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Drug ReportsTenofovir alafenamide
Genvoya(tenofovir alafenamide)
Biktarvy, Descovy, Genvoya, Odefsey, Symtuza, Tenofovir Alafenamide, Vemlidy (tenofovir alafenamide) is a small molecule pharmaceutical. Tenofovir alafenamide was first approved as Genvoya on 2015-11-05. It is used to treat chronic hepatitis b in the USA. It has been approved in Europe to treat hepatitis b and HIV infections.
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EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
urogenital diseasesD000091642
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Vemlidy (generic drugs available since 2023-03-30)
Combinations
Biktarvy, Descovy, Genvoya, Odefsey, Symtuza
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bictegravir sodium
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
BIKTARVYGilead SciencesN-210251 RX2018-02-07
2 products, RLD, RS
Cobicistat
+
Darunavir
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
SYMTUZAJohnson & JohnsonN-210455 RX2018-07-17
1 products, RLD, RS
Cobicistat
+
Elvitegravir
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
GENVOYAGilead SciencesN-207561 RX2015-11-05
1 products, RLD, RS
Emtricitabine
+
Rilpivirine hydrochloride
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
ODEFSEYGilead SciencesN-208351 RX2016-03-01
1 products, RLD, RS
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
DESCOVYGilead SciencesN-208215 RX2016-04-04
2 products, RLD, RS
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
VEMLIDYGilead SciencesN-208464 RX2016-11-10
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
biktarvyNew Drug Application2023-10-31
descovyNew Drug Application2020-12-14
genvoyaNew Drug Application2022-01-13
odefseyNew Drug Application2020-12-15
symtuzaNew Drug Application2023-08-18
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
chronic hepatitis bEFO_0004239D019694B18.1
Agency Specific
FDA
EMA
Expiration
Code
EMTRICITABINE / TENOFOVIR ALAFENAMIDE FUMARATE, DESCOVY, GILEAD SCIENCES INC
2029-01-07ODE-457
2024-09-28ODE-284, ODE-285
BICTEGRAVIR SODIUM / EMTRICITABINE / TENOFOVIR ALAFENAMIDE FUMARATE, BIKTARVY, GILEAD SCIENCES INC
2028-10-07ODE-378
2026-06-18ODE-256
2024-02-24M-82
TENOFOVIR ALAFENAMIDE FUMARATE, VEMLIDY, GILEAD SCIENCES INC
2025-10-17NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Cobicistat / Darunavir / Emtricitabine / Tenofovir Alafenamide Fumarate, Symtuza, Janssen Prods
107865182038-07-19U-2978
100397182032-10-06DP
81483742029-09-03DS, DPU-1279, U-2353, U-2364, U-2365, U-2766, U-2767, U-2768
77006452026-12-26DS, DP
85189872024-02-16DS, DP
Bictegravir Sodium / Emtricitabine / Tenofovir Alafenamide Fumarate, Biktarvy, Gilead Sciences Inc
105488462036-11-08DP
117448022036-11-08DP
97083422035-06-19DS, DP
103850672035-06-19U-257
92169962033-12-19DS, DP
97320922033-12-19DS, DP
87540652032-08-15DS, DPU-257, U-999, U-1259, U-1275, U-1663, U-2352, U-2765
92967692032-08-15DS, DPU-257, U-999, U-1259, U-1275, U-1663, U-2352, U-2765
73907912025-04-17DS, DP
Cobicistat / Elvitegravir / Emtricitabine / Tenofovir Alafenamide Fumarate, Genvoya, Gilead Sciences Inc
86332192030-04-30DPU-257
98912392029-09-03DPU-257
76357042026-10-26DS, DPU-257
89811032026-10-26DS, DP
71762202026-08-27DS, DPU-257
Emtricitabine / Rilpivirine Hydrochloride / Tenofovir Alafenamide Fumarate, Odefsey, Gilead Sciences Inc
71258792025-04-21DS, DPU-257
ATC Codes
J: Antiinfectives for systemic use
J05: Antivirals for systemic use
J05A: Direct acting antivirals
J05AF: Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF13: Tenofovir alafenamide
J05AR: Antivirals for treatment of hiv infections, combinations
J05AR17: Emtricitabine and tenofovir alafenamide
J05AR18: Emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat
