Irbesartan

Treats hypertension. Sold as Avapro. Every FDA application for this active ingredient: 1 branded and 23 generic.

As of Nov 15, 2026, FDA lists 24 applications for Irbesartan (sold as Avapro), first approved Sep 30, 1997, with 2 new uses approved and 0 published complete response letters.

First approved: Sep 30, 1997
Applications: 24
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $53.9M
First approved in the EU: Aug 26, 1997
First approved in Japan: Apr 16, 2008

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Irbesartan	Part D	$52.0M	-5%	648,655
Avapro	Part D	$1.9M	-16%	819

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

IRBESARTAN 150 MG TABLET: $0.109 per unitGeneric · -5% in a year
IRBESARTAN 300 MG TABLET: $0.165 per unitGeneric · +7% in a year
IRBESARTAN 75 MG TABLET: $0.084 per unitGeneric · -8% in a year
AVAPRO 150 MG TABLET: $7.34 per unitBrand · 0% in a year
AVAPRO 300 MG TABLET: $8.80 per unitBrand · 0% in a year

Approvals in the EU (EMA)

First approved in the EU 1 month before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Sabervel, genericPharmathen S.A. · Apr 13, 2012 · expired
Irbesartan Teva, genericTeva B.V. · Oct 30, 2009
Ifirmasta (previously Irbesartan Krka), genericKRKA tovarna zdravil d.d. Novo mesto · Dec 1, 2008
Irbesartan Zentiva (previously Irbesartan Winthrop)Zentiva k.s. · Jan 19, 2007
Irbesartan BMSBristol-Myers Squibb Pharma EEIG · Jan 19, 2007 · withdrawn
Aprovel, new substanceSanofi Winthrop Industrie · Aug 26, 1997
KarveaSanofi Winthrop Industrie · Aug 26, 1997

Approvals in Japan (PMDA)

First approved in Japan 127 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Irbetan, new ingredientDrugs containing a new active ingredient indicated for the treatment of hypertension. · Dainippon Sumitomo Pharma Co., Ltd. · Apr 16, 2008

Clinical Trials

12 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney DiseaseChronic Kidney Disease · Jiangsu Hansoh Pharmaceutical Co., Ltd.	Phase 2	Not yet recruiting	Apr 28, 2026
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)Chronic Kidney Disease, Type 2 Diabetes · Baylor Research Institute	Phase 4	Enrolling by invitation	Apr 23, 2026
The Randomized Controlled Study of Shenqi Yishen Granules in the Treatment of IgA NephropathyIgA Nephropathy (IgAN) · Keda Lu	Not applicable	Not yet recruiting	Jan 22, 2026
Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort StudyPost-stroke Pneumonia · First Teaching Hospital of Tianjin University of Traditional Chinese Medicine	—	Not yet recruiting	Dec 4, 2025
Standardized Antihypertensive Treatment ProtocolHypertension · Shanghai Jiao Tong University School of Medicine	Not applicable	Not yet recruiting	Jan 24, 2025
Clinical Trial of Keluoxin Capsules in the Treatment of Diabetic Kidney Disease with Diabetic RetinopathyDiabetic Kidney Disease, Diabetic Retinopathy · Chinese PLA General Hospital	Phase 4	Not yet recruiting	Oct 28, 2024
ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC)ANCA Associated Vasculitis, Cardiovascular Diseases · University of Edinburgh	Phase 2	Active, not recruiting	Nov 29, 2022
Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World StudySacubitril/Valsartan, Hypertension · Beijing Friendship Hospital	—	Recruiting	Aug 12, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 30, 1997	AvaproNDA 20757 · New molecular entity	Sanofi Aventis US	52	Marketed
Mar 30, 2012	IrbesartanANDA 77159	Teva Pharms	4	Marketed
Sep 27, 2012	IrbesartanANDA 77466	Sandoz	5	Marketed
Sep 27, 2012	IrbesartanANDA 79213	Zydus Pharms USA Inc	3	Marketed
Sep 27, 2012	IrbesartanANDA 200461	Pharmobedient	2	Discontinued
Sep 27, 2012	IrbesartanANDA 202910	Hetero Labs Ltd V	6	Marketed
Sep 27, 2012	IrbesartanANDA 203071	Prinston Inc	7	Marketed
Sep 27, 2012	IrbesartanANDA 203081	Aurobindo Pharma Ltd	8	Marketed
Sep 27, 2012	IrbesartanANDA 203161	Chartwell Rx	0	Discontinued
Oct 3, 2012	IrbesartanANDA 202254	Macleods Pharms Ltd	8	Marketed
Oct 12, 2012	IrbesartanANDA 90720	Watson Labs Inc	2	Discontinued
Oct 15, 2012	IrbesartanANDA 90201	Hikma	6	Discontinued
Oct 15, 2012	IrbesartanANDA 91236	Alembic Pharms Ltd	6	Marketed
Oct 15, 2012	IrbesartanANDA 200832	Apotex Inc	2	Discontinued
Oct 15, 2012	IrbesartanANDA 201531	Lupin Ltd	7	Discontinued
Nov 14, 2012	IrbesartanANDA 77205	Chartwell Molecular	2	Marketed
Feb 23, 2015	IrbesartanANDA 203534	Jubilant Generics	4	Marketed
Dec 7, 2015	IrbesartanANDA 203020	Unichem	4	Marketed
Dec 7, 2015	IrbesartanANDA 204774	Sciegen Pharms	3	Marketed
Dec 10, 2015	IrbesartanANDA 203685	Ajanta Pharma Ltd	0	Discontinued
Jun 14, 2016	IrbesartanANDA 206194	Hisun Pharm Hangzhou	5	Marketed
Apr 17, 2018	IrbesartanANDA 204740	Amneal Pharms	4	Marketed
May 22, 2024	IrbesartanANDA 211056	Ipca Labs Ltd	1	Discontinued
Nov 4, 2025	IrbesartanANDA 219539	Msn	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA