Emtriva(emtricitabine)
Atripla, Biktarvy, Complera, Descovy, 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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BMS
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
infections | D007239 |
urogenital diseases | D000091642 |
immune system diseases | D007154 |
Trade Name
FDA
EMA
Emtriva (generic drugs available since 2017-06-08)
CombinationsAtripla, Biktarvy, Complera, Descovy, Genvoya, Odefsey, Stribild, Symtuza, Truvada (generic drugs available since 2017-06-08)
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 |
---|---|---|---|---|
BIKTARVY | Gilead Sciences | N-210251 RX | 2018-02-07 | 2 products, RLD, RS |
Cobicistat
+
Darunavir
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
SYMTUZA | Johnson & Johnson | N-210455 RX | 2018-07-17 | 1 products, RLD, RS |
Cobicistat
+
Elvitegravir
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
GENVOYA | Gilead Sciences | N-207561 RX | 2015-11-05 | 1 products, RLD, RS |
Cobicistat
+
Elvitegravir
+
Emtricitabine
+
Tenofovir disoproxil fumarate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
STRIBILD | Gilead Sciences | N-203100 RX | 2012-08-27 | 1 products, RLD, RS |
Efavirenz
+
Emtricitabine
+
Tenofovir disoproxil fumarate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ATRIPLA | Gilead Sciences | N-021937 RX | 2006-07-12 | 1 products, RLD, RS |
Emtricitabine
Emtricitabine
+
Rilpivirine hydrochloride
+
Tenofovir alafenamide fumarate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ODEFSEY | Gilead Sciences | N-208351 RX | 2016-03-01 | 1 products, RLD, RS |
Emtricitabine
+
Rilpivirine hydrochloride
+
Tenofovir disoproxil fumarate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
COMPLERA | Gilead Sciences | N-202123 RX | 2011-08-10 | 1 products, RLD, RS |
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
DESCOVY | Gilead Sciences | N-208215 RX | 2016-04-04 | 2 products, RLD, RS |
Emtricitabine
+
Tenofovir disoproxil fumarate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
TRUVADA | Gilead Sciences | N-021752 RX | 2004-08-02 | 4 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
atripla | New Drug Application | 2021-12-14 |
biktarvy | New Drug Application | 2022-11-30 |
complera access | Export only | 2021-03-29 |
descovy | New Drug Application | 2022-01-13 |
efavirenz, emtricitabine and tenofovir disoproxil fumarate | ANDA | 2023-01-27 |
emtricitabine and tenofovir disoproxil fumarate | ANDA | 2023-06-15 |
emtriva | New Drug Application | 2021-06-29 |
genvoya | New Drug Application | 2022-01-13 |
odefsey | New Drug Application | 2021-09-17 |
stribild | New Drug Application | 2021-09-16 |
Show 2 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
hiv infections | EFO_0000764 | D015658 | B20 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
BICTEGRAVIR SODIUM / EMTRICITABINE / TENOFOVIR ALAFENAMIDE FUMARATE, BIKTARVY, GILEAD SCIENCES INC | |||
2028-10-07 | ODE-378 | ||
2026-06-18 | ODE-256 | ||
2024-02-24 | M-82 | ||
2023-02-07 | NCE | ||
EMTRICITABINE / TENOFOVIR ALAFENAMIDE FUMARATE, DESCOVY, GILEAD SCIENCES INC | |||
2024-09-28 | ODE-284, ODE-285 |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Cobicistat / Darunavir / Emtricitabine / Tenofovir Alafenamide Fumarate, Symtuza, Janssen Prods | |||
10786518 | 2038-07-19 | U-2978 | |
10039718 | 2032-10-06 | DP | |
8148374 | 2029-09-03 | DS, DP | U-1279, U-2353, U-2364, U-2365, U-2766, U-2767, U-2768 |
7700645 | 2026-12-26 | DS, DP | |
8518987 | 2024-02-16 | DS, DP | |
Bictegravir Sodium / Emtricitabine / Tenofovir Alafenamide Fumarate, Biktarvy, Gilead Sciences Inc | |||
10548846 | 2036-11-08 | DP | |
9708342 | 2035-06-19 | DS, DP | |
10385067 | 2035-06-19 | U-257 | |
9216996 | 2033-12-19 | DS, DP | |
9732092 | 2033-12-19 | DS, DP | |
8754065 | 2032-08-15 | DS, DP | U-257, U-1259, U-1663, U-2352, U-2765 |
9296769 | 2032-08-15 | DS, DP | U-257, U-1259, U-1663, U-2352, U-2765 |
7390791 | 2025-04-17 | DS, DP | |
Emtricitabine / Rilpivirine Hydrochloride / Tenofovir Disoproxil Fumarate, Complera, Gilead Sciences Inc | |||
10857102 | 2033-01-14 | DP | |
8841310 | 2025-12-09 | DP | U-257 |
Cobicistat / Elvitegravir / Emtricitabine / Tenofovir Alafenamide Fumarate, Genvoya, Gilead Sciences Inc | |||
8633219 | 2030-04-30 | DP | U-257 |
9891239 | 2029-09-03 | DP | U-257 |
7635704 | 2026-10-26 | DS, DP | U-257 |
8981103 | 2026-10-26 | DS, DP | |
7176220 | 2026-08-27 | DS, DP | U-257 |
Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate, Atripla, Gilead Sciences | |||
8598185 | 2029-04-28 | DP | |
9018192 | 2026-06-13 | U-750, U-1170 | |
9545414 | 2026-06-13 | DP | U-750, U-1170 |
Emtricitabine / Rilpivirine Hydrochloride / Tenofovir Alafenamide Fumarate, Odefsey, Gilead Sciences Inc | |||
7125879 | 2025-04-21 | DS, DP | U-257 |
8080551 | 2023-04-11 | DS, DP | |
Cobicistat / Elvitegravir / Emtricitabine / Tenofovir Disoproxil Fumarate, Stribild, Gilead Sciences Inc | |||
