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Drug ReportsLopinavir
Kaletra(lopinavir)
Kaletra, Lopinavir / Ritonavir, Lopinavir/Ritonavir Mylan (lopinavir) is a small molecule pharmaceutical. Lopinavir was first approved as Kaletra on 2000-09-15. It is used to treat acquired immunodeficiency syndrome in the USA. It has been approved in Europe to treat HIV infections.
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COVID-19
Case Study: COVID-19
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Combinations
Kaletra, Lopinavir ritonavir (discontinued: Kaletra)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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
Labels
FDA
EMA
Brand Name
Status
Last Update
kaletraNew Drug Application2023-07-06
lopinavir and ritonavirANDA2023-10-20
lopinavir-ritonavirANDA2020-11-18
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AR: Antivirals for treatment of hiv infections, combinations
— J05AR10: Lopinavir and ritonavir
HCPCS
No data
Clinical
Clinical Trials
435 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_0000764B202464817161283
Acquired immunodeficiency syndromeD000163EFO_0000765B2061221191973
Covid-19D000086382—U07.11222752065
HivD006678—O98.710910201560
InfectionsD007239EFO_0000544—4915111048
Immunologic deficiency syndromesD007153—D84.922104925
Coronavirus infectionsD018352EFO_0007224B34.2—872923
Communicable diseasesD003141———557420
PneumoniaD011014EFO_0003106J18—332915
TuberculosisD014376EFO_0000774A15-A1936—4114
Show 26 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatitis cD006526—B19.2222—39
HepatitisD006505—K75.9—22—37
Virus diseasesD014777—B34—13—37
Severe acute respiratory syndromeD045169EFO_0000694J12.81—13—25
Respiratory distress syndromeD012128EFO_1000637J80111—35
Hepatitis aD006506EFO_0007305B15—11—24
SyndromeD013577——111—24
Hiv-2D015498————1——1
Breast feedingD001942————1——1
Respiratory tract infectionsD012141—J06.9——1——1
Show 1 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Viral pneumoniaD011024EFO_0007541J12.9—1——34
CoronavirusD017934———1——23
Hepatitis bD006509———1——12
Liver cirrhosisD008103EFO_0001422K74.0—1——12
FibrosisD005355———1——12
Disease progressionD018450——11———2
NeoplasmsD009369—C8011———2
Renal insufficiencyD051437—N19—1———1
ViremiaD014766—B34.9—1———1
DiseaseD004194EFO_0000408R69—1———1
Show 16 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Insulin resistanceD007333EFO_0002614E88.8192———13
PharmacokineticsD010599——1———12
Long qt syndromeD008133HP_0001657I45.811————1
Pharmacological phenomenaD000069437——1————1
Therapeutic equivalencyD013810——1————1
HypertriglyceridemiaD015228EFO_0004211—1————1
Carcinoma in situD002278—D09.91————1
Squamous intraepithelial lesions of the cervixD065310——1————1
TherapeuticsD013812——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetes mellitusD003920EFO_0000400E08-E13————22
Chronic hepatitis cD019698EFO_0004220B18.2————11
Chronic hepatitis bD019694EFO_0004239B18.1————11
Wasting syndromeD019282——————11
CachexiaD002100—R64————11
HemorrhageD006470MP_0001914R58————11
Heart failureD006333EFO_0003144I50————11
HypertensionD006973EFO_0000537I10————11
MenorrhagiaD008595EFO_0003945N92.0————11
Hemophilia aD006467EFO_0007267D66————11
Show 38 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLopinavir
INNlopinavir
Description
Lopinavir is a dicarboxylic acid diamide that is amphetamine is substituted on nitrogen by a (2,6-dimethylphenoxy)acetyl group and on the carbon alpha- to nitrogen by a (1S,3S)-1-hydroxy-3-{[(2S)-3-methyl-2-(2-oxotetrahydropyrimidin-1-yl)butanoyl]amino}-4-phenylbutyl group. An antiretroviral of the protease inhibitor class, it is used against HIV infections as a fixed-dose combination with another protease inhibitor, ritonavir. It has a role as an antiviral drug, a HIV protease inhibitor and an anticoronaviral agent. It is a member of amphetamines and a dicarboxylic acid diamide.
Classification
Small molecule
Drug classantivirals: HIV protease inhibitors (saquinavir type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1cccc(C)c1OCC(=O)N[C@@H](Cc1ccccc1)[C@@H](O)C[C@H](Cc1ccccc1)NC(=O)[C@H](C(C)C)N1CCCNC1=O
Identifiers
PDB—
CAS-ID192725-17-0
RxCUI—
ChEMBL IDCHEMBL729
ChEBI ID31781
PubChem CID92727
DrugBankDB01601
UNII ID2494G1JF75 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Kaletra – AbbVie
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Estimated US medical usage
Lopinavir
+
Ritonavir
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 27,995 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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21,439 adverse events reported
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