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Drug ReportsEmtricitabine
Emtriva(emtricitabine)
/ Emtricitabine / Tenofovir Disoproxil, Biktarvy, Complera, Descovy, Emtricitabine, Emtricitabine / Tenofovir, Emtricitabine / Tenofovir Disoproxil, Emtriva, Eviplera, Genvoya, Odefsey, Stribild, Symtuza, Truvada (emtricitabine) is a small molecule pharmaceutical. Emtricitabine was first approved as Emtriva on 2003-07-02. It is used to treat HIV infections in the USA. It has been approved in Europe to treat HIV infections.
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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
Emtricitabine, Emtriva
Combinations
Biktarvy, Complera, Descovy, Efavirenz, emtricitabine, tenofovir disoproxil, Emtricitabine tenofovir disoproxil, Genvoya, Odefsey, Stribild, Symtuza, Truvada (discontinued: Atripla, Efavirenz; emtricitabine tenofovir disoproxil, Efavirenz; emtricitabine; tenofovir disoproxil, Emtricitabine tenofovir alafenamide, Emtricitabine tenofovir disoproxil)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cobicistat
+
Darunavir
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
SYMTUZAJohnson & JohnsonN-210455 RX2018-07-17
1 products, RLD, RS
Efavirenz
+
Emtricitabine
+
Tenofovir disoproxil fumarate
Tradename
Company
Number
Date
Products
ATRIPLAGilead SciencesN-021937 DISCN2006-07-12
1 products, RLD
Hide discontinued
Bictegravir sodium
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
BIKTARVYGilead SciencesN-210251 RX2018-02-07
2 products, RLD, RS
Emtricitabine
+
Rilpivirine hydrochloride
+
Tenofovir disoproxil fumarate
Tradename
Company
Number
Date
Products
COMPLERAGilead SciencesN-202123 RX2011-08-10
1 products, RLD, RS
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
DESCOVYGilead SciencesN-208215 RX2016-04-04
2 products, RLD, RS
Emtricitabine
Tradename
Company
Number
Date
Products
EMTRIVAGilead SciencesN-021500 RX2003-07-02
1 products, RLD, RS
EMTRIVAGilead SciencesN-021896 RX2005-09-28
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
Cobicistat
+
Elvitegravir
+
Emtricitabine
+
Tenofovir disoproxil fumarate
Tradename
Company
Number
Date
Products
STRIBILDGilead SciencesN-203100 RX2012-08-27
1 products, RLD, RS
Emtricitabine
+
Tenofovir disoproxil fumarate
Tradename
Company
Number
Date
Products
TRUVADAGilead SciencesN-021752 RX2004-08-02
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
atriplaNew Drug Application2024-07-09
atripla accessExport only2021-04-12
biktarvyNew Drug Application2024-10-17
compleraNew Drug Application2024-09-24
complera accessExport only2024-09-23
descovyNew Drug Application2022-01-13
efavirenz, emtricitabine and tenofovir disoproxil fumarateANDA2024-06-27
emtricitabineANDA2024-02-07
emtricitabine and tenofovir disoproxil fumarateANDA2024-10-23
emtricitabine/tdfANDA2023-03-06
Show 8 more
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
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-1259, U-1663, U-2352, U-2765
92967692032-08-15DS, DPU-257, U-1259, U-1663, U-2352, U-2765
73907912025-04-17DS, DP
Emtricitabine / Rilpivirine Hydrochloride / Tenofovir Disoproxil Fumarate, Complera, Gilead Sciences Inc
108571022033-01-14DP
88413102025-12-09DPU-257
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
Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate, Atripla, Gilead Sciences
85981852029-04-28DP
90181922026-06-13U-750, U-1170
95454142026-06-13DPU-750, U-1170
Emtricitabine / Rilpivirine Hydrochloride / Tenofovir Alafenamide Fumarate, Odefsey, Gilead Sciences Inc
71258792025-04-21DS, DPU-257
Cobicistat / Elvitegravir / Emtricitabine / Tenofovir Disoproxil Fumarate, Stribild, Gilead Sciences Inc
85923972024-01-13DPU-248, U-257, U-541, U-750, U-1170
87162642024-01-13DPU-257
94570362024-01-13DPU-257
97441812024-01-13DPU-257
ATC Codes
J: Antiinfectives for systemic use
J05: Antivirals for systemic use
J05A: Direct acting antivirals
J05AF: Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF09: Emtricitabine
J05AR: Antivirals for treatment of hiv infections, combinations
J05AR03: Tenofovir disoproxil and emtricitabine
J05AR06: Emtricitabine, tenofovir disoproxil and efavirenz
J05AR08: Emtricitabine, tenofovir disoproxil and rilpivirine
J05AR09: Emtricitabine, tenofovir disoproxil, elvitegravir and cobicistat
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
801 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_0000764B2038107157140100515
HivD0066781814345839159
Acquired immunodeficiency syndromeD000163EFO_0000765B201327462938145
