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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Premier Research Consulting, LLC FDA-2025-P-1279 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	Open	Premier Research Consulting

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Avapro (2023)

Total Spending

$3.3M

Total Claims

5,380

Beneficiaries

1,228

Avg Cost/Unit

$8.55

Spending Trend

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

YoY Change:+5.0%

5yr CAGR:+6.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain23 active DMFs18 inactive

22 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

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