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tenofovir alafenamide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antivirals phosphonic acid derivatives | 4944 | 379270-37-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
a phosphonoamidate prodrug of tenofovir (2'deoxyadenosine monophosphate analog). Plasma exposure to tenofovir alafenamide allows for permeation into cells and then tenofovir alafenamide is intracellularly converted to tenofovir through hydrolysis by cathepsin A. Tenofovir is subsequently phosphorylated by cellular kinases to the active metabolite tenofovir diphosphate. Tenofovir diphosphate inhibits HIV replication through incorporation into viral DNA by the HIV reverse transcriptase, which results in DNA chain-termination
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 25 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 2 mg/mL | Bocci G, Oprea TI, Benet LZ |
| S (Water solubility) | 4.70 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
| BA (Bioavailability) | 25 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AXL,CAMK2D,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,MAP3K21,MAPK7,PDK1,PDK2,PIK3CD,PRKDC | 15 | |||
| kinase-selectivity-class | AXL,GRK2 | 2 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 5, 2015 | FDA | GILEAD SCIENCES INC | |
| Feb. 20, 2014 | EMA | ||
| Dec. 19, 2016 | PMDA | Gilead Sciences |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Maternal exposure during pregnancy | 62.99 | 28.44 | 49 | 1379 | 360014 | 90267005 |
| Viral load increased | 50.17 | 28.44 | 10 | 1418 | 1546 | 90625473 |
| Hepatitis B DNA increased | 44.36 | 28.44 | 7 | 1421 | 283 | 90626736 |
| Drug resistance | 40.68 | 28.44 | 16 | 1412 | 30433 | 90596586 |
| Hepatocellular carcinoma | 40.21 | 28.44 | 9 | 1419 | 2419 | 90624600 |
| Hepatitis B | 39.55 | 28.44 | 10 | 1418 | 4509 | 90622510 |
| Chemotherapy | 31.50 | 28.44 | 7 | 1421 | 1820 | 90625199 |
| Hepatitis B DNA assay positive | 30.74 | 28.44 | 4 | 1424 | 39 | 90626980 |
| Virologic failure | 30.13 | 28.44 | 7 | 1421 | 2217 | 90624802 |
| Liver transplant | 29.85 | 28.44 | 7 | 1421 | 2310 | 90624709 |
| Death | 29.46 | 28.44 | 36 | 1392 | 456515 | 90170504 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hepatitis B DNA increased | 98.97 | 25.85 | 19 | 2761 | 570 | 42617985 |
| Immune reconstitution inflammatory syndrome | 92.96 | 25.85 | 32 | 2748 | 10111 | 42608444 |
| Hepatocellular carcinoma | 71.78 | 25.85 | 25 | 2755 | 8169 | 42610386 |
| Death | 67.44 | 25.85 | 114 | 2666 | 471071 | 42147484 |
| Fanconi syndrome acquired | 55.83 | 25.85 | 15 | 2765 | 2055 | 42616500 |
| Viral load increased | 54.72 | 25.85 | 16 | 2764 | 2981 | 42615574 |
| Hepatitis B DNA assay positive | 50.40 | 25.85 | 8 | 2772 | 75 | 42618480 |
| Hepatitis B | 45.70 | 25.85 | 17 | 2763 | 6694 | 42611861 |
| Product storage error | 43.80 | 25.85 | 19 | 2761 | 11121 | 42607434 |
| Pathogen resistance | 43.30 | 25.85 | 19 | 2761 | 11431 | 42607124 |
| Virologic failure | 42.07 | 25.85 | 14 | 2766 | 3980 | 42614575 |
| Hepatic cancer | 41.83 | 25.85 | 17 | 2763 | 8463 | 42610092 |
| Treatment noncompliance | 40.28 | 25.85 | 27 | 2753 | 37645 | 42580910 |
| Retroperitoneal disorder | 39.11 | 25.85 | 6 | 2774 | 44 | 42618511 |
| Liver transplant | 38.90 | 25.85 | 12 | 2768 | 2679 | 42615876 |
| Drug resistance | 37.71 | 25.85 | 25 | 2755 | 34223 | 42584332 |
| Renal aneurysm | 36.68 | 25.85 | 7 | 2773 | 203 | 42618352 |
| HIV associated nephropathy | 33.03 | 25.85 | 7 | 2773 | 347 | 42618208 |
| Pulmonary venous thrombosis | 31.96 | 25.85 | 6 | 2774 | 159 | 42618396 |
| Portal venous gas | 30.50 | 25.85 | 7 | 2773 | 502 | 42618053 |
| Lung transplant rejection | 30.19 | 25.85 | 8 | 2772 | 1039 | 42617516 |
| Dysphagia | 28.36 | 25.85 | 29 | 2751 | 72690 | 42545865 |
| Mesenteric artery thrombosis | 27.95 | 25.85 | 7 | 2773 | 727 | 42617828 |
| Osteoporosis | 27.05 | 25.85 | 15 | 2765 | 14891 | 42603664 |
| Product dispensing error | 26.70 | 25.85 | 12 | 2768 | 7627 | 42610928 |
