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Drug ReportsValsartan
Diovan, Copalia(valsartan)
/ Valsartan, Amlodipine / Valsartan, Amlodipine Besylate / Hydrochlorothiazide / Valsartan, Amlodipine Besylate / Valsartan, Copalia, Dafiro, Diovan, Entresto, Exforge, Hydrochlorothiazide / Valsartan, Neparvis, Valsartan, Valturna, Vyduo (valsartan) is a small molecule pharmaceutical. Valsartan was first approved as Diovan on 1996-12-23. It is used to treat diabetic nephropathies, heart failure, hypertension, and left ventricular dysfunction in the USA. It has been approved in Europe to treat heart failure and hypertension. The pharmaceutical is active against type-1 angiotensin II receptor. In addition, it is known to target voltage-dependent L-type calcium channel subunit alpha-1D and voltage-dependent L-type calcium channel subunit alpha-1C.
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Novartis Pharmaceuticals
Searched
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
cardiovascular diseasesD002318
endocrine system diseasesD004700
Trade Name
FDA
EMA
Diovan, Valsartan (discontinued: Diovan, Prexxartan, Valsartan)
Combinations
Amlodipine besylate valsartan, Amlodipine besylate, valsartan hydrochlorothiazide, Diovan, Entresto, Exforge, Sacubitril valsartan, Valsartan hydrochlorothiazide, Vyduo (discontinued: Amlodipine besylate valsartan, Amlodipine besylate, valsartan hydrochlorothiazide, Byvalson, Valsartan hydrochlorothiazide, Valturna)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydrochlorothiazide
+
Valsartan
Tradename
Company
Number
Date
Products
DIOVAN HCTNovartisN-020818 RX1998-03-06
5 products, RLD
Valsartan
Tradename
Company
Number
Date
Products
DIOVANNovartisN-021283 RX2001-07-18
4 products, RLD, RS
Show 2 discontinued
Sacubitril
+
Valsartan
Tradename
Company
Number
Date
Products
ENTRESTO SPRINKLENovartisN-218591 RX2024-04-12
2 products, RLD, RS
ENTRESTONovartisN-207620 RX2015-07-07
3 products, RLD, RS
Amlodipine besylate
+
Valsartan
Tradename
Company
Number
Date
Products
EXFORGENovartisN-021990 RX2007-06-20
4 products, RLD, RS
Amlodipine besylate
+
Hydrochlorothiazide
+
Valsartan
Tradename
Company
Number
Date
Products
EXFORGE HCTNovartisN-022314 RX2009-04-30
5 products, RLD, RS
Aliskiren hemifumarate
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Valsartan
Tradename
Company
Number
Date
Products
VALTURNANovartisN-022217 DISCN2009-09-16
2 products
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Nebivolol hydrochloride
+
Valsartan
Tradename
Company
Number
Date
Products
BYVALSONAbbVieN-206302 DISCN2016-06-03
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
amlodipine and valsartanANDA2025-11-06
amlodipine besylate and valsartanANDA2014-12-16
amlodipine, valsartan and hydrochlorothiazideANDA2024-05-17
amlodipine, valsartan, hydrochlorothiazideANDA2025-06-02
amlodipine,valsartan and hydrochlorothiazideANDA2025-01-09
clopidogrelANDA2021-10-12
diovanNew Drug Application2025-07-21
diovan hctNew Drug Application2024-12-20
entrestoNew Drug Application2025-10-29
exforgeNew Drug Application2025-04-02
Show 7 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
heart failureEFO_0003144D006333I50
diabetic nephropathiesEFO_0000401D003928—
hypertensionEFO_0000537D006973I10
left ventricular dysfunction—D018487—
coronary artery disease—D003324I25.1
variant angina pectoris—D000788I20.1
nephrotic syndromeEFO_0004255D009404N04
edema—D004487R60.9
malignant hypertensionEFO_1001031D006974—
Agency Specific
FDA
EMA
Expiration
Code
VALSARTAN, DIOVAN, NOVARTIS
2024-04-19NPP
SACUBITRIL / VALSARTAN, ENTRESTO, NOVARTIS PHARMS CORP
2024-02-16M-82
2023-04-01PED
Patent Expiration
Patent
Expires
Flag
FDA Information
Sacubitril / Valsartan, Entresto, Novartis Pharms Corp
110586672036-05-09U-3170
95172262033-08-22U-3084
99371432033-08-22U-3084
111351922033-08-22U-3084
88779382027-05-27DS, DP
93881342026-11-08U-1723
81016592025-01-15DP
74683902023-11-27DP
84047442023-01-14DP
87963312023-01-14U-1723
Nebivolol Hydrochloride / Valsartan, Byvalson, Abbvie
78385522027-10-04U-185
78038382026-08-29DP
Aliskiren Hemifumarate / Valsartan, Valturna, Novartis
81686162026-07-03DP
Amlodipine Besylate / Hydrochlorothiazide / Valsartan, Exforge Hct, Novartis
81015992023-05-16DP
84758392023-05-16DP
ATC Codes
C: Cardiovascular system drugs
— C09: Agents acting on the renin-angiotensin system
— C09C: Angiotensin ii receptor blockers (arbs), plain
— C09CA: Angiotensin ii receptor blockers (arbs), plain