InfectionsD007239EFO_0000544623342619104
Communicable diseasesD0031414121917958
HepatitisD006505HP_0012115K75.929713635
Immunologic deficiency syndromesD007153HP_0002721D84.918215133
Hepatitis bD006509978326
Hepatitis aD006506EFO_0007305B152657524
Hiv-1D015497279522
Show 78 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic hepatitisD006521K73.95319
Ovarian neoplasmsD010051EFO_0003893C5625118
Covid-19D0000863823617
Ovarian epithelial carcinomaD00007721615117
Renal insufficiencyD051437HP_0000083N19213
Virus diseasesD014777B34213
Breast feedingD001942112
Antibiotic prophylaxisD019072112
Coronavirus infectionsD018352EFO_0007224B34.2122
Sars-cov-2D000086402122
Show 5 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Fallopian tube neoplasmsD0051852315
Gender identityD0057831134
SyndromeD0135771123
Behavior and behavior mechanismsD0015201123
CarcinomaD002277C80.01123
Biliary liver cirrhosisD008105K74.3112
Renal cell carcinomaD002292EFO_00003761112
Respiratory tract infectionsD012141J06.9111
ParasitemiaD018512111
Pulmonary tuberculosisD014397EFO_1000049A1511
Show 25 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Insulin resistanceD007333HP_000085533
Heart disease risk factorsD00008274211
Lipid metabolism disordersD05243911
TransgenesD01907611
Alzheimer diseaseD000544EFO_0000249F0311
DementiaD003704EFO_0003862F0311
Peritoneal neoplasmsD01053411
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypotensionD007022EFO_0005251I9555
Thyroid neoplasmsD013964EFO_000384133
Thyroid diseasesD013959HP_0000820E00-E0733
Spinal anesthesiaD00077522
Cesarean sectionD00258522
Follicular adenocarcinomaD01826322
Septic shockD012772A48.322
Female genital diseasesD005831EFO_0009549N8511
Genital diseasesD00009166211
Sustained virologic responseD00007223011
Show 42 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEmtricitabine
INNemtricitabine
Description
Emtricitabine is an organofluorine compound that is 5-fluorocytosine substituted at the 1 position by a 2-(hydroxymethyl)-1,3-oxathiolan-5-yl group (2R,5S configuration). It is used in combination therapy for the treatment of HIV-1 infection. It has a role as an antiviral drug and a HIV-1 reverse transcriptase inhibitor. It is a pyrimidone, an organofluorine compound, a monothioacetal and a nucleoside analogue.
Classification
Small molecule
Drug classnucleoside antiviral or antineoplastic agents, cytarabine or azarabine derivatives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Nc1nc(=O)n([C@@H]2CS[C@H](CO)O2)cc1F
Identifiers
PDB
CAS-ID143491-57-0
RxCUI
ChEMBL IDCHEMBL885
ChEBI ID31536
PubChem CID60877
DrugBankDB00879
UNII IDG70B4ETF4S (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Stribild Gilead Sciences
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Descovy Gilead Sciences
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Emtriva Gilead Sciences
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Odefsey Gilead Sciences
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Complera Gilead Sciences
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Biktarvy Gilead Sciences
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Truvada Gilead Sciences
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Atripla Gilead Sciences
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Genvoya Gilead Sciences
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Tabular view
Estimated US medical usage
Emtricitabine
+
Efavirenz
+
Tenofovir
Total medical expenditures per year (USD, in millions)
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Emtricitabine
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Emtricitabine
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Rilpivirine
+
Tenofovir
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Emtricitabine
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Tenofovir
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 25,456 documents
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Safety
Black-box Warning
Black-box warning for: Atripla, Atripla access, Biktarvy, Complera, Complera access, Descovy, Efavirenz, emtricitabine and tenofovir disoproxil fumarate, Emtricitabine, Emtricitabine and tenofovir disoproxil fumarate, Emtricitabine/tdf, Emtriva, Genvoya, Odefsey, Stribild, Stribild access, Symtuza, Truvada, Truvada access
Adverse Events
Top Adverse Reactions
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70,250 adverse events reported
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