Amlodipine - PharmaKB

Amvaz, Exforge(amlodipine)

Amlodipine, Amlodipine / Valsartan, Amlodipine Besylate, Amlodipine Besylate /, Amlodipine Besylate / Hydrochlorothiazide / Olmesartan Medoxomil, Amlodipine Besylate / Hydrochlorothiazide / Valsartan, Amlodipine Besylate / Olmesartan Medoxomil, Amlodipine Besylate / Valsartan, Amturnide, Amvaz, Azor, Caduet, Consensi, Copalia, Dafiro, Exforge, Katerzia, Lotrel, Norliqva, Norvasc, Prestalia, Rasilamlo, Rasitrio, Tekamlo, Tribenzor, Twynsta (amlodipine) is a small molecule pharmaceutical. Amlodipine was first approved as Norvasc on 1992-07-31. It is used to treat coronary artery disease, hypertension, and variant angina pectoris in the USA. It has been approved in Europe to treat hypertension. 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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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
cardiovascular diseases	D002318
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Katerzia (discontinued: Amlodipine benzoate, Amvaz)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Amlodipine maleate

Tradename	Company	Number	Date	Products
AMVAZ	Dr Reddys Laboratories	N-021435 DISCN	2003-10-31	3 products

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Amlodipine benzoate

Tradename	Company	Number	Date	Products
KATERZIA	Azurity	N-211340 RX	2019-07-08	1 products, RLD, RS

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FDA

EMA

Brand Name	Status	Last Update
amlobenz	ANDA	2010-04-09
amlodipine	ANDA	2013-08-09
amlodipine and atorvastatin	ANDA	2026-02-12
amlodipine and benazepril hydrochloride	ANDA	2026-02-27
amlodipine and benazepril hydrochloride amlodipine besylate	ANDA	2025-01-17
amlodipine and olmesartan medoxomil	ANDA	2026-01-24
amlodipine and olmesartan medoxomil amlodipine and olmesartan medoxomil	ANDA	2025-03-26
amlodipine and valsartan	ANDA	2025-12-30
amlodipine besylate	ANDA	2026-03-04
amlodipine besylate and olmesartran medoxomil	ANDA	2025-08-19

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hypertension	EFO_0000537	D006973	I10
coronary artery disease	—	D003324	I25.1
variant angina pectoris	—	D000788	I20.1

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Amlodipine Besylate, Norliqva, Cmp Dev Llc
11253474	2041-02-24	DP	U-3309, U-3310, U-3311
11458095	2041-02-24	DP	U-3309, U-3310, U-3311
11723866	2041-02-24	DP	U-3309, U-3310, U-3311
Amlodipine Benzoate, Katerzia, Azurity
10799453	2039-04-11	DP
10695329	2037-10-16	DP
10894039	2037-10-06		U-3, U-185
10952998	2037-10-06	DP
10959991	2037-10-06		U-39, U-158
11364230	2037-10-06	DP
11471409	2037-10-06		U-3447, U-3448
11484498	2037-10-06	DP
11701326	2037-10-06	DP
Amlodipine Besylate / Celecoxib, Consensi, Purple Biotech
10350171	2038-06-14	DP
10925835	2038-06-14		U-2410
10945960	2038-06-14	DP
9408837	2030-02-28		U-2410
9662315	2029-05-22	DP	U-2410
Aliskiren Hemifumarate / Amlodipine Besylate, Tekamlo, Novartis
8613949	2029-12-21	DP
Amlodipine Besylate / Perindopril Arginine, Prestalia, Adhera
7846961	2029-10-05	DS, DP	U-3

ATC Codes

C: Cardiovascular system drugs

— C07: Beta-adrenergic blocking agents

— C07F: Beta blocking agents, other combinations

— C07FB: Beta blocking agents and calcium channel blockers

— C07FB07: Bisoprolol and amlodipine

— C07FB12: Nebivolol and amlodipine

— C07FB13: Metoprolol and amlodipine

— C08: Calcium channel blockers

— C08C: Selective calcium channel blockers with mainly vascular effects

— C08CA: Dihydropyridine derivative selective calcium channel blockers with mainly vascular effects

