Sustiva(efavirenz)
Atripla, Efavirenz, Efavirenz / / Tenofovir Disoproxil, Stocrin, Sustiva, Symfi (efavirenz) is a small molecule pharmaceutical. Efavirenz was first approved as Sustiva on 1998-09-17. It is used to treat acquired immunodeficiency syndrome and HIV infections in the USA. It has been approved in Europe to treat HIV infections. It is known to target cytochrome P450 3A4.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Combinations
Atripla, Symfi, Symfi lo (generic drugs available since 2017-12-15)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Efavirenz
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SUSTIVA | Bristol Myers Squibb | N-020972 DISCN | 1998-09-17 | 3 products, RLD |
| SUSTIVA | Bristol Myers Squibb | N-021360 DISCN | 2002-02-01 | 2 products, RLD |
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Efavirenz
+
Emtricitabine
+
Tenofovir disoproxil fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ATRIPLA | Gilead Sciences | N-021937 RX | 2006-07-12 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| atripla | New Drug Application | 2024-07-09 |
| atripla access | Export only | 2021-04-12 |
| efavirenz | ANDA | 2024-09-05 |
| efavirenz, emtricitabine and tenofovir disoproxil fumarate | ANDA | 2024-06-27 |
| efavirenz, lamivudine and tenofovir disoproxil fumarate | ANDA | 2024-05-07 |
| sustiva | New Drug Application | 2013-01-02 |
| symfi | New Drug Application | 2019-10-15 |
| symfi lo | New Drug Application | 2019-10-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hiv infections | EFO_0000764 | D015658 | B20 |
| acquired immunodeficiency syndrome | EFO_0000765 | D000163 | B20 |
| hiv | — | D006678 | — |
| chronic hepatitis b | EFO_0004239 | D019694 | B18.1 |
| hepatitis b | — | D006509 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| 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 |
| 8592397 | 2024-01-13 | DP | 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
— J05AG: Non-nucleoside reverse transcriptase inhibitors
— J05AG03: Efavirenz
— J05AR: Antivirals for treatment of hiv infections, combinations
— J05AR06: Emtricitabine, tenofovir disoproxil and efavirenz
— J05AR11: Lamivudine, tenofovir disoproxil and efavirenz
HCPCS
No data
Clinical
Clinical Trials
489 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 | 35 | 76 | 108 | 78 | 71 | 354 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 11 | 16 | 29 | 15 | 27 | 95 |
| Hiv | D006678 | — | — | 11 | 12 | 9 | 21 | 23 | 71 |
| Infections | D007239 | EFO_0000544 | — | 9 | 18 | 14 | 9 | 12 | 61 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 5 | 9 | 8 | 9 | 10 | 40 |
| Communicable diseases | D003141 | — | — | 6 | 5 | 6 | 5 | 6 | 27 |
| Healthy volunteers/patients | — | — | — | 17 | — | — | 4 | — | 21 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | — | 6 | 8 | 4 | 2 | 19 |
| Hepatitis c | D006526 | — | B19.2 | 5 | 3 | 3 | 3 | 6 | 19 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 5 | 2 | 3 | 5 | 5 | 19 |
Show 34 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | 1 | 2 | — | 1 | 3 |
| Breast feeding | D001942 | — | — | — | — | 1 | — | 1 | 2 |
| Pregnancy rate | D018873 | — | — | — | — | 1 | — | — | 1 |
| Chronic hepatitis | D006521 | — | K73.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | 1 | — | — | 2 | 3 |
| Arteritis | D001167 | EFO_0009011 | I77.6 | — | 2 | — | — | — | 2 |
| Lymphoma | D008223 | — | C85.9 | 1 | 1 | — | — | — | 2 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 1 | — | — | — | 1 |
| Parasitemia | D018512 | — | — | 1 | 1 | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | — | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | — | — | — | 1 |
| Aids-related lymphoma | D016483 | EFO_1001365 | — | — | 1 | — | — | — | 1 |
| Hepatitis b virus | D006515 | — | — | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
Show 2 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 4 | — | — | — | 1 | 5 |
| Neoplasms | D009369 | — | C80 | 3 | — | — | — | — | 3 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | — | — | — | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 1 | — | — | — | — | 1 |