| Renal tubular dysfunction | 25.90 | 25.85 | 6 | 2774 | 448 | 42618107 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hepatitis B DNA increased | 117.13 | 24.18 | 21 | 3774 | 834 | 110584670 |
| Hepatocellular carcinoma | 113.99 | 24.18 | 32 | 3763 | 9848 | 110575656 |
| Death | 106.72 | 24.18 | 125 | 3670 | 698744 | 109886760 |
| Hepatitis B | 75.02 | 24.18 | 23 | 3772 | 9589 | 110575915 |
| Drug resistance | 62.67 | 24.18 | 33 | 3762 | 56341 | 110529163 |
| Fanconi syndrome acquired | 59.69 | 24.18 | 15 | 3780 | 3019 | 110582485 |
| Liver transplant | 53.53 | 24.18 | 15 | 3780 | 4574 | 110580930 |
| Hepatitis B DNA assay positive | 53.36 | 24.18 | 8 | 3787 | 101 | 110585403 |
| Virologic failure | 52.41 | 24.18 | 15 | 3780 | 4937 | 110580567 |
| Hepatic cancer | 51.73 | 24.18 | 18 | 3777 | 11138 | 110574366 |
| Drug interaction | 51.73 | 24.18 | 74 | 3721 | 500109 | 110085395 |
| Treatment noncompliance | 47.10 | 24.18 | 30 | 3765 | 72960 | 110512544 |
| Dysphagia | 46.50 | 24.18 | 40 | 3755 | 153560 | 110431944 |
| Hepatitis B reactivation | 46.30 | 24.18 | 15 | 3780 | 7469 | 110578035 |
| Immune reconstitution inflammatory syndrome | 45.16 | 24.18 | 18 | 3777 | 16208 | 110569296 |
| Chemotherapy | 44.16 | 24.18 | 11 | 3784 | 2135 | 110583369 |
| Pathogen resistance | 43.68 | 24.18 | 18 | 3777 | 17654 | 110567850 |
| Retroperitoneal disorder | 42.96 | 24.18 | 6 | 3789 | 44 | 110585460 |
| Viral mutation identified | 40.62 | 24.18 | 12 | 3783 | 4407 | 110581097 |
| Renal aneurysm | 38.62 | 24.18 | 7 | 3788 | 295 | 110585209 |
| Product dispensing error | 38.21 | 24.18 | 16 | 3779 | 16329 | 110569175 |
| HIV associated nephropathy | 37.36 | 24.18 | 7 | 3788 | 355 | 110585149 |
| Hepatic function abnormal | 34.89 | 24.18 | 27 | 3768 | 89268 | 110496236 |
| Portal venous gas | 34.67 | 24.18 | 7 | 3788 | 525 | 110584979 |
| Pulmonary venous thrombosis | 33.13 | 24.18 | 6 | 3789 | 252 | 110585252 |
| Off label use | 31.95 | 24.18 | 118 | 3677 | 1500067 | 109085437 |
| Renal impairment | 30.68 | 24.18 | 35 | 3760 | 188410 | 110397094 |
| Mesenteric artery thrombosis | 30.60 | 24.18 | 7 | 3788 | 946 | 110584558 |
| Lung transplant rejection | 30.42 | 24.18 | 8 | 3787 | 1923 | 110583581 |
| Viral load increased | 30.26 | 24.18 | 9 | 3786 | 3381 | 110582123 |
| Portal vein thrombosis | 27.46 | 24.18 | 10 | 3785 | 7048 | 110578456 |
| Immune reconstitution inflammatory syndrome associated tuberculosis | 24.71 | 24.18 | 6 | 3789 | 1048 | 110584456 |
| Abdominal sepsis | 24.32 | 24.18 | 7 | 3788 | 2348 | 110583156 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J05AF13 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Nucleoside and nucleotide reverse transcriptase inhibitors |
| ATC | J05AR17 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations |
| ATC | J05AR18 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations |
| ATC | J05AR19 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations |
| ATC | J05AR20 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations |
| ATC | J05AR22 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations |
| ATC | J05AR29 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000998 | Antiviral Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D018894 | Reverse Transcriptase Inhibitors |
| MeSH PA | D019380 | Anti-HIV Agents |
| MeSH PA | D019384 | Nucleic Acid Synthesis Inhibitors |
| CHEBI has role | CHEBI:36044 | antiviral drug |
| CHEBI has role | CHEBI:50266 | prodrug |
| CHEBI has role | CHEBI:53756 | HIV-1 reverse transcriptase inhibitor |
| CHEBI has role | CHEBI:64946 | anti-HIV agent |
| CHEBI has role | CHEBI:64951 | anti-HBV agent |
Related Drugs by ATC class:
J05AF Nucleoside and nucleotide reverse transcriptase inhibitors 12 drugs
J05AR Antivirals for treatment of HIV infections, combinations 19 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Human immunodeficiency virus infection | indication | 86406008 | DOID:526 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.86 | Basic |
