep 30, 1997 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-001 Sep 30, 1997 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-003 Sep 30, 1997 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-002 Sep 30, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for AVAPRO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Sanofi Winthrop Industrie Karvea irbesartan EMEA/H/C/000142
Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal product regimen.
Authorised no no no 1997-08-26
Sanofi Winthrop Industrie Aprovel irbesartan EMEA/H/C/000141
Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen.
Authorised no no no 1997-08-26
Zentiva k.s. Irbesartan Zentiva (previously Irbesartan Winthrop) irbesartan EMEA/H/C/000785
Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen.
Authorised no no no 2007-01-19
Teva B.V. Irbesartan Teva irbesartan EMEA/H/C/001093
Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.
Authorised yes no no 2009-10-30
Krka, d.d., Novo mesto Ifirmasta (previously Irbesartan Krka) irbesartan EMEA/H/C/000962
Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.
Authorised yes no no 2008-12-01
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for AVAPRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0454511 99C0009 Belgium ⤷  Try a Trial PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0454511 SPC/GB98/037 United Kingdom ⤷  Try a Trial PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE) (GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS.; REGISTERED: CH 54 250.02 19970815; UK EU/1/97/046/001 19970827; UK EU/1/97/046/002 19970827; UK EU/1/97/046/003 19970827; UK EU/1/97/046/004 19970827; UK EU/1/97/046/005 19970827; UK EU/1/97/046/006 19970827; UK EU/1/97/046/007 19970827; UK EU/1/97/046/008 19970827; UK EU/1/97/046/009 19970827
0454511 C990006 Netherlands ⤷  Try a 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 ⤷  Try a Trial PRODUCT NAME: IRBESARTAN; NATL. REGISTRATION NO/DATE: EU/1/97/046/001 19970827; FIRST REGISTRATION: CH 54250 02 19970815
0454511 10/1999 Austria ⤷  Try a 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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