| Toxoplasmosis | D014123 | EFO_0007517 | B58 | 1 | — | — | — | — | 1 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | — | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | — | — | — | — | 1 |
| Premature obstetric labor | D007752 | — | O60 | 1 | — | — | — | — | 1 |
Show 10 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep wake disorders | D012893 | — | G47 | — | — | — | — | 2 | 2 |
| Depression | D003863 | — | F33.9 | — | — | — | — | 2 | 2 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | — | — | — | — | 1 | 1 |
| Penicillium chrysogenum | D010408 | NCBITaxon_5076 | — | — | — | — | — | 1 | 1 |
| Biological availability | D001682 | — | — | — | — | — | — | 1 | 1 |
| Osteoporosis | D010024 | HP_0000939 | M81.0 | — | — | — | — | 1 | 1 |
| Contraception behavior | D003268 | — | — | — | — | — | — | 1 | 1 |
| Sustained virologic response | D000072230 | — | — | — | — | — | — | 1 | 1 |
| Neurobehavioral manifestations | D019954 | EFO_0004364 | — | — | — | — | — | 1 | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
Show 20 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Efavirenz |
| INN | efavirenz |
| Description | Efavirenz is 1,4-Dihydro-2H-3,1-benzoxazin-2-one substituted at the 4 position by cyclopropylethynyl and trifluoromethyl groups (S configuration) and at the 6 position by chlorine. A non-nucleoside reverse transcriptase inhibitor with activity against HIV, it is used with other antiretrovirals for combination therapy of HIV infection. It has a role as a HIV-1 reverse transcriptase inhibitor and an antiviral drug. It is a benzoxazine, an acetylenic compound, an organochlorine compound, an organofluorine compound and a member of cyclopropanes. |
| Classification | Small molecule |
| Drug class | Fc fusion protein; antivirals: non-nucleoside reverse transcriptase inhibitors; benzoxazinone derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1 |
Identifiers
| PDB | — |
| CAS-ID | 154598-52-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL223228 |
| ChEBI ID | 119486 |
| PubChem CID | 64139 |
| DrugBank | DB00625 |
| UNII ID | JE6H2O27P8 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CYP3A4
CYP3A4
Organism
Homo sapiens
Gene name
CYP3A4
Gene synonyms
CYP3A3
NCBI Gene ID
Protein name
cytochrome P450 3A4
Protein synonyms
1,4-cineole 2-exo-monooxygenase, 1,8-cineole 2-exo-monooxygenase, Albendazole monooxygenase (sulfoxide-forming), Albendazole sulfoxidase, Cholesterol 25-hydroxylase, CYPIIIA3, CYPIIIA4, Cytochrome P450 3A3, Cytochrome P450 HLp, Cytochrome P450 NF-25, cytochrome P450, family 3, subfamily A, polypeptide 4, cytochrome P450, subfamily IIIA (niphedipine oxidase), polypeptide 3, cytochrome P450, subfamily IIIA (niphedipine oxidase), polypeptide 4, Cytochrome P450-PCN1, glucocorticoid-inducible P450, Nifedipine oxidase, P450-III, steroid inducible, Quinine 3-monooxygenase, taurochenodeoxycholate 6-alpha-hydroxylase
Uniprot ID
Mouse ortholog
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Variants
No data
Financial
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Atripla – Gilead Sciences
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Estimated US medical usage
Efavirenz
Total medical expenditures per year (USD, in millions)
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Efavirenz
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Emtricitabine
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Tenofovir
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
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Additional graphs summarizing 21,221 documents
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Safety
Black-box Warning
Black-box warning for: Atripla, Atripla access, Efavirenz, emtricitabine and tenofovir disoproxil fumarate, Efavirenz, lamivudine and tenofovir disoproxil fumarate, Symfi, Symfi lo
Adverse Events
Top Adverse Reactions
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33,228 adverse events reported
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