Norvasc, Copalia(amlodipine besylate)
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 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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Commercial
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)
CombinationsAzor, 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)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Aliskiren hemifumarate
+
Amlodipine besylate
Aliskiren hemifumarate
+
Amlodipine besylate
+
Hydrochlorothiazide
Amlodipine benzoate
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
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
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Olmesartan medoxomil
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TRIBENZOR | Cosette Pharmaceuticals | N-200175 RX | 2010-07-23 | 5 products, RLD, RS |
Amlodipine besylate
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Hydrochlorothiazide
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Valsartan
Amlodipine besylate
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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
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 |
|---|---|---|
| amlobenz | ANDA | 2010-04-09 |
| amlodipine | ANDA | 2022-01-28 |
| amlodipine and atorvastatin | ANDA | 2024-08-14 |
| amlodipine and benazepril hydrochloride | ANDA | 2024-07-31 |
| amlodipine and benazepril hydrochloride amlodipine besylate | ANDA | 2021-08-10 |
| amlodipine and olmesartan medoxomil | ANDA | 2024-08-15 |
| amlodipine and valsartan | ANDA | 2024-06-21 |
| amlodipine besylate | ANDA | 2024-08-22 |
| amlodipine besylate and olmesartran medoxomil | ANDA | 2023-01-23 |
| amlodipine besylate and atorvastatin calcium | ANDA | 2021-02-16 |
Show 22 more
Indications
FDA
EMA
No data
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
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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 | 56 | 46 | 156 | 183 | 73 | 503 |
| Essential hypertension | D000075222 | — | I10 | 4 | 14 | 39 | 25 | 13 | 91 |
| Healthy volunteers/patients | — | — | — | 76 | — | — | 1 | 4 | 81 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | 4 | 22 | 7 | 33 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | 13 | 1 | 6 | 3 | — | 23 |
| Dyslipidemias | D050171 | HP_0003119 | — | 5 | — | 6 | 8 | 3 | 22 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | 2 | 14 | 1 | 18 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | 1 | 1 | 5 | 3 | 4 | 14 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | 2 | 6 | 4 | 13 |
| Syndrome | D013577 | — | — | 1 | 4 | 2 | 5 | 1 | 12 |
Show 71 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | 3 | 3 | — | 2 | 7 |
| 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 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 2 | — | 1 | 3 |
| Cerebral hemorrhage | D002543 | — | — | — | — | 2 | — | 1 | 3 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 1 | — | 2 | 3 |
| Infarction | D007238 | EFO_0009463 | — | — | — | 1 | — | 2 | 3 |
| Vascular dementia | D015140 | — | F01 | — | — | 1 | — | 1 | 2 |
| Hemorrhagic stroke | D000083302 | — | — | — | — | 1 | — | — | 1 |
Show 12 more
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 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | 1 | 1 | — | — | 1 | 3 |
| Iga vasculitis | D011695 | EFO_1000965 | D69.0 | 1 | 3 | — | — | — | 3 |
| Purpura | D011693 | HP_0000979 | D69.2 | 1 | 3 | — | — | — | 3 |
| Nephritis | D009393 | — | N05 | 1 | 3 | — | — | — | 3 |
| 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 | HP_0002617 | I72.9 | — | 1 | — | — | 1 | 2 |
| Aortic aneurysm | D001014 | EFO_0001666 | I71.9 | — | 1 | — | — | 1 | 2 |
Show 17 more
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 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | — | — | — | 2 | 2 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 2 | 2 |
| Orthostatic hypotension | D007024 | — | I95.1 | — | — | — | — | 1 | 1 |
| Adrenocortical adenoma | D018246 | — | — | — | — | — | — | 1 | 1 |
| Adrenal gland neoplasms | D000310 | EFO_0003850 | C74 | — | — | — | — | 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 |
Show 23 more
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
CACNA1D
CACNA1C
CACNA1C
Organism
Homo sapiens
Gene name
CACNA1D
Gene synonyms
CACH3, CACN4, CACNL1A2, CCHL1A2
NCBI Gene ID
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
Mouse ortholog
Cacna1d (12289)
voltage-dependent L-type calcium channel subunit alpha-1D (Q99246)
Variants
No data
Financial
Revenue by drug
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Exforge – Novartis
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Prestalia – Adhera Therapeutics
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Caduet – Pfizer
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Norvasc – Viatris
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Norvasc – Pfizer
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Tabular view
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Trends
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Safety
Black-box Warning
Black-box warning for: Amlobenz, Amlodipine and benazepril hydrochloride, 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, Azor, Exforge, Exforge hct, Lotrel, Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide, Olmesartan medoxomil, amlodipine and hydrochlorothiazide, Olmesartan medoxomil, amlodipine and hydrochlorothiazide 20/5/12.5 mg, Olmesartan medoxomil, amlodipine and hydrochlorothiazide 20/5/12.5 mg olmesartan medoxomil, amlodipine and hydrochlorothiazide 40/10/12.5 mg olmesa..., Prestalia, Telmisartan and amlodipine, Tribenzor
Adverse Events
Top Adverse Reactions
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101,296 adverse events reported
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