Tenofovir
Biktarvy, Cimduo, Complera, Delstrigo, Descovy, Efavirenz / / Tenofovir Disoproxil, Efavirenz / Emtricitabine / Tenofovir Disoproxil, Emtricitabine / Tenofovir Disoproxil, Genvoya, Odefsey, Stribild, Symfi, Symtuza, Tenofovir Disoproxil, Truvada, Vemlidy, Viread (tenofovir) is a small molecule pharmaceutical. Tenofovir was first approved as Viread on 2001-10-26. It is used to treat acquired immunodeficiency syndrome, chronic hepatitis b, hepatitis b, and HIV infections in the USA. It has been approved in Europe to treat hepatitis b and HIV infections.
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Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| atripla | New Drug Application | 2017-01-23 |
| biktarvy | New Drug Application | 2025-07-30 |
| cimduo | New Drug Application | 2021-02-15 |
| complera | New Drug Application | 2025-07-16 |
| complera access | Export only | 2025-07-16 |
| delstrigo | New Drug Application | 2025-06-12 |
| descovy | New Drug Application | 2025-06-20 |
| efavirenz, emtricitabine and tenofovir disoproxil fumarate | ANDA | 2025-07-28 |
| efavirenz, lamivudine and tenofovir disoproxil fumarate | ANDA | 2024-05-07 |
| emtricitabine and tenofovir disoproxil fumarate | ANDA | 2025-08-20 |
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Indications
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DORAVIRINE / LAMIVUDINE / TENOFOVIR DISOPROXIL FUMARATE, DELSTRIGO, MSD MERCK CO | |||
| 2025-01-27 | NPP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate, Delstrigo, Msd Merck Co | |||
| 10603282 | 2036-11-29 | DP | |
| 10842751 | 2036-11-29 | DP | |
| 8486975 | 2031-10-07 | DS, DP | U-2395, U-2629, U-3307 |
| Emtricitabine / Rilpivirine Hydrochloride / Tenofovir Disoproxil Fumarate, Complera, Gilead Sciences Inc | |||
| 10857102 | 2033-01-14 | DP | |
| 8841310 | 2025-12-09 | DP | U-257 |
| 7125879 | 2025-04-21 | DS, DP | U-257 |
| Cobicistat / Elvitegravir / Emtricitabine / Tenofovir Disoproxil Fumarate, Stribild, Gilead Sciences Inc | |||
| 10039718 | 2032-10-06 | DP | |
| 8633219 | 2030-04-30 | DP | U-257 |
| 8148374 | 2029-09-03 | DS, DP | U-1279 |
| 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 |
| 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 |
| 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 |
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AF: Nucleoside and nucleotide reverse transcriptase inhibitors
— J05AF07: Tenofovir disoproxil
— J05AF13: Tenofovir alafenamide
— 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
— J05AR11: Lamivudine, tenofovir disoproxil and efavirenz
— J05AR12: Lamivudine and tenofovir disoproxil
— 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
— J05AR24: Lamivudine, tenofovir disoproxil and doravirine
— J05AR27: Lamivudine, tenofovir disoproxil and dolutegravir
HCPCS
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Clinical
Clinical Trials
1365 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 | 11 | 41 | 74 | 49 | 17 | 177 |
| Hepatitis b | D006509 | — | — | 2 | 14 | 16 | 13 | 5 | 49 |
| Hiv | D006678 | — | O98.7 | 2 | 6 | 16 | 20 | 7 | 47 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 1 | 15 | 14 | 9 | 4 | 43 |
| Hepatitis | D006505 | — | K75.9 | 1 | 11 | 12 | 12 | 5 | 41 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 7 | 20 | 14 | 3 | 40 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | 8 | 9 | 8 | 4 | 30 |
| Chronic hepatitis | D006521 | — | K73.9 | 1 | 8 | 6 | 5 | 4 | 24 |
| Infections | D007239 | EFO_0000544 | — | — | 3 | 4 | 4 | 4 | 14 |
| Coinfection | D060085 | — | — | — | — | 2 | 4 | — | 6 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis b virus | D006515 | — | — | 1 | 1 | 1 | — | 1 | 4 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | 1 | 2 | — | — | 3 |
| Virus diseases | D014777 | — | B34 | — | 1 | 1 | — | — | 2 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | 1 | — | — | 1 |
| Treatment adherence and compliance | D000074822 | — | — | — | — | 1 | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | — | — | 1 | — | — | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | 1 | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | 1 | — | — | 1 |
