Atorvastatin
Atorvaliq, Atorvastatin, Caduet, Lipitor, Lypqozet (atorvastatin) is a small molecule pharmaceutical. Atorvastatin was first approved as Lipitor on 1996-12-17. It is used to treat coronary artery disease, hypercholesterolemia, hyperlipoproteinemias, and hypertriglyceridemia in the USA. The pharmaceutical is active against 3-hydroxy-3-methylglutaryl-Coenzyme A reductase.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Atorvaliq, Atorvastatin, Lipitor (discontinued: Atorvastatin)
CombinationsAmlodipine besylate atorvastatin, Caduet, Lypqozet (discontinued: Amlodipine besylate atorvastatin, Liptruzet)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Atorvastatin calcium
+
Ezetimibe
Atorvastatin calcium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ATORVALIQ | CMP Pharma | N-213260 RX | 2023-02-01 | 1 products, RLD, RS |
| LIPITOR | Upjohn | N-020702 RX | 1996-12-17 | 4 products, RLD |
Amlodipine besylate
+
Atorvastatin calcium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CADUET | Pharmacia & Upjohn | N-021540 RX | 2004-01-30 | 11 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amlodipine and atorvastatin | NDA authorized generic | 2025-01-03 |
| amlodipine besylate and atorvastatin calcium | ANDA | 2021-02-16 |
| atorvastatin calcium | ANDA | 2025-01-14 |
| caduet | New Drug Application | 2025-01-08 |
| lipitor | New Drug Application | 2024-04-15 |
| lypqozet | ANDA | 2024-01-24 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
ATC Codes
C: Cardiovascular system drugs
— C10: Lipid modifying agents
— C10A: Lipid modifying agents, plain
— C10AA: Hmg coa reductase inhibitors, plain lipid modifying drugs
— C10AA05: Atorvastatin
— C10B: Lipid modifying agents, combinations
— C10BA: Combinations of various lipid modifying agents
— C10BA05: Atorvastatin and ezetimibe
— C10BA08: Atorvastatin and omega-3 fatty acids
— C10BX: Lipid modifying agents in combination with other drugs
— C10BX03: Atorvastatin and amlodipine
— C10BX06: Atorvastatin, acetylsalicylic acid and ramipril
— C10BX08: Atorvastatin and acetylsalicylic acid
— C10BX11: Atorvastatin, amlodipine and perindopril
— C10BX12: Atorvastatin, acetylsalicylic acid and perindopril
— C10BX15: Atorvastatin and perindopril
— C10BX18: Atorvastatin, amlodipine and ramipril
HCPCS
No data
Clinical
Clinical Trials
1097 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypercholesterolemia | D006937 | HP_0003124 | — | 10 | 24 | 88 | 45 | 20 | 187 |
| Dyslipidemias | D050171 | HP_0003119 | — | 10 | 17 | 35 | 38 | 13 | 111 |
| Coronary artery disease | D003324 | — | I25.1 | 3 | 7 | 28 | 51 | 18 | 104 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | 3 | 5 | 24 | 36 | 10 | 76 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | 12 | 13 | 33 | 10 | 9 | 75 |
| Coronary disease | D003327 | — | — | 3 | 3 | 25 | 33 | 7 | 69 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | 3 | 3 | 15 | 25 | 18 | 63 |
| Healthy volunteers/patients | — | — | — | 51 | 1 | — | 6 | 3 | 61 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | 1 | 8 | 12 | 22 | 18 | 60 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 6 | 8 | 13 | 19 | 12 | 57 |
Show 156 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | 1 | 1 | 13 | — | 2 | 17 |
| Covid-19 | D000086382 | — | — | 2 | 2 | 6 | — | 2 | 11 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 4 | 3 | — | 2 | 10 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | 1 | 9 | 7 | — | — | 10 |
| Chronic periodontitis | D055113 | EFO_0006343 | K05.3 | — | 8 | 7 | — | — | 8 |
| Hiv | D006678 | — | — | 1 | 3 | 2 | — | 1 | 6 |
| Cardiotoxicity | D066126 | EFO_1001482 | — | 1 | 6 | 1 | — | — | 6 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 3 | 3 | — | — | 5 |
| Hematoma | D006406 | EFO_0010680 | — | — | 2 | 1 | — | 2 | 5 |
| Leukemia | D007938 | — | C95 | 1 | 4 | 1 | — | — | 5 |
Show 65 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | 4 | — | — | 2 | 7 |
| Sclerosis | D012598 | — | — | 1 | 4 | — | — | 2 | 7 |