— C08CA01: Amlodipine

— C08CA51: Amlodipine and celecoxib

— C08G: Calcium channel blockers and diuretics

— C08GA: Calcium channel blockers and diuretics

— C08GA02: Amlodipine and diuretics

— C09: Agents acting on the renin-angiotensin system

— C09B: Ace inhibitors, combinations

— C09BB: Ace inhibitors and calcium channel blockers

— C09BB03: Lisinopril and amlodipine

— C09BB04: Perindopril and amlodipine

— C09BB07: Ramipril and amlodipine

— C09BB13: Benazepril and amlodipine

— C09BX: Ace inhibitors, other combinations in atc

— C09BX01: Perindopril, amlodipine and indapamide

— C09BX03: Ramipril, amlodipine and hydrochlorothiazide

— C09BX04: Perindopril, bisoprolol and amlodipine

— C09D: Angiotensin ii receptor blockers (arbs), combinations

— C09DB: Angiotensin ii receptor blockers (arbs) and calcium channel blockers

— C09DB01: Valsartan and amlodipine

— C09DB02: Olmesartan medoxomil and amlodipine

— C09DB04: Telmisartan and amlodipine

— C09DB05: Irbesartan and amlodipine

— C09DB06: Losartan and amlodipine

— C09DB07: Candesartan and amlodipine

— C09DB09: Fimasartan and amlodipine

— C09DX: Angiotensin ii receptor blockers (arbs), other combinations

— C09DX01: Valsartan, amlodipine and hydrochlorothiazide

— C09DX03: Olmesartan medoxomil, amlodipine and hydrochlorothiazide

— C09DX06: Candesartan, amlodipine and hydrochlorothiazide

— C09DX07: Irbesartan, amlodipine and hydrochlorothiazide

— C09DX08: Telmisartan, amlodipine and hydrochlorothiazide

— C09X: Other agents acting on the renin-angiotensin system in atc

— C09XA: Renin-inhibitors

— C09XA53: Aliskiren and amlodipine

— C09XA54: Aliskiren, amlodipine and hydrochlorothiazide

— C10: Lipid modifying agents

— C10B: Lipid modifying agents, combinations

— C10BX: Lipid modifying agents in combination with other drugs

— C10BX03: Atorvastatin and amlodipine

— C10BX07: Rosuvastatin, amlodipine and lisinopril

— C10BX09: Rosuvastatin and amlodipine

— C10BX11: Atorvastatin, amlodipine and perindopril

— C10BX14: Rosuvastatin, amlodipine and perindopril

— C10BX18: Atorvastatin, amlodipine and ramipril

— C10BX19: Atorvastatin, amlodipine and candesartan

HCPCS

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Clinical

Clinical Trials

718 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	58	44	158	183	77	510
Essential hypertension	D000075222	—	I10	5	14	36	23	12	86
Healthy volunteers/patients	—	—	—	73	—	—	1	2	76
Diabetes mellitus	D003920	EFO_0000400	E08-E13	—	1	4	22	7	34
Hyperlipidemias	D006949	EFO_0003774	E78.5	13	1	7	3	—	24
Dyslipidemias	D050171	—	—	5	—	7	8	3	23
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	1	—	2	15	1	19
Cardiovascular diseases	D002318	EFO_0000319	I98	1	2	5	4	4	16
Stroke	D020521	EFO_0000712	I63.9	—	1	3	5	4	13
Hypercholesterolemia	D006937	—	—	—	—	5	5	2	12

