FDA Orange Book · active-ingredient family
Valsartan
Valsartan is approved as 3 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PREXXARTAN · NDA 209139
3
Brand (NDA)
23
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PREXXARTANRLD | CARMEL BIOSCIENCES | NDA 209139 | — | Dec 19, 2017 | |
| DIOVANRLD×4 | NOVARTIS | NDA 021283 | AB | Aug 14, 2002 | |
| DIOVAN×2 | NOVARTIS | NDA 020665 | — | Dec 23, 1996 |
Generic (ANDA) products (23)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VALSARTAN×4 | LAURUS | ANDA 218897 | AB | Apr 21, 2026 | |
| VALSARTAN | RUBICON RESEARCH | ANDA 216460 | AB | Jun 05, 2025 | |
| VALSARTAN×4 | RENATA | ANDA 218169 | — | Aug 05, 2024 | |
| VALSARTAN×4 | ZYDUS LIFESCIENCES | ANDA 218991 | AB | Jul 22, 2024 | |
| VALSARTAN | NOVITIUM PHARMA | ANDA 214102 | AB | Nov 02, 2021 | |
| VALSARTAN×4 | SCIEGEN PHARMS | ANDA 204038 | AB | Oct 27, 2021 | |
| VALSARTAN×4 | DR REDDYS | ANDA 201618 | AB | Oct 05, 2021 | |
| VALSARTAN×4 | ALKEM LABS LTD | ANDA 205536 | AB | Mar 12, 2019 | |
| VALSARTAN×4 | UNICHEM | ANDA 209261 | — | May 04, 2018 | |
| VALSARTAN×4 | SQUARE PHARMS PLC | ANDA 205347 | AB | Apr 09, 2018 | |
| VALSARTAN×4 | MACLEODS PHARMS LTD | ANDA 202696 | AB | Sep 16, 2016 | |
| VALSARTAN×4 | AMNEAL PHARMS | ANDA 204011 | AB | Jan 11, 2016 | |
| VALSARTAN×4 | IVAX PHARMS | ANDA 077530 | — | Jan 04, 2016 | |
| VALSARTAN×4 | PRINSTON INC | ANDA 204821 | AB | Jun 09, 2015 | |
| VALSARTAN×4 | ALEMBIC | ANDA 091367 | AB | Jan 05, 2015 | |
| VALSARTAN×4 | AUROBINDO PHARMA LTD | ANDA 202223 | AB | Jan 05, 2015 | |
| VALSARTAN×4 | HETERO LABS LTD V | ANDA 203311 | AB | Jan 05, 2015 | |
| VALSARTAN×4 | JUBILANT GENERICS | ANDA 203536 | AB | Jan 05, 2015 | |
| VALSARTAN×4 | LUPIN | ANDA 201677 | — | Jan 05, 2015 | |
| VALSARTAN×4 | MYLAN | ANDA 090866 | AB | Jan 05, 2015 | |
| VALSARTAN×4 | TORRENT | ANDA 202728 | — | Jan 05, 2015 | |
| VALSARTAN×4 | WATSON LABS INC | ANDA 090642 | — | Jan 05, 2015 | |
| VALSARTAN×4 | OHM LABS INC | ANDA 077492 | AB | Jun 26, 2014 |
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.
Valsartan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
