Norvasc, Copalia(amlodipine)

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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Therapeutic Areas

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

Trade Name

FDA

EMA

Katerzia, Norliqva, Norvasc (generic drugs available since 2007-05-23, discontinued: Amvaz)

Combinations

Azor, Caduet, Exforge, Lotrel, Prestalia, Tribenzor (generic drugs available since 2007-05-23, discontinued: Amturnide, Consensi, Tekamlo, Twynsta)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Aliskiren hemifumarate

Amlodipine besylate

Tradename	Company	Number	Date	Products
TEKAMLO	Novartis	N-022545 DISCN	2010-08-26	4 products

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Aliskiren hemifumarate

Amlodipine besylate

Hydrochlorothiazide

Tradename	Company	Number	Date	Products
AMTURNIDE	Novartis	N-200045 DISCN	2010-12-21	5 products

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Amlodipine benzoate

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

Amlodipine besylate

Tradename	Company	Number	Date	Products
NORLIQVA	CMP Pharma	N-214439 RX	2022-02-24	1 products, RLD, RS
NORVASC	Viatris	N-019787 RX	1992-07-31	3 products, RLD, RS

Show 1 discontinued

Amlodipine besylate

Atorvastatin calcium

Tradename	Company	Number	Date	Products
CADUET	Pharmacia & Upjohn	N-021540 RX	2004-01-30	11 products, RLD, RS

Amlodipine besylate

Benazepril hydrochloride

Tradename	Company	Number	Date	Products
LOTREL	Novartis	N-020364 RX	1995-03-03	6 products, RLD

Amlodipine besylate

Celecoxib

Tradename	Company	Number	Date	Products
CONSENSI	Purple Biotech	N-210045 DISCN	2018-05-31	3 products, RLD

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Amlodipine besylate

Hydrochlorothiazide

Olmesartan medoxomil

Tradename	Company	Number	Date	Products
TRIBENZOR	Cosette Pharmaceuticals	N-200175 RX	2010-07-23	5 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

Amlodipine besylate

Olmesartan medoxomil

Tradename	Company	Number	Date	Products
AZOR	Cosette Pharmaceuticals	N-022100 RX	2007-09-26	4 products, RLD, RS

Amlodipine besylate

Perindopril arginine

Tradename	Company	Number	Date	Products
PRESTALIA	Adhera Therapeutics	N-205003 RX	2015-01-21	3 products, RLD, RS

Amlodipine besylate

Telmisartan

Tradename	Company	Number	Date	Products
TWYNSTA	Boehringer Ingelheim	N-022401 DISCN	2009-10-16	4 products, RLD

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Amlodipine besylate

Valsartan

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

Amlodipine maleate

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

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Labels

FDA

EMA

Brand Name	Status	Last Update
amlodipine and benazepril hydrochloride	ANDA	2023-06-20
amlodipine and valsartan	ANDA	2023-05-20
azor	New Drug Application	2022-06-17
caduet	New Drug Application	2021-03-25
exforge hct	New Drug Application	2022-03-09
katerzia	New Drug Application	2020-10-28
lotrel	New Drug Application	2022-03-09
norliqva	New Drug Application	2022-02-28
norvasc	New Drug Application	2022-04-04
prestalia	New Drug Application	2019-10-25

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
coronary artery disease	—	D003324	I25.1
hypertension	EFO_0000537	D006973	I10
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
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
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
6696481	2023-04-15	DS, DP	U-3
Amlodipine Besylate / Hydrochlorothiazide / Valsartan, Exforge Hct, Novartis
8101599	2023-05-16	DP
8475839	2023-05-16	DP
Aliskiren Hemifumarate / Amlodipine Besylate / Hydrochlorothiazide, Amturnide, Novartis
8183295	2023-05-16	DP

