Viread(tenofovir disoproxil)
Cimduo, Complera, Delstrigo, Efavirenz / / Tenofovir Disoproxil, Efavirenz / Emtricitabine / Tenofovir Disoproxil, Emtricitabine / Tenofovir Disoproxil, Eviplera, Stribild, Symfi, Tenofovir Disoproxil, Truvada, Viread (tenofovir disoproxil) is a small molecule pharmaceutical. Tenofovir disoproxil was first approved as Viread on 2001-10-26. It is used to treat chronic hepatitis b and HIV in the USA. It has been approved in Europe to treat chronic hepatitis b and HIV infections.
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Commercial
Trade Name
FDA
EMA
Tenofovir disoproxil, Viread (discontinued: Tenofovir disoproxil)
CombinationsCimduo, Complera, Delstrigo, Efavirenz, emtricitabine, tenofovir disoproxil, Efavirenz, lamivudine tenofovir disoproxil, Emtricitabine tenofovir disoproxil, Emtricitabine, rilpivirine tenofovir disoproxil, Stribild, Symfi, Symfi lo, Truvada (discontinued: Atripla, Efavirenz, lamivudine tenofovir disoproxil, Efavirenz; emtricitabine tenofovir disoproxil, Efavirenz; emtricitabine; tenofovir disoproxil, Emtricitabine tenofovir disoproxil, Lamivudine tenofovir disoproxil, Temixys)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lamivudine
+
Tenofovir disoproxil fumarate
Efavirenz
+
Lamivudine
+
Tenofovir disoproxil fumarate
Doravirine
+
Lamivudine
+
Tenofovir disoproxil fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DELSTRIGO | Merck & Co | N-210807 RX | 2018-08-30 | 1 products, RLD, RS |
Efavirenz
+
Emtricitabine
+
Tenofovir disoproxil fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ATRIPLA | Gilead Sciences | N-021937 DISCN | 2006-07-12 | 1 products, RLD |
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Emtricitabine
+
Rilpivirine hydrochloride
+
Tenofovir disoproxil fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| COMPLERA | Gilead Sciences | N-202123 RX | 2011-08-10 | 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 |
Emtricitabine
+
Tenofovir disoproxil fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TRUVADA | Gilead Sciences | N-021752 RX | 2004-08-02 | 4 products, RLD, RS |
Tenofovir disoproxil fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VIREAD | Gilead Sciences | N-021356 RX | 2001-10-26 | 4 products, RLD, RS |
| VIREAD | Gilead Sciences | N-022577 RX | 2012-01-18 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| atripla | New Drug Application | 2017-01-23 |
| atripla access | Export only | 2021-04-12 |
| cimduo | New Drug Application | 2021-02-15 |
| complera | New Drug Application | 2024-09-24 |
| complera access | Export only | 2024-09-23 |
| delstrigo | New Drug Application | 2025-01-28 |
| efavirenz, emtricitabine and tenofovir disoproxil fumarate | ANDA | 2024-06-27 |
| efavirenz, lamivudine and tenofovir disoproxil fumarate | ANDA | 2024-05-07 |
| emtricitabine and tenofovir disoproxil fumarate | ANDA | 2025-06-03 |
| emtricitabine, rilpivirine, tenofovir disoproxil fumarate | ANDA | 2024-12-14 |
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Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DORAVIRINE / LAMIVUDINE / TENOFOVIR DISOPROXIL FUMARATE, DELSTRIGO, MSD MERCK CO | |||
| 2025-01-27 | NPP | ||
| 2023-08-30 | NCE | ||
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 |
| 8080551 | 2023-04-11 | DS, DP | |
| 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
— 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
— J05AR24: Lamivudine, tenofovir disoproxil and doravirine
— J05AR27: Lamivudine, tenofovir disoproxil and dolutegravir
HCPCS
No data
Clinical
Clinical Trials
1338 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 | 2 | 13 | 20 | 12 | 10 | 57 |
| Hiv | D006678 | — | O98.7 | — | 2 | 3 | 10 | 3 | 18 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 3 | 7 | 3 | 3 | 17 |
| Infections | D007239 | EFO_0000544 | — | 1 | — | 6 | 2 | 5 | 14 |
| Communicable diseases | D003141 | — | — | — | — | 4 | 1 | 4 | 9 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | 3 | 2 | 1 | — | 6 |
| Hepatitis b | D006509 | — | — | — | — | — | 2 | 1 | 3 |
| Hepatitis | D006505 | — | K75.9 | — | — | — | 2 | 1 | 3 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | — | — | — | 2 | 1 | 3 |
