Viewing data from:

AVAPRO

NDA

IRBESARTAN | N020757 | SANOFI AVENTIS US LLC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Premier Research Consulting, LLC FDA-2025-P-1279 · 5 docket documents Premier Research Consulting, LLC filed this ANDA Suitability Petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA confirmation that Irbesartan Oral Suspension is suitable for submission in an ANDA. The proposed liquid suspension product at 150 mg per 5	Suitability	2025-05-16	Granted	Premier Research Consulting, LLC
Lupin Pharmaceutical, Inc. - Citizen Petition FDA-2012-P-0279 · 3 docket documents Lupin Pharmaceuticals, Inc. filed this petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA formally determine that Teva Pharmaceuticals has forfeited its 180-day marketing exclusivity for generic versions of Avapro brand irbesartan tablets in 75 mg, 150	505(q)	2012-04-03	Denied	—
Aurobindo Pharmaceuticals Ltd., (EAS Consulting Group, LLC) - Citizen Petition FDA-2011-P-0743 · 4 docket documents Aurobindo Pharmaceuticals Limited, through EAS Consulting Group LLC, filed this citizen petition on October 11, 2011, requesting that the FDA determine whether Avalide (irbesartan and hydrochlorothiazide) Tablets in the 300 and 25 mg strength, approved under NDA 20-758 and manufactured by Sanofi Ave	505(q)	2011-10-21	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

87 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 66 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy NCT03762850	Phase 3	Active	Travere Therapeutics, Inc.	406	2018-12-11 → 2026-07
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients NCT02817360	Phase 4	Recruiting	Martin Huelsmann	2,400	2016-02 → 2026-12
The Efficacy and Safety of Irbesartan 150/12.5 mg and 300/25 mg in Patients With Mild Hypertension NCT00562809	Phase 4	Completed	Sanofi	1,005	2003-07 → 2004-08
Irbesartan, Ciprofibrate and Their Combination Onto the Endothelial Functions NCT00350038	Phase 4	Completed	Sanofi	60	2005-02 → 2007-08
Irbesartan and Amlodipine Combination in Controlling Blood Pressure NCT00950066	Phase 2	Completed	Sanofi	270	2009-07 → 2010-01
I PREVENT - Irbesartan In Hypertensive Diabetic Patients NCT00362258	Phase 4	Completed	Sanofi	797	2006-02 → 2008-09
I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy NCT00362037	Phase 4	Completed	Sanofi	281	2006-03 → 2008-06
Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients NCT00670566	Phase 4	Completed	Sanofi	503	2008-04
Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan NCT00791830	Phase 3	Completed	University of Aarhus	82	2009-04 → 2013-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$8.80

per ea

Lowest NADAC/Unit

$7.35

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00024585230AVAPRO 300 MG TABLET	$8.80	EA	Brand	$0.1530	2026-06-17
00024585130AVAPRO 150 MG TABLET	$7.35	EA	Brand	$0.1111	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$167.03

Highest Price

$277.49

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00024-5852-30AVAPRO 300MG TABLETS	$277.49	FSS	Sanofi Aventis U.S. LLC	05/31/2028
00024-5852-30AVAPRO 300MG TABLETS	$202.24	Big4	Sanofi Aventis U.S. LLC	05/31/2028
00024-5851-30AVAPRO 150MG TABLETS	$230.79	FSS	Sanofi Aventis U.S. LLC	05/31/2028
00024-5851-30AVAPRO 150MG TABLETS	$167.03	Big4	Sanofi Aventis U.S. LLC	05/31/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Avapro (2024)

Total Spending

$2.3M

Total Claims

3,829

Beneficiaries

992

Avg Cost/Unit

$8.17

Spending Trend

$5.0M(2019)→$4.6M(2020)→$4.2M(2021)→$3.4M(2022)→$3.3M(2023)→$2.3M(2024)

YoY Change:-4.5%

5yr CAGR:+3.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain24 active DMFs18 inactive

23 active API suppliers hold Drug Master Files for this ingredient.

