FDA Orange Book · active-ingredient family
Amlodipine besylate; hydrochlorothiazide; valsartan
Amlodipine besylate; hydrochlorothiazide; valsartan: 1 brand, 6 generics; first approved Apr 30, 2009; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available — 6 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
6
Listed patents
0
Presentations
35
Originator applications
Brand (NDA) products
EXFORGE HCTRLDNOVARTISNDA 02231420095 strengths
EXFORGE HCTRLD
NOVARTISNDA 02231420095 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 5MG BASE;12.5MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 5MG BASE;25MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 10MG BASE;12.5MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 10MG BASE;25MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 10MG BASE;25MG;320MG | TABLET | ORAL | Rx | AB |
Abbreviated applications
Generic (ANDA) products (6)
MACLEODS PHARMS LTDANDA 20729920255 strengths
MACLEODS PHARMS LTDANDA 20729920255 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 5MG BASE;12.5MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 5MG BASE;25MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 10MG BASE;12.5MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 10MG BASE;25MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 10MG BASE;25MG;320MG | TABLET | ORAL | Rx | AB |
AUROBINDO PHARMAANDA 20618020175 strengths
AUROBINDO PHARMAANDA 20618020175 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 5MG BASE;12.5MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 5MG BASE;25MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 10MG BASE;12.5MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 10MG BASE;25MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 10MG BASE;25MG;320MG | TABLET | ORAL | Rx | AB |
LUPINANDA 20079720155 strengths
LUPINANDA 20079720155 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 5MG BASE;12.5MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 5MG BASE;25MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 10MG BASE;12.5MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 10MG BASE;25MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 10MG BASE;25MG;320MG | TABLET | ORAL | Rx | AB |
TORRENTANDA 20159320155 strengths
TORRENTANDA 20159320155 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 5MG BASE;12.5MG;160MG | TABLET | ORAL | Discontinued | — |
| EQ 5MG BASE;25MG;160MG | TABLET | ORAL | Discontinued | — |
| EQ 10MG BASE;12.5MG;160MG | TABLET | ORAL | Discontinued | — |
| EQ 10MG BASE;25MG;160MG | TABLET | ORAL | Discontinued | — |
| EQ 10MG BASE;25MG;320MG | TABLET | ORAL | Discontinued | — |
STRIDES PHARMA INTLANDA 20108720155 strengths
STRIDES PHARMA INTLANDA 20108720155 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 5MG BASE;12.5MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 5MG BASE;25MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 10MG BASE;12.5MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 10MG BASE;25MG;160MG | TABLET | ORAL | Rx | AB |
| EQ 10MG BASE;25MG;320MG | TABLET | ORAL | Rx | AB |
TEVA PHARMSANDA 20043520125 strengths
TEVA PHARMSANDA 20043520125 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 5MG BASE;12.5MG;160MG | TABLET | ORAL | Discontinued | — |
| EQ 5MG BASE;25MG;160MG | TABLET | ORAL | Discontinued | — |
| EQ 10MG BASE;25MG;160MG | TABLET | ORAL | Discontinued | — |
| EQ 10MG BASE;25MG;320MG | TABLET | ORAL | Discontinued | — |
| EQ 10MG BASE;12.5MG;160MG | TABLET | ORAL | Discontinued | — |
Orange Book patent file
Listed patents
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.
FDA approval span
Approval history
First approval
Apr 30, 2009
17 yr 5 mo ago
Most recent approval
Jan 07, 2025
1 yr 6 mo ago
Approvals span 2009–2025 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Amlodipine besylate; hydrochlorothiazide; 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 BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
