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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 alafenamide, Emtricitabine tenofovir disoproxil, Emtricitabine, rilpivirine 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 Application2017-01-23
atripla accessExport only2021-04-12
biktarvyNew Drug Application2024-10-17
compleraNew Drug Application2024-09-24
complera accessExport only2024-09-23
descovyNew Drug Application2025-01-30
efavirenz, emtricitabine and tenofovir disoproxil fumarateANDA2024-06-27
emtricitabineANDA2024-02-07
emtricitabine and tenofovir disoproxil fumarateANDA2025-06-03
emtricitabine, rilpivirine, tenofovir disoproxil fumarateANDA2024-12-14
Show 9 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hiv infectionsEFO_0000764D015658B20
hiv—D006678O98.7
acquired immunodeficiency syndromeEFO_0000765D000163B20
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
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
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
73907912025-01-07DS, 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
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
818 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_0000764B2039109157143102522
HivD006678—O98.71814345941162
Acquired immunodeficiency syndromeD000163EFO_0000765B201429462939148
InfectionsD007239EFO_0000544—724342620106
Communicable diseasesD003141——41219171059
HepatitisD006505—K75.929713736
Immunologic deficiency syndromesD007153—D84.919215134
Hepatitis bD006509———978326
Hepatitis aD006506EFO_0007305B152657524
Hiv-1D015497——2795—22
Show 81 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic hepatitisD006521—K73.9—53—19
Ovarian neoplasmsD010051EFO_0003893C56251—18
Covid-19D000086382—U07.1—36—17
Ovarian epithelial carcinomaD000077216——151—17
Renal insufficiencyD051437—N19—21——3
Virus diseasesD014777—B34——2—13
Metabolic syndromeD024821EFO_0000195E88.810——1—23
Breast feedingD001942————1—12
Antibiotic prophylaxisD019072——1—1——2
Coronavirus infectionsD018352EFO_0007224B34.2—12——2
Show 5 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Fallopian tube neoplasmsD005185——23——15
Gender identityD005783——11——34
SyndromeD013577——11——23
Behavior and behavior mechanismsD001520——11——23
CarcinomaD002277—C80.011——23
Biliary liver cirrhosisD008105—K74.3—1——12
Renal cell carcinomaD002292EFO_0000376—11——12
NeoplasmsD009369—C80—1——12
Respiratory tract infectionsD012141—J06.911———1
ParasitemiaD018512——11———1
Show 25 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Insulin resistanceD007333EFO_0002614E88.8193————3
Heart disease risk factorsD000082742——1————1
Lipid metabolism disordersD052439——1————1
TransgenesD019076——1————1
Alzheimer diseaseD000544EFO_0000249F031————1
DementiaD003704EFO_0003862F031————1
Peritoneal neoplasmsD010534——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypotensionD007022EFO_0005251I95————55
Thyroid neoplasmsD013964EFO_0003841—————33
Thyroid diseasesD013959—E00-E07————33
GonorrheaD006069DOID_7551A54————22
Chlamydia infectionsD002690EFO_0007205A74.9————22
Spinal anesthesiaD000775——————22
Cesarean sectionD002585——————22
Follicular adenocarcinomaD018263——————22
Septic shockD012772—A48.3————22
Female genital diseasesD005831EFO_0009549N85————11
Show 44 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
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£
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Truvada – Gilead Sciences
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Biktarvy – Gilead Sciences
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Atripla – Gilead Sciences
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Complera – Gilead Sciences
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Stribild – Gilead Sciences
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Genvoya – Gilead Sciences
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Emtriva – Gilead Sciences
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Odefsey – Gilead Sciences
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Descovy – 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 27,177 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, rilpivirine, tenofovir disoproxil fumarate, Emtricitabine/tdf, Emtriva, Genvoya, Odefsey, Stribild, Stribild access, Symtuza, Truvada, Truvada access
Adverse Events
Top Adverse Reactions
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73,710 adverse events reported
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