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

— 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

— 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

HCPCS

No data

Clinical

Clinical Trials

544 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	43	22	101	119	28	308
Essential hypertension	D000075222		I10	4	10	24	12	5	52
Hyperlipidemias	D006949	EFO_0003774	E78.5	13	1	7	3	—	24
Dyslipidemias	D050171	HP_0003119		3	—	6	7	1	17
Hypercholesterolemia	D006937	HP_0003124		—	—	3	5	1	9
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	1	—	—	8	—	9
Diabetes mellitus	D003920	EFO_0000400	E08-E13	—	—	2	4	2	8
Blood pressure	D001794	EFO_0004325		—	—	—	7	—	7
Obesity	D009765	EFO_0001073	E66.9	1	2	—	4	1	7
Metabolic syndrome	D024821	EFO_0000195	E88.81	—	1	1	4	1	7

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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	—	2	3	—	—	4
Cerebral hemorrhage	D002543			—	—	2	—	1	3
Beta-thalassemia	D017086	Orphanet_848	D56.1	—	1	1	—	2	3
Heart diseases	D006331	EFO_0003777	I51.9	—	1	1	—	1	3
Vascular dementia	D015140		F01	—	—	1	—	1	2
Iron overload	D019190			—	—	1	—	1	2
Thalassemia	D013789	EFO_1001996	D56	—	1	2	—	—	2
Erectile dysfunction	D007172	EFO_0004234	F52.21	1	—	1	—	—	2
Myocardial infarction	D009203	EFO_0000612	I21	—	—	1	—	1	2
Coronary disease	D003327			—	—	1	—	1	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Insulin resistance	D007333	EFO_0002614		—	1	—	—	1	2
Abdominal aortic aneurysm	D017544	EFO_0004214		—	1	—	—	1	2
Neoplasms	D009369		C80	—	1	—	—	—	1
Abdominal obesity	D056128	HP_0001956		—	1	—	—	—	1
Triple negative breast neoplasms	D064726			1	1	—	—	—	1
Iga vasculitis	D011695	EFO_1000965	D69.0	1	1	—	—	—	1
Hyperaldosteronism	D006929	HP_0011736	E26	—	1	—	—	—	1
Pancreatitis	D010195	EFO_0000278	K85	1	1	—	—	—	1
Dystonic disorders	D020821		G24	—	1	—	—	—	1
Vascular diseases	D014652	EFO_0004264	I77	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—			69	—	—	—	4	73
Therapeutic equivalency	D013810			2	—	—	—	—	2
Hiv infections	D015658	EFO_0000764	B20	1	—	—	—	—	1
Fasting	D005215	EFO_0002756		1	—	—	—	—	1
Hiv	D006678		O98.7	1	—	—	—	—	1
Drug interactions	D004347			1	—	—	—	—	1
Hepatitis c	D006526		B19.2	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Stable angina	D060050		I20.8	—	—	—	—	2	2
Orthostatic hypotension	D007024		I95.1	—	—	—	—	1	1
Renal dialysis	D006435	EFO_0010690	Z99.2	—	—	—	—	1	1
Pharmacokinetics	D010599			—	—	—	—	1	1
Morbid obesity	D009767	EFO_0001074		—	—	—	—	1	1
Infertility	D007246	EFO_0000545		—	—	—	—	1	1
Lung diseases	D008171	EFO_0003818	J98.4	—	—	—	—	1	1
Hyperlipoproteinemia type ii	D006938	EFO_0004911	E78.00	—	—	—	—	1	1
Lower urinary tract symptoms	D059411	EFO_0008008		—	—	—	—	1	1
Diabetes complications	D048909			—	—	—	—	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

Q01668

Mouse ortholog

Cacna1d (12289)

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

Variants

Clinical Variant

No data

Financial

Exforge - Novartis

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Caduet - Pfizer

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Norvasc - Viatris

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Norvasc - Pfizer

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Prestalia - Adhera Therapeutics

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Trends

PubMed Central

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Additional graphs summarizing 19,166 documents

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Safety

Black-box Warning

Black-box warning for: Amlodipine and benazepril hydrochloride, Amlodipine and valsartan, Azor, Exforge hct, Lotrel, Prestalia, Tribenzor

Adverse Events

Top Adverse Reactions

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1,025 adverse events reported

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