J05AR19: Emtricitabine, tenofovir alafenamide and rilpivirine
J05AR20: Emtricitabine, tenofovir alafenamide and bictegravir
J05AR22: Emtricitabine, tenofovir alafenamide, darunavir and cobicistat
HCPCS
No data
Clinical
Clinical Trials
1273 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_0000764B203910814913197499
HivD006678O98.72722407447204
Chronic hepatitis bD019694EFO_0004239B18.11947235052186
Hepatitis bD00650981611201770
Healthy volunteers/patients247233
Acquired immunodeficiency syndromeD000163EFO_0000765B2027143326
Hiv-1D015497279522
InfectionsD007239EFO_0000544693321
TuberculosisD014376EFO_0000774A15-A193323415
Hepatitis cD006526B19.23214413
Show 59 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatocellular carcinomaD006528C22.0268
Covid-19D000086382U07.13527
Metabolic syndromeD024821EFO_0000195E88.8101113
HyperlipidemiasD006949HP_0003077E78.5112
Breast feedingD001942112
Sars-cov-2D000086402122
Hiv seronegativityD0180231112
Liver transplantationD016031EFO_0010682112
B-cell lymphomaD016393112
Chronic hepatitis dD019701112
Show 7 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Contraception behaviorD003268112
Insulin resistanceD007333HP_0000855E88.81922
Heart disease risk factorsD00008274211
Lipid metabolism disordersD05243911
Gender dysphoriaD000068116F6411
TransgenesD01907611
HepacivirusD01617411
Amyotrophic lateral sclerosisD000690HP_0007354G12.2111
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.8111
Lung diseasesD008171HP_0002088J98.411
Show 1 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Risk reduction behaviorD04024233
AgingD000375GO_0007568R41.8133
Sustained virologic responseD00007223022
InflammationD007249MP_000184522
Portal hypertensionD006975EFO_0000666K76.622
Self efficacyD02037722
Pregnancy rateD01887322
Female genital diseasesD005831EFO_0009549N8511
Bone densityD015519EFO_0003923M8511
Job syndromeD007589EFO_0003775D82.411
Show 22 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTenofovir alafenamide
INNtenofovir alafenamide
Description
Tenofovir alafenamide is an L-alanine derivative that is isopropyl L-alaninate in which one of the amino hydrogens is replaced by an (S)-({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methyl)(phenoxy)phosphoryl group. A prodrug for tenofovir, it is used (as the fumarate salt) in combination therapy for the treatment of HIV-1 infection. It has a role as an antiviral drug, a HIV-1 reverse transcriptase inhibitor and a prodrug. It is a L-alanine derivative, a phosphoramidate ester, an ether, a member of 6-aminopurines and an isopropyl ester. It is functionally related to an adenine. It is a conjugate base of a tenofovir alafenamide(1+).
Classification
Small molecule
Drug classantivirals
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)OC(=O)[C@H](C)N[P@](=O)(CO[C@H](C)Cn1cnc2c(N)ncnc21)Oc1ccccc1
Identifiers
PDB
CAS-ID379270-37-8
RxCUI
ChEMBL IDCHEMBL2107825
ChEBI ID
PubChem CID9574768
DrugBankDB09299
UNII IDEL9943AG5J (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Genvoya Gilead Sciences
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Biktarvy Gilead Sciences
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Odefsey Gilead Sciences
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Descovy Gilead Sciences
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Vemlidy Gilead Sciences
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,347 documents
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Safety
Black-box Warning
Black-box warning for: Biktarvy, Descovy, Genvoya, Odefsey, Symtuza
Adverse Events
Top Adverse Reactions
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11,241 adverse events reported
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