| Body weight | D001835 | EFO_0004338 | — | — | — | 1 | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 1 | 1 | — | 1 | 3 |
| Hiv-1 | D015497 | — | — | — | 1 | 2 | — | — | 3 |
| Hiv-2 | D015498 | — | — | — | — | 1 | — | — | 1 |
| Breast feeding | D001942 | — | — | — | — | 1 | — | — | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | 1 | — | — | 1 |
| Antibiotic prophylaxis | D019072 | — | — | — | — | 1 | — | — | 1 |
| Virus diseases | D014777 | — | B34 | — | — | 1 | — | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | 1 | — | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | 1 | — | — | 1 |
| Body weight changes | D001836 | — | — | — | — | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | — | N19 | — | 1 | — | — | — | 1 |
| Viremia | D014766 | — | B34.9 | — | 1 | — | — | — | 1 |
| Biliary liver cirrhosis | D008105 | — | K74.3 | — | 1 | — | — | — | 1 |
| Cholangitis | D002761 | HP_0030151 | K83.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart disease risk factors | D000082742 | — | — | 1 | — | — | — | — | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | — | — | — | — | 1 |
| Lipid metabolism disorders | D052439 | — | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neurotoxicity syndromes | D020258 | — | G92 | — | — | — | — | 1 | 1 |
| Neurocognitive disorders | D019965 | — | F09 | — | — | — | — | 1 | 1 |
| Hepatitis c | D006526 | — | B19.2 | — | — | — | — | 1 | 1 |
| Coinfection | D060085 | — | — | — | — | — | — | 1 | 1 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 1 | 1 |
| Proteinuria | D011507 | — | R80 | — | — | — | — | 1 | 1 |
| Hiv seropositivity | D006679 | — | — | — | — | — | — | 1 | 1 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tenofovir disoproxil |
| INN | — |
| Description | Tenofovir (anhydrous) is a member of the class of phosphonic acids that is methylphosphonic acid in which one of the methyl hydrogens is replaced by a [(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy group. An inhibitor of HIV-1 reverse transcriptase, the bis(isopropyloxycarbonyloxymethyl) ester (disoproxil ester) prodrug is used as the fumaric acid salt in combination therapy for the treatment of HIV infection. It has a role as a HIV-1 reverse transcriptase inhibitor, an antiviral drug and a drug metabolite. It is a member of phosphonic acids and a nucleoside analogue. It is a conjugate acid of a tenofovir(1-). |
| Classification | Small molecule |
| Drug class | antivirals |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)OC(=O)OCOP(=O)(CO[C@H](C)Cn1cnc2c(N)ncnc21)OCOC(=O)OC(C)C |
Identifiers
| PDB | — |
| CAS-ID | 147127-20-6 |
| RxCUI | 117466 |
| ChEMBL ID | CHEMBL1538 |
| ChEBI ID | 63717 |
| PubChem CID | 464205 |
| DrugBank | DB00300 |
| UNII ID | — |
Target
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Variants
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Financial
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Stribild – Gilead Sciences
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Complera – Gilead Sciences
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Delstrigo – Merck & Co
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Atripla – Gilead Sciences
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Truvada – Gilead Sciences
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Viread – Gilead Sciences
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 14,569 documents
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Safety
Black-box Warning
Black-box warning for: Atripla, Atripla access, Cimduo, Complera, Complera access, Delstrigo, Efavirenz, emtricitabine and tenofovir disoproxil fumarate, Efavirenz, lamivudine and tenofovir disoproxil fumarate, Emtricitabine and tenofovir disoproxil fumarate, Emtricitabine, rilpivirine, tenofovir disoproxil fumarate, Stribild, Stribild access, Symfi, Symfi lo, Tenofovir disoproxil fumarate, Tenofovir disproxil fumarate, Truvada, Truvada access, Viread, Viread access
Adverse Events
Top Adverse Reactions
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86,833 adverse events reported
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