SANOFI CHIMIEIRBESARTAN DRUG SUBSTANCE

DMF 103101993

TAPI NL BVIRBESARTAN

DMF 173942004

HETERO LABS LTDIRBESARTAN (FORM A) PROCESS I

DMF 175072004

MATRIX PHARMACORP PRIVATE LTDIRBESARTAN USP

DMF 179122004

EUROAPI HUNGARY LTDIRBESARTAN DRUG SUBSTANCE

DMF 196902006

JUBILANT BIOSYS LTDIRBESARTAN USP

DMF 197902006

DR REDDYS LABORATORIES LTDIRBESARTAN USP

DMF 200082006

ZYDUS LIFESCIENCES LTDIRBESARTAN USP

DMF 203612007

ALEMBIC PHARMACEUTICALS LTDIRBESARTAN USP

DMF 203782007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDIRBESARTAN USP

DMF 217802008

APITORIA PHARMA PRIVATE LTDIRBESARTAN USP (NON-STERILE DRUG SUBSTANCE)

DMF 230842009

MACLEODS PHARMACEUTICALS LTDIRBESARTAN

DMF 234492010

UNICHEM LABORATORIES LTDIRBESARTAN USP

DMF 238352010

CALYX CHEMICALS AND PHARMACEUTICALS LTDIRBESARTAN

DMF 240172010

CTX LIFE SCIENCES PVT LTDIRBESARTAN USP

DMF 245962011

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDIRBESARTAN API

DMF 247522011

MICRO LABS LTDIRBESARTAN USP

DMF 248342011

TAPI NL BVIRBESARTAN USP

DMF 254832011

ULKAR KIMYA SANAYII VE TICARET ASIRBESARTAN USP

DMF 258612012

PIRAMAL PHARMA LTDIRBESARTAN

DMF 266842012

ZHUHAI RUNDU PHARMACEUTICAL CO LTDIRBESARTAN, NON-STERILE BULK DRUG SUBSTANCE

DMF 328032019

MSN LIFE SCIENCES PRIVATE LTDIRBESARTAN USP

DMF 360682021

SYNERGENE ACTIVE INGREDIENTS PRIVATE LTDIRBESARTAN USP

DMF 389562023

DIVIS LABORATORIES LTDIRBESARTAN USP

DMF 390962023

SA AJINOMOTO OMNICHEM NVInactiveIRBESARTAN CRUDE

DMF 128701998

BRISTOL MYERS SQUIBB COInactiveIRBESARTAN

DMF 128821998

BRISTOL MYERS SQUIBB COInactiveIRBESARTAN

DMF 132651998

BASF PHARMA EVIONNAZ SAInactiveIRBESARTAN(SR47436)

DMF 154062001

RANBAXY LABORATORIES LTDInactiveIRBESARTAN USP

DMF 177962004

QUIMICA SINTETICA SAInactiveIRBESARTAN

DMF 187462005

USV PRIVATE LTDInactiveIRBESARTAN USP

DMF 201482007

CIPLA LTDInactiveIRBESARTAN

DMF 201762008

LUPIN LTDInactiveIRBESARTAN USP

DMF 201982007

CADILA PHARMACEUTICALS LTDInactiveIRBESARTAN (POLYMORPHIC FORM-A)

DMF 213692007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDInactiveIRBESARTAN

DMF 217542008

SIGNA SA DE CVInactiveIRBESARTAN USP

DMF 233472009

LUPIN LTDInactiveIRBESARTAN USP (PROCESS B)

DMF 233982010

HETERO LABS LTDInactiveIRBESARTAN (FORM A) PROCESS II

DMF 246652011

CADILA HEALTHCARE LTDInactiveIRBESARTAN USP

DMF 254462011

ZHUHAI RUNDU PHARMACEUTICAL CO LTDInactiveIRBESARTAN

DMF 255092011

DIVIS LABORATORIES LTDInactiveIRBESARTAN USP

DMF 264182012

HEC PHARM CO LTDInactiveIRBESARTAN NON-STERILE BULK DRUG SUBSTANCE

DMF 268022013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Aug 5, 2025	SUPPL -80	View Letter (PDF)
Sep 14, 2021	SUPPL -74	View Letter (PDF)
May 12, 2021	SUPPL -75	View Letter (PDF)
Dec 16, 2020	SUPPL -71	View Letter (PDF)
Jul 23, 2018	SUPPL -69	View Letter (PDF)
Feb 9, 2016	SUPPL -59	View Letter (PDF)
Feb 9, 2016	SUPPL -67	View Letter (PDF)
Jun 2, 2014	SUPPL -64	View Letter (PDF)
Sep 14, 2012	SUPPL -60	View Letter (PDF)
Jan 23, 2012	SUPPL -58	View Letter (PDF)
Dec 14, 2011	SUPPL -56	View Letter (PDF)
Aug 2, 2011	SUPPL -55	View Letter (PDF)
Apr 25, 2006	SUPPL -38	View Letter (PDF)
Mar 23, 2006	SUPPL -39	View Letter (PDF)
Nov 30, 2005	SUPPL -37	View Letter (PDF)
Sep 20, 2002	SUPPL -21	View Letter (PDF)
Jul 19, 2002	SUPPL -22	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 75MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 30, 1997

No patent or exclusivity listings for this strength.

#002 — 150MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 30, 1997

#003 — 300MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 30, 1997