| pKa2 | 3.96 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 150MG;150MG;200MG;EQ 10MG BASE | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 7176220 | Aug. 27, 2026 | TREATMENT OF HIV INFECTION |
| 150MG;150MG;200MG;EQ 10MG BASE | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 7635704 | Oct. 26, 2026 | TREATMENT OF HIV INFECTION |
| 150MG;150MG;200MG;EQ 10MG BASE | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE |
| 150MG;150MG;200MG;EQ 10MG BASE | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 9891239 | Sept. 3, 2029 | TREATMENT OF HIV INFECTION |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ARV REGIMEN FOR AT LEAST 6 MONTHS |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG WHO HAVE NO PRIOR ARV TREATMENT HISTORY |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TX OF HIV1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS & PEDIATRIC PATIENTS AT LEAST 40KG HAVING NO PRIOR ARV TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ARV REGIMEN FOR AT LEAST 6 MO |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TX OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENATES IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
| 150MG;150MG;200MG;EQ 10MG BASE | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 8633219 | April 30, 2030 | TREATMENT OF HIV INFECTION |
| 150MG;150MG;200MG;EQ 10MG BASE | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| 150MG;150MG;200MG;EQ 10MG BASE | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| 120MG;EQ 15MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | Jan. 7, 2022 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION |
| 120MG;EQ 15MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | Jan. 7, 2022 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION |
| 200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | PROPHYLAXIS OF HIV-1 INFECTION |
| 200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION |
| 200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| 200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | PROPHYLAXIS OF HIV-1 INFECTION |
| 200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION |
| 200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| 200MG;EQ 25MG BASE;EQ 25MG BASE | ODEFSEY | GILEAD SCIENCES INC | N208351 | March 1, 2016 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| 200MG;EQ 25MG BASE;EQ 25MG BASE | ODEFSEY | GILEAD SCIENCES INC | N208351 | March 1, 2016 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| EQ 25MG BASE | VEMLIDY | GILEAD SCIENCES INC | N208464 | Nov. 10, 2016 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS |
| EQ 25MG BASE | VEMLIDY | GILEAD SCIENCES INC | N208464 | Nov. 10, 2016 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF CHRONIC HEPATITIS B IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| EQ 25MG BASE | VEMLIDY | GILEAD SCIENCES INC | N208464 | Nov. 10, 2016 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF CHRONIC HEPATITIS B VIRUS INFECTION IN ADULTS AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 25 KG |
| EQ 25MG BASE | VEMLIDY | GILEAD SCIENCES INC | N208464 | Nov. 10, 2016 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS |
| EQ 25MG BASE | VEMLIDY | GILEAD SCIENCES INC | N208464 | Nov. 10, 2016 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF CHRONIC HEPATITIS B IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| EQ 25MG BASE | VEMLIDY | GILEAD SCIENCES INC | N208464 | Nov. 10, 2016 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF CHRONIC HEPATITIS B VIRUS INFECTION IN ADULTS AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 25 KG |
| EQ 30MG BASE;120MG;EQ 15MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Oct. 7, 2021 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| EQ 30MG BASE;120MG;EQ 15MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Oct. 7, 2021 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| EQ 50MG BASE;200MG;EQ 25MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Feb. 7, 2018 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| EQ 50MG BASE;200MG;EQ 25MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Feb. 7, 2018 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