| Breast feeding | D001942 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Chronic hepatitis d | D019701 | — | — | — | 1 | — | — | — | 1 |
| Hepatitis d | D003699 | EFO_0007304 | — | — | 1 | — | — | — | 1 |
| Herpesviridae infections | D006566 | EFO_0007309 | B00.4 | — | 1 | — | — | — | 1 |
| Patient acceptance of health care | D010342 | — | — | — | 1 | — | — | — | 1 |
| Fatigue | D005221 | — | R53.83 | — | 1 | — | — | — | 1 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 1 | — | — | — | 1 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | 1 | — | — | — | 1 |
| Leukoencephalopathies | D056784 | — | R90.82 | — | 1 | — | — | — | 1 |
| Progressive multifocal leukoencephalopathy | D007968 | EFO_0007455 | A81.2 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv seropositivity | D006679 | — | — | — | — | — | — | 3 | 3 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 1 | 1 |
| Biliary liver cirrhosis | D008105 | — | K74.3 | — | — | — | — | 1 | 1 |
| Job syndrome | D007589 | EFO_0003775 | D82.4 | — | — | — | — | 1 | 1 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | — | — | — | 1 | 1 |
| Retinal diseases | D012164 | — | H35.9 | — | — | — | — | 1 | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | — | 1 | 1 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tenofovir |
| INN | tenofovir |
| Description | Tenofovir disoproxil is an organic phosphonate that is the disoproxil ester of tenofovir. A prodrug for tenofovir, an HIV-1 reverse transcriptase inhibitor, tenofovir disoproxil is used as the fumaric acid salt in combination therapy for the treatment of HIV infection. It has a role as a prodrug, a HIV-1 reverse transcriptase inhibitor and an antiviral drug. It is functionally related to a tenofovir (anhydrous). |
| Classification | Small molecule |
| Drug class | antivirals |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O |
Identifiers
| PDB | — |
| CAS-ID | 147127-20-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL483 |
| ChEBI ID | 63625 |
| PubChem CID | 5481350 |
| DrugBank | DB00300 |
| UNII ID | W4HFE001U5 (ChemIDplus, GSRS) |
Target
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Vemlidy – Gilead Sciences
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Viread – Gilead Sciences
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Delstrigo – Merck & Co
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Stribild – Gilead Sciences
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Biktarvy – Gilead Sciences
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Odefsey – Gilead Sciences
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Complera – Gilead Sciences
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Truvada – Gilead Sciences
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Descovy – Gilead Sciences
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Genvoya – Gilead Sciences
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Atripla – Gilead Sciences
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Estimated US medical usage
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Emtricitabine
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Rilpivirine
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Tenofovir
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Trends
PubMed Central
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Additional graphs summarizing 35,398 documents
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Safety
Black-box Warning
Black-box warning for: Atripla, Biktarvy, Cimduo, Complera, Complera access, Delstrigo, Descovy, Efavirenz, emtricitabine and tenofovir disoproxil fumarate, Efavirenz, lamivudine and tenofovir disoproxil fumarate, Emtricitabine and tenofovir disoproxil fumarate, Emtricitabine, rilpivirine, tenofovir disoproxil fumarate, Genvoya, Odefsey, Stribild, Stribild access, Symfi, Symfi lo, Symtuza, Tenofovir disoproxil fumarate, Tenofovir disproxil fumarate, Truvada, Truvada access, Vemlidy, Viread, Viread access
Adverse Events
Top Adverse Reactions
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96,736 adverse events reported
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