FDA Orange Book · active-ingredient family
Irbesartan
Irbesartan: 1 brand, 23 generics; first approved Sep 30, 1997; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 23 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
23
Listed patents
0
Presentations
72
Brand (NDA) products
Originator applications
- AVAPRORLDSANOFI AVENTIS USNDA 02075719973 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB
Generic (ANDA) products (23)
Abbreviated applications
- IRBESARTANMSNANDA 21953920253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - IRBESARTANIPCA LABS LTDANDA 21105620243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - IRBESARTANAMNEAL PHARMSANDA 20474020183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - IRBESARTANHISUN PHARM HANGZHOUANDA 20619420163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - IRBESARTANAJANTA PHARMA LTDANDA 20368520153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - IRBESARTANSCIEGEN PHARMSANDA 20477420153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - IRBESARTANUNICHEMANDA 20302020153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - IRBESARTANJUBILANT GENERICSANDA 20353420153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - IRBESARTANCHARTWELL MOLECULARANDA 07720520123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - IRBESARTANALEMBIC PHARMS LTDANDA 09123620123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - IRBESARTANAPOTEX INCANDA 20083220123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - IRBESARTANHIKMAANDA 09020120123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - IRBESARTANLUPIN LTDANDA 20153120123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - IRBESARTANWATSON LABS INCANDA 09072020123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - IRBESARTANMACLEODS PHARMS LTDANDA 20225420123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - IRBESARTANAUROBINDO PHARMA LTDANDA 20308120123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - IRBESARTANCHARTWELL RXANDA 20316120123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - IRBESARTANHETERO LABS LTD VANDA 20291020123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - IRBESARTANPRINSTON INCANDA 20307120123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - IRBESARTANSANDOZANDA 07746620123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - IRBESARTANYILINGANDA 20046120123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - IRBESARTANZYDUS PHARMS USA INCANDA 07921320123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - IRBESARTANTEVA PHARMSANDA 07715920123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
29 yr 5 mo ago
Most recent approval
11 mo ago
Approvals span 1997–2025 across 24 FDA applications.
Brand (NDA) 14%
Generic (ANDA) 2396%
Irbesartan: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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