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cognitive dysfunction	D060825	—	G31.84	—	3	3	—	3	8
Thalassemia	D013789	EFO_1001996	D56	—	2	3	—	2	5
Beta-thalassemia	D017086	Orphanet_848	D56.1	—	1	2	—	2	4
Iron overload	D019190	—	—	—	1	2	—	2	4
Cerebral hemorrhage	D002543	—	—	—	—	2	—	1	3
Myocardial infarction	D009203	EFO_0000612	I21	—	—	1	—	2	3
Hemorrhage	D006470	MP_0001914	R58	—	—	1	—	1	2
Vascular dementia	D015140	—	F01	—	—	1	—	1	2
Dementia	D003704	EFO_0003862	F03	—	2	1	—	—	2
Follicular lymphoma	D008224	—	C82	—	—	2	—	—	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hiv infections	D015658	EFO_0000764	B20	1	1	—	—	2	4
Ischemia	D007511	EFO_0000556	—	—	1	—	—	1	2
Breast neoplasms	D001943	EFO_0003869	C50	1	2	—	—	—	2
Triple negative breast neoplasms	D064726	—	—	1	2	—	—	—	2
Abdominal aortic aneurysm	D017544	EFO_0004214	—	—	1	—	—	1	2
Aneurysm	D000783	—	I72.9	—	1	—	—	1	2
Aortic aneurysm	D001014	EFO_0001666	I71.9	—	1	—	—	1	2
Vascular diseases	D014652	EFO_0004264	I77	—	1	—	—	1	2
Intracranial hypertension	D019586	EFO_1000992	—	—	1	—	—	—	1
Cerebral infarction	D002544	—	I63	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Malnutrition	D044342	EFO_0008572	E40-E46	5	—	—	—	—	5
Therapeutic equivalency	D013810	—	—	3	—	—	—	—	3
Fasting	D005215	EFO_0002756	—	2	—	—	—	—	2
Hiv	D006678	—	O98.7	1	—	—	—	1	2
Drug interactions	D004347	—	—	1	—	—	—	1	2
Pharmacokinetics	D010599	—	—	1	—	—	—	1	2
Hepatitis c	D006526	—	B19.2	1	—	—	—	—	1
Myotonic dystrophy	D009223	—	G71.11	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Infarction	D007238	EFO_0009463	—	—	—	—	—	2	2
Aging	D000375	GO_0007568	R41.81	—	—	—	—	2	2
Orthostatic hypotension	D007024	—	I95.1	—	—	—	—	1	1
Intracranial arteriosclerosis	D002537	EFO_1000860	I67.2	—	—	—	—	1	1
Delirium	D003693	—	R41.0	—	—	—	—	1	1
Emergence delirium	D000071257	—	—	—	—	—	—	1	1
Renal dialysis	D006435	EFO_0010690	Z99.2	—	—	—	—	1	1
Morbid obesity	D009767	EFO_0001074	—	—	—	—	—	1	1
Medication adherence	D055118	EFO_0006344	—	—	—	—	—	1	1
Infertility	D007246	EFO_0000545	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Amlodipine
INN	amlodipine
Description	Amlodipine is a fully substituted dialkyl 1,4-dihydropyridine-3,5-dicarboxylate derivative, which is used for the treatment of hypertension, chronic stable angina and confirmed or suspected vasospastic angina. It has a role as an antihypertensive agent, a calcium channel blocker and a vasodilator agent. It is a dihydropyridine, a member of monochlorobenzenes, an ethyl ester, a methyl ester and a primary amino compound.
Classification	Small molecule
Drug class	phenylpyridine vasodilators; tricyclic compounds
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1c1ccccc1Cl

Identifiers

PDB	—
CAS-ID	88150-42-9
RxCUI	—
ChEMBL ID	CHEMBL1491
ChEBI ID	2668
PubChem CID	2162
DrugBank	DB00381
UNII ID	1J444QC288 (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

CACNA1D

CACNA1C

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

Q9UDC3

Mouse ortholog

Cacna1d (12289)

voltage-dependent L-type calcium channel subunit alpha-1D (Q99246)

Variants

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Financial

Revenue by drug

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Norvasc – Viatris

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Norvasc – Pfizer

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Prestalia – Adhera Therapeutics

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Exforge – Novartis

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Caduet – Pfizer

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Estimated US medical usage

Amlodipine

Aliskiren

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Amlodipine

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Amlodipine

Atorvastatin

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Amlodipine

Benazepril

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Amlodipine

Hydrochlorothiazide

Olmesartan

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Amlodipine

Hydrochlorothiazide

Valsartan

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Amlodipine

Olmesartan

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Amlodipine

Telmisartan

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Amlodipine

Valsartan

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Trends

PubMed Central

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Safety

Black-box Warning

Black-box warning for: Amlobenz, Amlodipine and benazepril hydrochloride, Amlodipine and olmesartan medoxomil, Amlodipine and olmesartan medoxomil amlodipine and olmesartan medoxomil, Amlodipine and valsartan, Amlodipine besylate and olmesartran medoxomil, Amlodipine besylate and benazepril hcl, Amlodipine besylate and benazepril hydrochloride, Amlodipine besylate and olmesartan medoxomil, Amlodipine besylate and valsartan, Amlodipine, valsartan and hydrochlorothiazide, Amlodipine, valsartan, hydrochlorothiazide, Amlodipine,valsartan and hydrochlorothiazide, Azor, Exforge, Exforge hct, Lotrel, Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide, Olmesartan medoxomil amlodipine and hydrochlorothiazide, Olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide, Olmesartan medoxomil, amlodipine and hydrochlorothiazide, Prestalia, Telmisartan and amlodipine, Tribenzor, Widaplik

Adverse Events

Top Adverse Reactions

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200,244 adverse events reported

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