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AboutPricing
Drug ReportsRosuvastatin
Rosuvastatin
Crestor, Rosuvastatin, Roszet (rosuvastatin) is a small molecule pharmaceutical. Rosuvastatin was first approved as Crestor on 2003-08-12. It is used to treat coronary artery disease, hypercholesterolemia, hyperlipoproteinemias, and hypertriglyceridemia in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Crestor, Rosuvastatin (discontinued: Ezallor, Rosuvastatin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Rosuvastatin calcium
Tradename
Company
Number
Date
Products
CRESTORAstraZenecaN-021366 RX2003-08-12
4 products, RLD, RS
Show 1 discontinued
Ezetimibe
+
Rosuvastatin calcium
Tradename
Company
Number
Date
Products
ROSZETAlthera PharmaceuticalN-213072 DISCN2021-03-23
4 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
crestorNew Drug Application2026-04-29
rosuvastatinANDA2026-09-04
rosuvastatin calciumANDA2026-09-21
rosuvastatin rosuvastatin calciumANDA2026-03-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hypercholesterolemia—D006937—
coronary artery disease—D003324I25.1
hypertriglyceridemiaEFO_0004211D015228—
hyperlipoproteinemias—D006951—
familial combined hyperlipidemiaEFO_0000492D006950E78.49
hyperlipoproteinemia type iiEFO_0004911D006938E78.00
Agency Specific
FDA
EMA
Expiration
Code
ROSUVASTATIN CALCIUM, CRESTOR, IPR
2023-05-27ODE-118
Patent Expiration
Patent
Expires
Flag
FDA Information
Rosuvastatin Calcium, Ezallor Sprinkle, Sun Pharm
104135432036-02-12DP
Ezetimibe / Rosuvastatin Calcium, Roszet, Althera Pharms
97638852033-05-01DPU-3095
103764702033-05-01DPU-3095
ATC Codes
A: Alimentary tract and metabolism drugs
— A10: Drugs used in diabetes
— A10B: Blood glucose lowering drugs, excl. insulins
— A10BH: Dipeptidyl peptidase 4 (dpp-4) inhibitors for blood glucose lowering
— A10BH52: Gemigliptin and rosuvastatin
C: Cardiovascular system drugs
— C10: Lipid modifying agents
— C10A: Lipid modifying agents, plain
— C10AA: Hmg coa reductase inhibitors, plain lipid modifying drugs
— C10AA07: Rosuvastatin
— C10B: Lipid modifying agents, combinations
— C10BA: Combinations of various lipid modifying agents
— C10BA06: Rosuvastatin and ezetimibe
— C10BA07: Rosuvastatin and omega-3 fatty acids
— C10BA09: Rosuvastatin and fenofibrate
— C10BX: Lipid modifying agents in combination with other drugs
— C10BX05: Rosuvastatin and acetylsalicylic acid
— C10BX07: Rosuvastatin, amlodipine and lisinopril
— C10BX09: Rosuvastatin and amlodipine
— C10BX10: Rosuvastatin and valsartan
— C10BX13: Rosuvastatin, perindopril and indapamide
— C10BX14: Rosuvastatin, amlodipine and perindopril
— C10BX16: Rosuvastatin and fimasartan
— C10BX17: Rosuvastatin and ramipril
HCPCS
No data
Clinical
Clinical Trials
901 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypercholesterolemiaD006937——322571047
DyslipidemiasD050171——52112625
AtherosclerosisD050197EFO_0003914I25.12234—11
HyperlipidemiasD006949EFO_0003774E78.51323211
Coronary artery diseaseD003324—I25.11142210
Coronary diseaseD003327————3238
Diabetes mellitusD003920EFO_0000400E08-E13—2—248
Myocardial ischemiaD017202EFO_1001375I20-I25——2125
Heart diseasesD006331EFO_0003777I51.9—11125
Hyperlipoproteinemia type iiD006938EFO_0004911E78.00——41—5
Show 20 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart failureD006333EFO_0003144I50—13——4
Homozygous familial hypercholesterolemiaD000090542————2——2
Renal insufficiencyD051437—N191—1——2
StrokeD020521EFO_0000712I63.9——1—12
Hyperlipoproteinemia type iiiD006952————1——1
Kidney diseasesD007674EFO_0003086N08——1——1
RecurrenceD012008————1——1
Cerebrovascular disordersD002561EFO_0003763I60-I69——1——1
Cerebral infarctionD002544—I63——1——1
Venous thrombosisD020246—I82.40——1——1
Show 6 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InflammationD007249MP_0001845—12———3
Craniocerebral traumaD006259—S0012———2
AmnesiaD000647EFO_1001454F44.012———2
Spatial orientationD000072458——12———2
ProteinuriaD011507—R80—2———2
Amyloid plaqueD058225———1———1
DepressionD003863—F33.9—1———1
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———13———114
Rheumatoid arthritisD001172EFO_0000685M06.91————1
ArthritisD001168EFO_0005856M05-M141————1
NeoplasmsD009369—C801————1
Non-small-cell lung carcinomaD002289——1————1
PharmacokineticsD010599——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Peripheral vascular diseasesD016491EFO_0003875I73.9————22
Vascular diseasesD014652EFO_0004264I77————11
Peripheral arterial diseaseD058729EFO_0004265—————11
ObservationD019370——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRosuvastatin
INNrosuvastatin
Description
Rosuvastatin is a dihydroxy monocarboxylic acid that is (6E)-7-{4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-(propan-2-yl)pyrimidin-5-yl} hept-6-enoic acid carrying two hydroxy substituents at positions 3 and 5 (the 3R,5S-diastereomer). It has a role as an antilipemic drug, an anti-inflammatory agent, a CETP inhibitor, a cardioprotective agent, a xenobiotic and an environmental contaminant. It is a member of pyrimidines, a sulfonamide, a dihydroxy monocarboxylic acid, a statin (synthetic) and a member of monofluorobenzenes. It is functionally related to a hept-6-enoic acid. It is a conjugate acid of a rosuvastatin(1-).
Classification
Small molecule
Drug classenzyme inhibitors: antihyperlipidemics (HMG-CoA inhibitors)
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Structure (InChI/SMILES or Protein Sequence)
CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Identifiers
PDB—
CAS-ID287714-41-4
RxCUI—
ChEMBL IDCHEMBL1496
ChEBI ID38545
PubChem CID446157
DrugBankDB01098
UNII ID413KH5ZJ73 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
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Crestor – AstraZeneca
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Estimated US medical usage
Rosuvastatin
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 9,999 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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44,661 adverse events reported
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