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Atorvastatin
Atorvaliq, Caduet, Lipitor, Liptruzet (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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Top 200 Pharmaceuticals by Retail Sales
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Atorvaliq, Lipitor (generic drugs available since 2011-11-30)
Combinations
Caduet (generic drugs available since 2011-11-30, discontinued: Liptruzet)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amlodipine besylate
+
Atorvastatin calcium
Tradename
Company
Number
Date
Products
CADUETPharmacia & UpjohnN-021540 RX2004-01-30
11 products, RLD, RS
Atorvastatin calcium
Tradename
Company
Number
Date
Products
ATORVALIQCMP PharmaN-213260 RX2023-02-01
1 products, RLD, RS
LIPITORUpjohnN-020702 RX1996-12-17
4 products, RLD
Atorvastatin calcium
+
Ezetimibe
Tradename
Company
Number
Date
Products
LIPTRUZETOrganonN-200153 DISCN2013-05-03
4 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
atorvaliqNew Drug Application2023-02-16
atorvastatin calciumANDA2023-06-16
caduetNew Drug Application2021-03-25
lipitorNew Drug Application2021-11-16
lypqozetANDA2021-01-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
coronary artery disease—D003324I25.1
hypercholesterolemiaHP_0003124D006937—
hyperlipoproteinemias—D006951—
hypertriglyceridemiaEFO_0004211D015228—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Atorvastatin Calcium, Atorvaliq, Cmp Dev Llc
113695672037-06-07DP
116541062037-06-07DPU-3612, U-3613
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
825 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypercholesterolemiaD006937HP_000312471759398130
DyslipidemiasD050171HP_00031196112527372
HyperlipidemiasD006949EFO_0003774E78.51010278255
Healthy volunteers/patients—441—6354
Coronary artery diseaseD003324I25.1—210231045
Cardiovascular diseasesD002318EFO_0000319I98—6517735
HypertensionD006973EFO_0000537I1052615432
Type 2 diabetes mellitusD003924EFO_0001360E111—814528
AtherosclerosisD050197EFO_0003914I25.1—1714628
Coronary diseaseD0033271—811—20
Show 92 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50291——11
Prostatic neoplasmsD011471C61142—29
Covid-19D000086382U07.1—25—28
Hyperlipoproteinemia type iiD006938EFO_0004911E78.00——6—17
Chronic periodontitisD055113EFO_0006343K05.3—65——6
HivD006678O98.7121—15
Subdural hematoma chronicD020200—21—14
Myelodysplastic syndromesD009190D46121——4
Myeloid leukemia acuteD015470C92.0121——4
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0—31——4
Show 36 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.8112——25
Obstructive sleep apneaD020181EFO_0003918G47.3332———4
Multiple sclerosisD009103EFO_0003885G35—2——13
CardiotoxicityD066126EFO_1001482—3———3
Mucocutaneous lymph node syndromeD009080EFO_0004246M30.322———3
Balloon angioplasty coronaryD015906EFO_0003951—2——13
Triple negative breast neoplasmsD064726—2———2
Relapsing-remitting multiple sclerosisD020529EFO_0003929—2———2
Colorectal neoplasmsD015179—1——12
AdenocarcinomaD00023011———2
Show 59 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic kidney failureD007676EFO_0003884N18.61———12
PharmacokineticsD0105992————2
InfectionsD007239EFO_00005441———12
Hereditary nonpolyposis colorectal neoplasmsD003123EFO_00073541————1
Autonomic nervous system diseasesD001342EFO_0009532G901————1
LipodystrophyD008060E88.11————1
Hiv seronegativityD0180231————1
EpilepsyD004827EFO_0000474G40.91————1
Sleep wake disordersD012893G471————1
Drug interactionsD0043471————1
Show 5 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Percutaneous coronary interventionD062645————22
Asymptomatic diseasesD058070————22
Diastolic heart failureD054144EFO_1000899I50.30————22
Coronary occlusionD054059I21————11
ProteinuriaD011507HP_0000093R80————11
Inborn genetic diseasesD030342EFO_0000508————11
HypoalphalipoproteinemiasD052456E78.6————11
DeliriumD003693R41.0————11
Altitude sicknessD000532EFO_1000782T70.29————11
Cancer painD000072716G89.3————11
Show 10 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameATORVASTATIN
INNatorvastatin
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 classenzyme 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
PDB1HWK
CAS-ID134523-00-5
RxCUI83367
ChEMBL IDCHEMBL1487
ChEBI ID39548
PubChem CID60823
DrugBankDB01076
UNII IDA0JWA85V8F (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
Clinical Variant
Identifier
Target mutation
Effect
Evaluation
Status
VCV000037346SLCO1B1, 521T>C, Val174Aladrug response2022-02-151A
VCV000017848APOE, 526C>T, Arg176Cysdrug response2021-03-242B
Financial
Lipitor - Viatris
$
€
£
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Lipitor - Pfizer
$
€
£
₣
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Caduet - Pfizer
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 40,489 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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33,308 adverse events reported
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