8592397 | 2024-01-13 | DP | U-248, U-257, U-541, U-750, U-1170 |
8716264 | 2024-01-13 | DP | U-257 |
9457036 | 2024-01-13 | DP | U-257 |
9744181 | 2024-01-13 | DP | U-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
466 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 infections | D015658 | EFO_0000764 | B20 | 20 | 62 | 79 | 75 | 32 | 255 |
Hiv | D006678 | O98.7 | 12 | 8 | 15 | 45 | 19 | 98 | |
Healthy volunteers/patients | — | 10 | — | — | 5 | 1 | 16 | ||
Hiv-1 | D015497 | — | 2 | 6 | 5 | — | 13 | ||
Infections | D007239 | EFO_0000544 | — | 2 | 5 | 3 | — | 10 | |
Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | — | 2 | 2 | 5 | 1 | 10 |
Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 1 | 6 | 2 | — | 9 |
Medication adherence | D055118 | EFO_0006344 | 1 | 1 | 2 | 3 | — | 7 | |
Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | 2 | 1 | 2 | — | 6 |
Hepatitis c | D006526 | B19.2 | 1 | 1 | — | 1 | 1 | 4 |
Show 27 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Covid-19 | D000086382 | U07.1 | — | 3 | 5 | — | 1 | 6 | |
Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 1 | 1 | 1 | — | — | 3 |
Sars-cov-2 | D000086402 | — | 1 | 2 | — | — | 2 | ||
Treatment adherence and compliance | D000074822 | — | — | 2 | — | — | 2 | ||
Breast feeding | D001942 | — | — | 1 | — | — | 1 | ||
Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | 1 | — | — | 1 |
Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | 1 | — | — | 1 |
Body weight changes | D001836 | — | — | 1 | — | — | 1 | ||
Fasting | D005215 | EFO_0002756 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Biliary liver cirrhosis | D008105 | K74.3 | — | 1 | — | — | 1 | 2 | |
Parasitemia | D018512 | 1 | 1 | — | — | — | 1 | ||
Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 1 | — | — | — | 1 |
Progressive multifocal leukoencephalopathy | D007968 | EFO_0007455 | A81.2 | — | 1 | — | — | — | 1 |
Gender identity | D005783 | 1 | 1 | — | — | — | 1 | ||
Behavior and behavior mechanisms | D001520 | 1 | 1 | — | — | — | 1 | ||
Amphetamine-related disorders | D019969 | EFO_0004701 | F15 | — | 1 | — | — | — | 1 |
Hepatitis b virus | D006515 | — | 1 | — | — | — | 1 | ||
Patient acceptance of health care | D010342 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Transgenes | D019076 | 1 | — | — | — | — | 1 | ||
Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | — | — | — | 1 |
Contraception | D003267 | 1 | — | — | — | — | 1 | ||
Insulin resistance | D007333 | EFO_0002614 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Sustained virologic response | D000072230 | — | — | — | — | 1 | 1 | ||
Drug interactions | D004347 | — | — | — | — | 1 | 1 | ||
Acute kidney injury | D058186 | HP_0001919 | N17 | — | — | — | — | 1 | 1 |
Bone diseases | D001847 | M89.9 | — | — | — | — | 1 | 1 | |
Inflammation | D007249 | — | — | — | — | 1 | 1 | ||
Pharmacokinetics | D010599 | — | — | — | — | 1 | 1 | ||
Infertility | D007246 | EFO_0000545 | — | — | — | — | 1 | 1 | |
Risk reduction behavior | D040242 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | EMTRICITABINE |
INN | emtricitabine |
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 class | nucleoside antiviral or antineoplastic agents, cytarabine or azarabine derivatives |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | Nc1nc(=O)n([C@@H]2CS[C@H](CO)O2)cc1F |
Identifiers
PDB | — |
CAS-ID | 143491-57-0 |
RxCUI | 276237 |
ChEMBL ID | CHEMBL885 |
ChEBI ID | 31536 |
PubChem CID | 60877 |
DrugBank | DB00879 |
UNII ID | G70B4ETF4S (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Biktarvy - Gilead Sciences
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Stribild - Gilead Sciences
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Atripla - Gilead Sciences
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Descovy - Gilead Sciences
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Emtriva - Gilead Sciences
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Truvada - Gilead Sciences
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Complera - Gilead Sciences
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Genvoya - Gilead Sciences
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Odefsey - Gilead Sciences
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Trends
PubMed Central
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Additional graphs summarizing 14,041 documents
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Safety
Black-box Warning
Black-box warning for: Atripla, Biktarvy, Complera access, Descovy, Efavirenz, emtricitabine and tenofovir disoproxil fumarate, Emtricitabine and tenofovir disoproxil fumarate, Emtriva, Genvoya, Odefsey, Stribild, Symtuza, Truvada
Adverse Events
Top Adverse Reactions
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1,340 adverse events reported
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