| EQ 30MG BASE;120MG;EQ 15MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Oct. 7, 2021 | RX | TABLET | ORAL | 10385067 | June 19, 2035 | TREATMENT OF HIV INFECTION |
| EQ 50MG BASE;200MG;EQ 25MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Feb. 7, 2018 | RX | TABLET | ORAL | 10385067 | June 19, 2035 | TREATMENT OF HIV INFECTION |
| 200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | 12648911 | June 29, 2036 | PROPHYLAXIS OF HIV-1 INFECTION |
| 200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | 12648911 | June 29, 2036 | TREATMENT OF HIV-1 INFECTION |
| EQ 30MG BASE;120MG;EQ 15MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Oct. 7, 2021 | RX | TABLET | ORAL | 12594244 | Nov. 8, 2036 | TREATMENT OF HIV INFECTION |
| EQ 50MG BASE;200MG;EQ 25MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Feb. 7, 2018 | RX | TABLET | ORAL | 12594244 | Nov. 8, 2036 | TREATMENT OF HIV INFECTION |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 10786518 | July 19, 2038 | TREATMENT OF HIV-1 INFECTION IN ADULT OR PEDIATRIC PATIENTS (>=40 KG) WITH <50 COPIES/ML HIV-1 RNA AFTER >= 6 MONTHS ON PRIOR ANTIRETROVIRAL REGIMEN AND NO KNOWN DARUNAVIR OR TENOFOVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 50MG BASE;200MG;EQ 25MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Feb. 7, 2018 | RX | TABLET | ORAL | June 18, 2026 | FOR HIV-1 INFECTION IN PEDIATRIC PTS AT LEAST 25 KG W/ NO ANTIRETROVIRAL (ARV) TX HX OR TO REPLACE CURRENT ARV REGIMEN FOR VIROLOGICALLY-SUPPRESSED ON STABLE ARV W/ NO HX TX FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED W/ RESISTANCE TO BIC, FTC, OR TAF |
| EQ 30MG BASE;120MG;EQ 15MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Oct. 7, 2021 | RX | TABLET | ORAL | Feb. 23, 2027 | EXPANSION OF INDICATION TO USE OF BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE FOR THE TREATMENT OF HIV-1 INFECTION IN VIROLOGICALLY SUPPRESSED ADULTS AND PEDIATRIC PATIENTS ON A STABLE HIV-1 TREATMENT REGIMEN WITH NO KNOWN RESISTANCE TO BICTEGRAVIR OR TENOFOVIR |
| EQ 50MG BASE;200MG;EQ 25MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Feb. 7, 2018 | RX | TABLET | ORAL | Feb. 23, 2027 | EXPANSION OF INDICATION TO USE OF BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE FOR THE TREATMENT OF HIV-1 INFECTION IN VIROLOGICALLY SUPPRESSED ADULTS AND PEDIATRIC PATIENTS ON A STABLE HIV-1 TREATMENT REGIMEN WITH NO KNOWN RESISTANCE TO BICTEGRAVIR OR TENOFOVIR |
| EQ 25MG BASE | VEMLIDY | GILEAD SCIENCES INC | N208464 | Nov. 10, 2016 | RX | TABLET | ORAL | March 27, 2027 | NEW PATIENT POPULATION |
| EQ 50MG BASE;200MG;EQ 25MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Feb. 7, 2018 | RX | TABLET | ORAL | April 24, 2027 | REVISIONS TO THE LABELING TO INCLUDE INFORMATION FOR PREGNANT INDIVIDUALS |
| 120MG;EQ 15MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | Jan. 7, 2022 | RX | TABLET | ORAL | June 20, 2028 | LABELING CHANGES TO INCLUDE THE RESULTS OF STUDY GS-US-216-0128 IN CERTAIN PEDIATRIC PATIENTS |
| 200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | June 20, 2028 | LABELING CHANGES TO INCLUDE THE RESULTS OF STUDY GS-US-216-0128 IN CERTAIN PEDIATRIC PATIENTS |
| EQ 30MG BASE;120MG;EQ 15MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Oct. 7, 2021 | RX | TABLET | ORAL | Oct. 7, 2028 | A COMPLETE REGIMEN FOR THE TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTS WEIGHING 14 KG TO LESS THAN 25 KG WHO HAVE NO ANTIRETROVIRAL TREATMENT HISTORY OR TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY-SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO HISTORY OF TREATMENT FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO THE INDIVIDUAL COMPONENTS OF BIKTARVY |
