FDA Orange Book · active-ingredient family
Valsartan
Valsartan: 3 brands, 24 generics; first approved Dec 23, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 24 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
24
Listed patents
0
Presentations
97
Brand (NDA) products
Originator applications
- PREXXARTANRLDCARMEL BIOSCIENCESNDA 2091392017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG/ML SOLUTION ORAL Rx AB - DIOVANRLDNOVARTISNDA 02128320024 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - NOVARTISNDA 02066519962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG CAPSULE ORAL Discontinued — 160MG CAPSULE ORAL Discontinued —
Generic (ANDA) products (24)
Abbreviated applications
- VALSARTANBOSTAL DRUGANDA 20535720264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG TABLET ORAL Rx AB - VALSARTANLAURUSANDA 21889720264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG TABLET ORAL Rx AB - VALSARTANRUBICON RESEARCHANDA 2164602025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG/ML SOLUTION ORAL Rx AB - VALSARTANRENATAANDA 21816920244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — 160MG TABLET ORAL Discontinued — 320MG TABLET ORAL Discontinued — - VALSARTANZYDUS LIFESCIENCESANDA 21899120244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG TABLET ORAL Rx AB - VALSARTANRSNOVITIUM PHARMAANDA 2141022021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG/ML SOLUTION ORAL Rx AB - VALSARTANSCIEGEN PHARMSANDA 20403820214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG TABLET ORAL Rx AB - VALSARTANDR REDDYSANDA 20161820214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG TABLET ORAL Rx AB - VALSARTANALKEM LABS LTDANDA 20553620194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG TABLET ORAL Rx AB - VALSARTANUNICHEMANDA 20926120184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — 160MG TABLET ORAL Discontinued — 320MG TABLET ORAL Discontinued — - VALSARTANSQUARE PHARMS PLCANDA 20534720184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG TABLET ORAL Rx AB - VALSARTANMACLEODS PHARMS LTDANDA 20269620164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG TABLET ORAL Rx AB - VALSARTANAMNEAL PHARMSANDA 20401120164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG TABLET ORAL Rx AB - VALSARTANIVAX PHARMSANDA 07753020164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — 160MG TABLET ORAL Discontinued — 320MG TABLET ORAL Discontinued — - VALSARTANPRINSTON INCANDA 20482120154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG TABLET ORAL Rx AB - VALSARTANALEMBICANDA 09136720154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG TABLET ORAL Rx AB - VALSARTANAUROBINDO PHARMA LTDANDA 20222320154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG TABLET ORAL Rx AB - VALSARTANHETERO LABS LTD VANDA 20331120154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG TABLET ORAL Rx AB - VALSARTANJUBILANT GENERICSANDA 20353620154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG TABLET ORAL Rx AB - VALSARTANLUPINANDA 20167720154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — 160MG TABLET ORAL Discontinued — 320MG TABLET ORAL Discontinued — - VALSARTANMYLANANDA 09086620154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG TABLET ORAL Rx AB - VALSARTANTORRENTANDA 20272820154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — 160MG TABLET ORAL Discontinued — 320MG TABLET ORAL Discontinued — - VALSARTANWATSON LABS INCANDA 09064220154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — 160MG TABLET ORAL Discontinued — 320MG TABLET ORAL Discontinued — - VALSARTANOHM LABS INCANDA 07749220144 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB 320MG 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
30 yr 2 mo ago
Most recent approval
1 mo ago
Approvals span 1996–2026 across 27 FDA applications.
Brand (NDA) 311%
Generic (ANDA) 2489%
Valsartan: 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.