| Nephritis | D009393 | — | N05 | — | 3 | — | — | 1 | 4 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | 3 | 2 | — | — | — | 4 |
| Sleep apnea syndromes | D012891 | HP_0010535 | G47.3 | 3 | 2 | — | — | — | 4 |
| Apnea | D001049 | HP_0002104 | R06.81 | 3 | 2 | — | — | — | 4 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 3 | — | — | — | 3 |
| Graft vs host disease | D006086 | — | D89.81 | — | 3 | — | — | — | 3 |
| Lymphoma | D008223 | — | C85.9 | — | 3 | — | — | — | 3 |
| Thromboembolism | D013923 | HP_0001907 | — | 2 | 1 | — | — | — | 3 |
Show 106 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 4 | — | — | — | 1 | 5 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 4 | — | — | — | — | 4 |
| Overweight | D050177 | — | E66.3 | 3 | — | — | — | — | 3 |
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Hereditary nonpolyposis colorectal neoplasms | D003123 | EFO_0007354 | — | 1 | — | — | — | — | 1 |
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | 1 | — | — | — | — | 1 |
| Lipodystrophy | D008060 | HP_0009125 | E88.1 | 1 | — | — | — | — | 1 |
| Hiv seronegativity | D018023 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | — | — | — | — | 1 |
| Sleep wake disorders | D012893 | — | G47 | 1 | — | — | — | — | 1 |
Show 13 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 3 | 3 |
| Rheumatic diseases | D012216 | — | M79.0 | — | — | — | — | 2 | 2 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 2 | 2 |
| Emergence delirium | D000071257 | — | — | — | — | — | — | 2 | 2 |
| Asymptomatic diseases | D058070 | — | — | — | — | — | — | 2 | 2 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 2 | 2 |
| Diastolic heart failure | D054144 | EFO_1000899 | I50.30 | — | — | — | — | 2 | 2 |
| Aortic dissection | D000784 | — | I71.0 | — | — | — | — | 2 | 2 |
| Localized scleroderma | D012594 | EFO_1001361 | L94.0 | — | — | — | — | 1 | 1 |
| Coronary occlusion | D054059 | — | I21 | — | — | — | — | 1 | 1 |
Show 42 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Atorvastatin |
| INN | atorvastatin |
| Description | Atorvastatin is a dihydroxy monocarboxylic acid that is a member of the drug class known as statins, used primarily for lowering blood cholesterol and for preventing cardiovascular diseases. It has a role as an environmental contaminant and a xenobiotic. It is an aromatic amide, a member of monofluorobenzenes, a statin (synthetic), a dihydroxy monocarboxylic acid and a member of pyrroles. It is functionally related to a heptanoic acid. It is a conjugate acid of an atorvastatin(1-). |
| Classification | Small molecule |
| Drug class | enzyme inhibitors: antihyperlipidemics (HMG-CoA inhibitors) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 134523-00-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1487 |
| ChEBI ID | 39548 |
| PubChem CID | 60823 |
| DrugBank | DB01076 |
| UNII ID | A0JWA85V8F (ChemIDplus, GSRS) |
Target
Agency Approved
HMGCR
HMGCR
Organism
Homo sapiens
Gene name
HMGCR
Gene synonyms
NCBI Gene ID
Protein name
3-hydroxy-3-methylglutaryl-Coenzyme A reductase
Protein synonyms
3-hydroxy-3-methylglutaryl CoA reductase (NADPH), HMG-CoA reductase, hydroxymethylglutaryl-CoA reductase
Uniprot ID
Mouse ortholog
Hmgcr (15357)
3-hydroxy-3-methylglutaryl-coenzyme A reductase (Q5U4I2)
Alternate
No data
Variants
No data
Financial
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Liptruzet – Organon
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Caduet – Pfizer
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Lipitor – Viatris
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Lipitor – Pfizer
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Estimated US medical usage
Atorvastatin
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Amlodipine
Total medical expenditures per year (USD, in millions)
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Atorvastatin
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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134,281 adverse events reported
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