FDA Orange Book · active-ingredient family
Irbesartan
Irbesartan is approved as 1 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AVAPRO · NDA 020757
1
Brand (NDA)
23
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AVAPRORLD×3 | SANOFI AVENTIS US | NDA 020757 | — | Sep 30, 1997 |
Generic (ANDA) products (23)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IRBESARTAN×3 | MSN | ANDA 219539 | AB | Nov 04, 2025 | |
| IRBESARTAN×3 | IPCA LABS LTD | ANDA 211056 | — | May 22, 2024 | |
| IRBESARTAN×3 | AMNEAL PHARMS | ANDA 204740 | AB | Apr 17, 2018 | |
| IRBESARTAN×3 | HISUN PHARM HANGZHOU | ANDA 206194 | AB | Jun 14, 2016 | |
| IRBESARTAN×3 | AJANTA PHARMA LTD | ANDA 203685 | — | Dec 10, 2015 | |
| IRBESARTAN×3 | SCIEGEN PHARMS | ANDA 204774 | AB | Dec 07, 2015 | |
| IRBESARTAN×3 | UNICHEM | ANDA 203020 | AB | Dec 07, 2015 | |
| IRBESARTAN×3 | JUBILANT GENERICS | ANDA 203534 | AB | Feb 23, 2015 | |
| IRBESARTAN×3 | CHARTWELL MOLECULAR | ANDA 077205 | AB | Nov 14, 2012 | |
| IRBESARTAN×3 | ALEMBIC PHARMS LTD | ANDA 091236 | AB | Oct 15, 2012 | |
| IRBESARTAN×3 | APOTEX INC | ANDA 200832 | — | Oct 15, 2012 | |
| IRBESARTAN×3 | HIKMA | ANDA 090201 | — | Oct 15, 2012 | |
| IRBESARTAN×3 | LUPIN LTD | ANDA 201531 | — | Oct 15, 2012 | |
| IRBESARTAN×3 | WATSON LABS INC | ANDA 090720 | — | Oct 12, 2012 | |
| IRBESARTAN×3 | MACLEODS PHARMS LTD | ANDA 202254 | AB | Oct 03, 2012 | |
| IRBESARTAN×3 | AUROBINDO PHARMA LTD | ANDA 203081 | AB | Sep 27, 2012 | |
| IRBESARTAN×3 | CHARTWELL RX | ANDA 203161 | — | Sep 27, 2012 | |
| IRBESARTAN×3 | HETERO LABS LTD V | ANDA 202910 | AB | Sep 27, 2012 | |
| IRBESARTAN×3 | PRINSTON INC | ANDA 203071 | AB | Sep 27, 2012 | |
| IRBESARTAN×3 | SANDOZ | ANDA 077466 | AB | Sep 27, 2012 | |
| IRBESARTAN×3 | YILING | ANDA 200461 | — | Sep 27, 2012 | |
| IRBESARTAN×3 | ZYDUS PHARMS USA INC | ANDA 079213 | AB | Sep 27, 2012 | |
| IRBESARTAN×3 | TEVA PHARMS | ANDA 077159 | AB | Mar 30, 2012 |
Listed patents
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.
Irbesartan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
