Valsartan - PharmaKB

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

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Commercial

Clinical

Drug

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Variants

Financial

Trends

Safety

Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
urogenital diseases	D000091642
cardiovascular diseases	D002318
endocrine system diseases	D004700

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)

Abbreviated New Drug Application (ANDA)

Hydrochlorothiazide

Valsartan

Tradename	Company	Number	Date	Products
DIOVAN HCT	Novartis	N-020818 RX	1998-03-06	5 products, RLD

Valsartan

Tradename	Company	Number	Date	Products
DIOVAN	Novartis	N-021283 RX	2001-07-18	4 products, RLD, RS

Show 2 discontinued

Sacubitril

Valsartan

Tradename	Company	Number	Date	Products
ENTRESTO SPRINKLE	Novartis	N-218591 RX	2024-04-12	2 products, RLD, RS
ENTRESTO	Novartis	N-207620 RX	2015-07-07	3 products, RLD, RS

Amlodipine besylate

Valsartan

Tradename	Company	Number	Date	Products
EXFORGE	Novartis	N-021990 RX	2007-06-20	4 products, RLD, RS

Amlodipine besylate

Hydrochlorothiazide

Valsartan

Tradename	Company	Number	Date	Products
EXFORGE HCT	Novartis	N-022314 RX	2009-04-30	5 products, RLD, RS

Aliskiren hemifumarate

Valsartan

Tradename	Company	Number	Date	Products
VALTURNA	Novartis	N-022217 DISCN	2009-09-16	2 products

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Nebivolol hydrochloride

Valsartan

Tradename	Company	Number	Date	Products
BYVALSON	AbbVie	N-206302 DISCN	2016-06-03	1 products, RLD

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Labels

FDA

EMA

Brand Name	Status	Last Update
amlodipine and valsartan	ANDA	2024-12-24
amlodipine besylate and valsartan	ANDA	2014-12-16
amlodipine, valsartan and hydrochlorothiazide	ANDA	2024-05-17
amlodipine, valsartan, hydrochlorothiazide	ANDA	2024-06-20
clopidogrel	ANDA	2021-10-12
diovan	New Drug Application	2024-12-20
diovan hct	New Drug Application	2024-12-20
entresto	New Drug Application	2024-07-22
exforge	New Drug Application	2024-12-20
exforge hct	New Drug Application	2024-12-20

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
heart failure	HP_0001635	D006333	I50
diabetic nephropathies	EFO_0000401	D003928	—
hypertension	EFO_0000537	D006973	I10
left ventricular dysfunction	—	D018487	—
coronary artery disease	—	D003324	I25.1
variant angina pectoris	—	D000788	I20.1
nephrotic syndrome	EFO_0004255	D009404	N04
edema	HP_0000969	D004487	R60.9
malignant hypertension	EFO_1001031	D006974	—

Agency Specific

FDA

EMA

Expiration	Code
VALSARTAN, DIOVAN, NOVARTIS
2024-04-19	NPP
SACUBITRIL / VALSARTAN, ENTRESTO, NOVARTIS PHARMS CORP
2024-02-16	M-82
2023-04-01	PED

Patent Expiration

Patent	Expires	Flag	FDA Information
Sacubitril / Valsartan, Entresto, Novartis Pharms Corp
11058667	2036-05-09		U-3170
9517226	2033-08-22		U-3084
9937143	2033-08-22		U-3084
11135192	2033-08-22		U-3084
8877938	2027-05-27	DS, DP
9388134	2026-11-08		U-1723
8101659	2025-01-15	DP
7468390	2023-11-27	DP
8404744	2023-01-14	DP
8796331	2023-01-14		U-1723
Nebivolol Hydrochloride / Valsartan, Byvalson, Abbvie
7838552	2027-10-04		U-185
7803838	2026-08-29	DP
Aliskiren Hemifumarate / Valsartan, Valturna, Novartis
8168616	2026-07-03	DP
Amlodipine Besylate / Hydrochlorothiazide / Valsartan, Exforge Hct, Novartis
8101599	2023-05-16	DP
8475839	2023-05-16	DP

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

532 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypertension	D006973	EFO_0000537	I10	—	—	—	1	—	1
Left ventricular hypertrophy	D017379	EFO_0003896	—	—	—	—	1	—	1
Blood pressure	D001794	EFO_0004325	—	—	—	—	1	—	1
Hypertrophy	D006984	EFO_0002460	—	—	—	—	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 name	Valsartan
INN	valsartan
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 class	angiotensin II receptor antagonists
Image (chem structure or protein)
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-ID	137862-53-4
RxCUI	—
ChEMBL ID	CHEMBL1069
ChEBI ID	9927
PubChem CID	60846
DrugBank	DB00177
UNII ID	80M03YXJ7I (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

CACNA1D

CACNA1C

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

Aliskiren

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Valsartan

Amlodipine

Hydrochlorothiazide

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Valsartan

Amlodipine

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Valsartan

Hydrochlorothiazide

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Valsartan

Sacubitril

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Valsartan

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Trends

PubMed Central

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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, 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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172,931 adverse events reported

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