Norvasc, Copalia(amlodipine besylate)

Amturnide, Amvaz, Azor, Caduet, Consensi, Copalia, Dafiro, Exforge, Katerzia, Lotrel, Norliqva, Norvasc, Prestalia, Rasilamlo, Rasitrio, Tekamlo, Tribenzor, Twynsta (amlodipine besylate) is a small molecule pharmaceutical. Amlodipine besylate 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 valsartan	ANDA	2023-05-20
amlodipine besylate	ANDA	2023-06-01
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

538 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	42	22	99	119	28	305
Essential hypertension	D000075222		I10	4	10	24	12	5	52
Hyperlipidemias	D006949	EFO_0003774	E78.5	13	1	6	3	—	23
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
Myocardial infarction	D009203	EFO_0000612	I21	—	—	1	—	1	2
Coronary disease	D003327			—	—	1	—	1	2
Hemorrhagic stroke	D000083302			—	—	1	—	—	1

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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	—			66	—	—	—	4	70
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
Erectile dysfunction	D007172	EFO_0004234	F52.21	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 BESYLATE
INN	—
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.O=S(=O)(O)c1ccccc1

Identifiers

PDB	—
CAS-ID	111470-99-6
RxCUI	—
ChEMBL ID	CHEMBL1200402
ChEBI ID	2669
PubChem CID	2162
DrugBank	DB00381
UNII ID	—

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

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Financial

Prestalia - Adhera Therapeutics

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Exforge - Novartis

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Norvasc - Viatris

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Norvasc - Pfizer

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Caduet - Pfizer

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Trends

PubMed Central

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Safety

Black-box Warning

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

Adverse Events

Top Adverse Reactions

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82,698 adverse events reported

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