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AboutPricing
Drug ReportsDarunavir
Prezista(darunavir)
Darunavir, Prezcobix, Prezista, Rezolsta, Symtuza (darunavir) is a small molecule pharmaceutical. Darunavir was first approved as Prezista on 2006-06-23. 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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Variants
Financial
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Safety
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3M
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Darunavir, Prezista (discontinued: Prezista)
Combinations
Prezcobix, Symtuza
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cobicistat
+
Darunavir
Tradename
Company
Number
Date
Products
PREZCOBIXJohnson & JohnsonN-205395 RX2015-01-29
1 products, RLD, RS
Darunavir
Tradename
Company
Number
Date
Products
PREZISTAJohnson & JohnsonN-021976 RX2008-02-25
4 products, RLD
PREZISTAJohnson & JohnsonN-202895 RX2011-12-16
1 products, RLD, RS
Show 1 discontinued
Cobicistat
+
Darunavir
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
SYMTUZAJohnson & JohnsonN-210455 RX2018-07-17
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
darunavirANDA2025-03-19
darunavir 600 and 800 mgANDA2024-01-18
prezcobixNew Drug Application2024-07-23
prezistaNew Drug Application2024-07-23
symtuzaNew Drug Application2024-07-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
acquired immunodeficiency syndromeEFO_0000765D000163B20
hiv infectionsEFO_0000764D015658B20
chronic hepatitis bEFO_0004239D019694B18.1
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Cobicistat / Darunavir / Emtricitabine / Tenofovir Alafenamide Fumarate, Symtuza, Janssen Prods
107865182038-07-19U-2978
87540652032-08-15DS, DPU-2352, U-2765
92967692032-08-15DS, DPU-2352, U-2765
73907912025-04-17DS, DP
Cobicistat / Darunavir, Prezcobix, Janssen Prods
100397182032-10-06DP
81483742029-09-03DS, DPU-1279, U-2353, U-2364, U-2365, U-2766, U-2767, U-2768, U-2939
77006452026-12-26DS, DP
85189872024-02-16DS, DP
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AE: Protease inhibitors, direct acting antivirals
— J05AE10: Darunavir
— J05AR: Antivirals for treatment of hiv infections, combinations
— J05AR14: Darunavir and cobicistat
— J05AR22: Emtricitabine, tenofovir alafenamide, darunavir and cobicistat
— J05AR26: Darunavir and ritonavir
HCPCS
No data
Clinical
Clinical Trials
285 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_0000764B201295117
Acquired immunodeficiency syndromeD000163EFO_0000765B201162—9
Hiv-1D015497——2—21—5
HivD006678—O98.71—31—5
InfectionsD007239EFO_0000544————2—2
Weight gainD015430—————1—1
Hiv seropositivityD006679—————1—1
Communicable diseasesD003141—————1—1
ViremiaD014766—B34.9———1—1
ObesityD009765EFO_0001073E66.9———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Immunologic deficiency syndromesD007153—D84.91—4——5
PregnancyD011247EFO_0002950Z33.1——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———8————8
MalnutritionD044342EFO_0008572E40-E462————2
Crush injuriesD000071576—T14.81————1
Hiv-2D015498——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDarunavir
INNdarunavir
Description
Darunavir is an N,N-disubstituted benzenesulfonamide bearing an unsubstituted amino group at the 4-position, used for the treatment of HIV infection. A second-generation HIV protease inhibitor, darunavir was designed to form robust interactions with the protease enzyme from many strains of HIV, including those from treatment-experienced patients with multiple resistance mutations to other protease inhibitors. It has a role as a HIV protease inhibitor and an antiviral drug. It is a furofuran, a carbamate ester and a sulfonamide.
Classification
Small molecule
Drug classantivirals: HIV protease inhibitors (saquinavir type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)CN(C[C@@H](O)[C@H](Cc1ccccc1)NC(=O)O[C@H]1CO[C@H]2OCC[C@@H]12)S(=O)(=O)c1ccc(N)cc1
Identifiers
PDB—
CAS-ID206361-99-1
RxCUI—
ChEMBL IDCHEMBL1323
ChEBI ID367163
PubChem CID213039
DrugBankDB01264
UNII IDYO603Y8113 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Darunavir
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 11,845 documents
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Safety
Black-box Warning
Black-box warning for: Darunavir, Symtuza
Adverse Events
Top Adverse Reactions
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15,945 adverse events reported
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