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Norvir(ritonavir)
Kaletra, Norvir, Paxlovid, Technivie, Viekira, Viekirax (ritonavir) is a small molecule pharmaceutical. Ritonavir was first approved as Norvir on 1996-03-01. It is used to treat acquired immunodeficiency syndrome in the USA. It has been approved in Europe to treat chronic hepatitis c, dna virus infections, and HIV infections. It is known to target cytochrome P450 3A5, cytochrome P450 3A4, and UDP-glucuronosyltransferase 1A1.
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COVID-19
Case Study: COVID-19
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
urogenital diseasesD000091642
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Norvir (generic drugs available since 2015-01-15)
Combinations
Kaletra (generic drugs available since 2015-01-15, discontinued: Technivie, Viekira)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dasabuvir sodium
+
Ombitasvir
+
Paritaprevir
+
Ritonavir
Tradename
Company
Number
Date
Products
VIEKIRA PAK (COPACKAGED)AbbVieN-206619 DISCN2014-12-19
1 products, RLD
VIEKIRA XRAbbVieN-208624 DISCN2016-07-22
1 products, RLD
Hide discontinued
Lopinavir
+
Ritonavir
Tradename
Company
Number
Date
Products
KALETRAAbbVieN-021251 RX2000-09-15
1 products, RLD, RS
KALETRAAbbVieN-021906 RX2005-10-28
2 products, RLD, RS
Show 1 discontinued
Ombitasvir
+
Paritaprevir
+
Ritonavir
Tradename
Company
Number
Date
Products
TECHNIVIEAbbVieN-207931 DISCN2015-07-24
1 products, RLD
Hide discontinued
Ritonavir
Tradename
Company
Number
Date
Products
NORVIRAbbVieN-022417 RX2010-02-10
1 products, RLD, RS
NORVIRAbbVieN-209512 RX2017-06-07
1 products, RLD, RS
Show 3 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
kaletraNew Drug Application2020-10-01
norvirNew Drug Application2020-10-28
paxlovidUse Authorization2021-12-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
acquired immunodeficiency syndromeEFO_0000765D000163B20
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Dasabuvir Sodium / Ombitasvir / Paritaprevir / Ritonavir, Viekira Xr, Abbvie
93332042035-01-02DPU-1889
97441702035-01-02DPU-1889
101053652035-01-02DPU-1889
102015412032-05-17DP
102015842032-05-17U-1889
Dasabuvir Sodium / Ombitasvir / Paritaprevir / Ritonavir, Viekira Pak (Copackaged), Abbvie
96298412033-10-18DPU-1753
102015422033-10-18DPU-1753
84661592032-09-04U-1637
84923862032-09-04U-1840
86801062032-09-04U-1637
86859842032-09-04U-1840
86919382032-04-13DS, DP
86860262031-06-09DP
84205962031-04-10DS, DP
90444802031-04-10U-1638
90063872030-06-10U-1687
86425382029-09-10DS, DPU-1638
81881042029-05-17DS, DPU-1636
85012382028-12-19DS, DPU-1636
91395362028-11-09U-1753
82683492024-08-25DP
83990152024-08-25DP
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AE: Protease inhibitors, direct acting antivirals
— J05AE03: Ritonavir
— J05AP: Antivirals for treatment of hcv infections
— J05AP52: Dasabuvir, ombitasvir, paritaprevir and ritonavir
— J05AP53: Ombitasvir, paritaprevir and ritonavir
— J05AR: Antivirals for treatment of hiv infections, combinations
— J05AR10: Lopinavir and ritonavir
— J05AR23: Atazanavir and ritonavir
— J05AR26: Darunavir and ritonavir
HCPCS
No data
Clinical
Clinical Trials
788 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B2064101817160357
Healthy volunteers/patients—852—6396
HivD006678O98.71581624766
Covid-19D000086382U07.1725188857
Chronic hepatitis cD019698EFO_0004220B18.231884639
Hepatitis cD006526B19.2131172333
InfectionsD007239EFO_000054410872—27
Hiv-1D0154971445—14
Acquired immunodeficiency syndromeD000163EFO_0000765B202128114
TuberculosisD014376EFO_0000774A15-A1934—3312
Show 28 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic hepatitis bD019694EFO_0004197B18.1195—114
MalariaD008288EFO_0001068B544—2——6
Liver cirrhosisD008103EFO_0001422K74.0—13—15
Respiratory distress syndromeD012128EFO_1000637J80131—14
Chronic hepatitis dD019701—21——3
Renal insufficiencyD051437HP_0000083N191—1——2
HepatitisD006505HP_0012115K75.9—11——1
FibrosisD005355——1——1
Breast feedingD001942——1——1
Virus diseasesD014777B34——1——1