| 120MG;EQ 15MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | Jan. 7, 2022 | RX | TABLET | ORAL | Jan. 7, 2029 | TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 14 KG TO LESS THAN 25 KG |
| EQ 30MG BASE;120MG;EQ 15MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Oct. 7, 2021 | RX | TABLET | ORAL | Feb. 23, 2031 | TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 14 KG TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO KNOWN OR SUSPECTED SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO BICTEGRAVIR OR TENOFOVIR AND WITH KNOWN OR SUSPECTED SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO EMTRICITABINE |
| EQ 50MG BASE;200MG;EQ 25MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Feb. 7, 2018 | RX | TABLET | ORAL | Feb. 23, 2031 | TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 14 KG TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO KNOWN OR SUSPECTED SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO BICTEGRAVIR OR TENOFOVIR AND WITH KNOWN OR SUSPECTED SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO EMTRICITABINE |
| EQ 30MG BASE;120MG;EQ 15MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Oct. 7, 2021 | RX | TABLET | ORAL | July 30, 2032 | TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTSWEIGHING AT LEAST 14 KG WITH AN ANTIRETROVIRAL TREATMENT HISTORY AND NOT VIROLOGICALLY SUPPRESSED, WITH NO KNOWN OR SUSPECTED SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO THE INTEGRASE STRAND INHIBITOR CLASS, EMTRICITABINE, OR TENOFOVIR |
| EQ 50MG BASE;200MG;EQ 25MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Feb. 7, 2018 | RX | TABLET | ORAL | July 30, 2032 | TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTSWEIGHING AT LEAST 14 KG WITH AN ANTIRETROVIRAL TREATMENT HISTORY AND NOT VIROLOGICALLY SUPPRESSED, WITH NO KNOWN OR SUSPECTED SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO THE INTEGRASE STRAND INHIBITOR CLASS, EMTRICITABINE, OR TENOFOVIR |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| EL9943AG5J | UNII |
| D10428 | KEGG_DRUG |
| 1392275-56-7 | SECONDARY_CAS_RN |
| 4021279 | VANDF |
| 4035188 | VANDF |
| C3713958 | UMLSCUI |
| CHEBI:90926 | CHEBI |
| TFO | PDB_CHEM_ID |
| CHEMBL2107825 | ChEMBL_ID |
| 9574768 | PUBCHEM_CID |
| DB09299 | DRUGBANK_ID |
| CHEMBL2364637 | ChEMBL_ID |
| 9980 | INN_ID |
| C442442 | MESH_SUPPLEMENTAL_RECORD_UI |
| 14054 | IUPHAR_LIGAND_ID |
| DB14126 | DRUGBANK_ID |
| 117466 | RXNORM |
| 31269 | MMSL |
| 31575 | MMSL |
| d04774 | MMSL |
| 009357 | NDDF |
| 016564 | NDDF |
| 395264002 | SNOMEDCT_US |
| 422091007 | SNOMEDCT_US |
| 715220007 | SNOMEDCT_US |
| 734973002 | SNOMEDCT_US |
| C0384228 | UMLSCUI |
| 206184-49-8 | SECONDARY_CAS_RN |
| 464205 | PUBCHEM_CID |
| D000068698 | MESH_DESCRIPTOR_UI |
| CHEBI:63716 | CHEBI |
| EL9943AG5J | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ODEFSEY | HUMAN PRESCRIPTION DRUG LABEL | 3 | 50090-2340 | TABLET | 25 mg | ORAL | NDA | 30 sections |
| Biktarvy | HUMAN PRESCRIPTION DRUG LABEL | 3 | 50090-6247 | TABLET | 25 mg | ORAL | NDA | 34 sections |
| Symtuza | HUMAN PRESCRIPTION DRUG LABEL | 4 | 59676-800 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 34 sections |
| Genvoya | HUMAN PRESCRIPTION DRUG LABEL | 4 | 61958-1901 | TABLET | 10 mg | ORAL | NDA | 32 sections |
| DESCOVY | HUMAN PRESCRIPTION DRUG LABEL | 2 | 61958-2002 | TABLET | 25 mg | ORAL | NDA | 35 sections |
| DESCOVY | HUMAN PRESCRIPTION DRUG LABEL | 2 | 61958-2005 | TABLET | 15 mg | ORAL | NDA | 35 sections |
| ODEFSEY | HUMAN PRESCRIPTION DRUG LABEL | 3 | 61958-2101 | TABLET | 25 mg | ORAL | NDA | 35 sections |
| VEMLIDY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61958-2301 | TABLET | 25 mg | ORAL | NDA | 35 sections |
| Biktarvy | HUMAN PRESCRIPTION DRUG LABEL | 3 | 61958-2501 | TABLET | 25 mg | ORAL | NDA | 35 sections |
| Biktarvy | HUMAN PRESCRIPTION DRUG LABEL | 3 | 61958-2505 | TABLET | 15 mg | ORAL | NDA | 35 sections |
| Biktarvy | HUMAN PRESCRIPTION DRUG LABEL | 3 | 61958-2506 | TABLET | 15 mg | ORAL | NDA | 35 sections |