— C09CA03: Valsartan
— C09D: Angiotensin ii receptor blockers (arbs), combinations
— C09DA: Angiotensin ii receptor blockers (arbs) and diuretics
— C09DA03: Valsartan and diuretics
— C09DB: Angiotensin ii receptor blockers (arbs) and calcium channel blockers
— C09DB01: Valsartan and amlodipine
— C09DB08: Valsartan and lercanidipine
— C09DX: Angiotensin ii receptor blockers (arbs), other combinations
— C09DX01: Valsartan, amlodipine and hydrochlorothiazide
— C09DX02: Valsartan and aliskiren
— C09DX04: Valsartan and sacubitril
— C09DX05: Valsartan and nebivolol
— C10: Lipid modifying agents
— C10B: Lipid modifying agents, combinations
— C10BX: Lipid modifying agents in combination with other drugs
— C10BX10: Rosuvastatin and valsartan
HCPCS
No data
Clinical
Clinical Trials
542 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10———1—1
Left ventricular hypertrophyD017379EFO_0003896————1—1
Blood pressureD001794EFO_0004325————1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameValsartan
INNvalsartan
Description
Valsartan is a monocarboxylic acid amide consisting of L-valine in which the amino hydrogens have been replaced by a pentanoyl and a [2'-(1H-tetrazol-5-yl)biphenyl]-4-yl]methyl group. It exhibits antihypertensive activity. It has a role as an antihypertensive agent, an angiotensin receptor antagonist, a xenobiotic and an environmental contaminant. It is a biphenylyltetrazole, a monocarboxylic acid amide and a monocarboxylic acid.
Classification
Small molecule
Drug classangiotensin II receptor antagonists
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCCCC(=O)N(Cc1ccc(-c2ccccc2-c2nnn[nH]2)cc1)[C@H](C(=O)O)C(C)C
Identifiers
PDB—
CAS-ID137862-53-4
RxCUI—
ChEMBL IDCHEMBL1069
ChEBI ID9927
PubChem CID60846
DrugBankDB00177
UNII ID80M03YXJ7I (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CACNA1D
CACNA1D
CACNA1C
CACNA1C
NOTUM
NOTUM
Organism
Homo sapiens
Gene name
CACNA1D
Gene synonyms
CACH3, CACN4, CACNL1A2, CCHL1A2
NCBI Gene ID
776
Protein name
voltage-dependent L-type calcium channel subunit alpha-1D
Protein synonyms
calcium channel, L type, alpha-1 polypeptide, Calcium channel, L type, alpha-1 polypeptide, isoform 2, calcium channel, neuroendocrine/brain-type, alpha 1 subunit, calcium channel, voltage-dependent, L type, alpha 1D subunit, voltage-gated calcium channel alpha 1 subunit, voltage-gated calcium channel alpha subunit Cav1.3, Voltage-gated calcium channel subunit alpha Cav1.3
Uniprot ID
Q01668
Mouse ortholog
Cacna1d (12289)
voltage-dependent L-type calcium channel subunit alpha-1D (Q99246)
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Diovan – Novartis
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Entresto – Novartis
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Exforge – Novartis
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Estimated US medical usage
Valsartan
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Aliskiren
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Refill frequency
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Valsartan
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Amlodipine
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Hydrochlorothiazide
Total medical expenditures per year (USD, in millions)
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Valsartan
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Amlodipine
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Valsartan
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Hydrochlorothiazide
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Valsartan
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Sacubitril
Total medical expenditures per year (USD, in millions)
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Valsartan
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 21,476 documents
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Safety
Black-box Warning
Black-box warning for: Amlodipine and valsartan, Amlodipine besylate and valsartan, Amlodipine, valsartan and hydrochlorothiazide, Amlodipine, valsartan, hydrochlorothiazide, Amlodipine,valsartan and hydrochlorothiazide, Clopidogrel, Diovan, Diovan hct, Entresto, Exforge, Exforge hct, Prexxartan, Sacubitril and valsartan, Valsartan, Valsartan and hydrochlorothiazide, Valsartan/htcz
Adverse Events
Top Adverse Reactions
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176,839 adverse events reported
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