Show 3 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GlioblastomaD005909EFO_000051512———2
Drug-related side effects and adverse reactionsD064420T88.711——12
Chronic hepatitisD006521K73.9—2———2
Hepatitis dD003699EFO_0007304—2———2
DiseaseD004194EFO_0000408R69—1———1
ParasitemiaD01851211———1
NeoplasmsD009369C80—1———1
SarcomaD012509—1———1
Mycobacterium avium-intracellulare infectionD015270EFO_0007386—1———1
Liver diseasesD008107EFO_0001421K70-K77—1———1
Show 11 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatic insufficiencyD0485504————4
Biological availabilityD0016824————4
PharmacokineticsD0105992————2
Pulmonary arterial hypertensionD0000810292————2
Substance-related disordersD019966EFO_0003890F131————1
Opioid-related disordersD009293EFO_0005611F111————1
Insulin resistanceD007333EFO_00026141————1
HypertensionD006973EFO_0000537I101————1
Therapeutic equivalencyD0138101————1
Multiple myelomaD009101C90.01————1
Show 18 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Viral pneumoniaD011024EFO_0007541J12.9————22
Wasting syndromeD019282R64————11
Cytokine release syndromeD000080424D89.83————11
Neurobehavioral manifestationsD019954EFO_0004364————11
Medication adherenceD055118EFO_0006344————11
Child behaviorD002652————11
Biliary liver cirrhosisD008105K74.3————11
CoronavirusD017934————11
Hodgkin diseaseD006689C81————11
Retinal diseasesD012164HP_0000479H35.9————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRITONAVIR
INNritonavir
Description
Ritonavir is an L-valine derivative that is L-valinamide in which alpha-amino group has been acylated by a [(2-isopropyl-1,3-thiazol-4-yl)methyl]methylcarbamoyl group and in which a hydrogen of the carboxamide amino group has been replaced by a (2R,4S,5S)-4-hydroxy-1,6-diphenyl-5-{[(1,3-thiazol-5-ylmethoxy)carbonyl]amino}hexan-2-yl group. A CYP3A inhibitor and antiretroviral drug from the protease inhibitor class used to treat HIV infection and AIDS, it is often used as a fixed-dose combination with another protease inhibitor, lopinavir. Also used in combination with dasabuvir sodium hydrate, ombitasvir and paritaprevir (under the trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection as well as cirrhosis of the liver. It has a role as an antiviral drug, a HIV protease inhibitor, an environmental contaminant and a xenobiotic. It is a member of 1,3-thiazoles, a L-valine derivative, a carbamate ester, a member of ureas and a carboxamide.
Classification
Small molecule
Drug classantivirals: HIV protease inhibitors (saquinavir type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(C)c1nc(CN(C)C(=O)N[C@H](C(=O)N[C@@H](Cc2ccccc2)C[C@H](O)[C@H](Cc2ccccc2)NC(=O)OCc2cncs2)C(C)C)cs1
Identifiers
PDB5VEU
CAS-ID155213-67-5
RxCUI85762
ChEMBL IDCHEMBL163
ChEBI ID45409
PubChem CID392622
DrugBankDB00503
UNII IDO3J8G9O825 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CYP3A5
CYP3A5
CYP3A4
CYP3A4
UGT1A1
UGT1A1
Organism
Homo sapiens
Gene name
CYP3A5
Gene synonyms
NCBI Gene ID
1577
Protein name
cytochrome P450 3A5
Protein synonyms
aryl hydrocarbon hydroxylase, CYPIIIA5, cytochrome P450 HLp2, cytochrome P450, family 3, subfamily A, polypeptide 5, cytochrome P450, subfamily IIIA (niphedipine oxidase), polypeptide 5, Cytochrome P450-PCN3, flavoprotein-linked monooxygenase, microsomal monooxygenase, xenobiotic monooxygenase
Uniprot ID
Q9HB56
Mouse ortholog
—
—
Variants
Clinical Variant
No data
Financial
Viekira - AbbVie
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Paxlovid - Pfizer
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Norvir - AbbVie
$
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£
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Kaletra - AbbVie
$
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 36,301 documents
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Safety
Black-box Warning
Black-box warning for: Norvir
Adverse Events
Top Adverse Reactions
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474 adverse events reported
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