Stem definition | Drug id | CAS RN |
---|---|---|
antivirals phosphonic acid derivatives | 4944 | 379270-37-8 |
Dose | Unit | Route |
---|---|---|
25 | mg | O |
None
Date | Agency | Company | Orphan |
---|---|---|---|
Nov. 5, 2015 | FDA | GILEAD SCIENCES INC | |
Feb. 20, 2014 | EMA | ||
Dec. 19, 2016 | PMDA | Gilead Sciences |
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 | 53.86 | 33.86 | 32 | 682 | 189521 | 56101832 |
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 |
---|---|---|---|---|---|---|
Immune reconstitution inflammatory syndrome | 83.09 | 30.59 | 25 | 1289 | 8153 | 31687877 |
Hepatitis B | 55.80 | 30.59 | 17 | 1297 | 5764 | 31690266 |
Hepatitis B DNA increased | 45.14 | 30.59 | 9 | 1305 | 524 | 31695506 |
Hepatocellular carcinoma | 41.27 | 30.59 | 15 | 1299 | 8741 | 31687289 |
Product storage error | 40.50 | 30.59 | 14 | 1300 | 7052 | 31688978 |
Fanconi syndrome acquired | 38.66 | 30.59 | 10 | 1304 | 1870 | 31694160 |
Pulmonary venous thrombosis | 36.95 | 30.59 | 6 | 1308 | 107 | 31695923 |
Lung transplant rejection | 36.36 | 30.59 | 8 | 1306 | 751 | 31695279 |
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 | 79.48 | 26.24 | 14 | 1756 | 696 | 70925978 |
Hepatitis B | 67.59 | 26.24 | 19 | 1751 | 8095 | 70918579 |
Hepatocellular carcinoma | 46.45 | 26.24 | 15 | 1755 | 10193 | 70916481 |
Off label use | 40.94 | 26.24 | 69 | 1701 | 742991 | 70183683 |
Fanconi syndrome acquired | 40.75 | 26.24 | 10 | 1760 | 2517 | 70924157 |
Pulmonary venous thrombosis | 39.43 | 26.24 | 6 | 1764 | 118 | 70926556 |
Lung transplant rejection | 35.64 | 26.24 | 8 | 1762 | 1372 | 70925302 |
Drug resistance | 33.01 | 26.24 | 17 | 1753 | 38173 | 70888501 |
Dysphagia | 30.37 | 26.24 | 24 | 1746 | 112810 | 70813864 |
Drug interaction | 28.68 | 26.24 | 41 | 1729 | 381400 | 70545274 |
Viral mutation identified | 27.97 | 26.24 | 8 | 1762 | 3614 | 70923060 |
HIV associated nephropathy | 27.09 | 26.24 | 5 | 1765 | 323 | 70926351 |
Cytomegalovirus colitis | 26.75 | 26.24 | 8 | 1762 | 4218 | 70922456 |
Liver transplant | 26.68 | 26.24 | 8 | 1762 | 4258 | 70922416 |
None
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 |
MeSH PA | D019380 | Anti-HIV Agents |
MeSH PA | D000890 | Anti-Infective Agents |
MeSH PA | D044966 | Anti-Retroviral Agents |
MeSH PA | D000998 | Antiviral Agents |
MeSH PA | D004791 | Enzyme Inhibitors |
MeSH PA | D019384 | Nucleic Acid Synthesis Inhibitors |
MeSH PA | D018894 | Reverse Transcriptase Inhibitors |
CHEBI has role | CHEBI:36044 | antiviral drugs |
CHEBI has role | CHEBI:53756 | reverse transcriptase inhibitors |
CHEBI has role | CHEBI:50266 | Prodrugs |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Human immunodeficiency virus infection | indication | 86406008 | DOID:526 |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 4.86 | Basic |
pKa2 | 3.96 | Basic |
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 | 7803788 | Feb. 2, 2022 | TREATMENT OF HIV INFECTION |
200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | 7803788 | Feb. 2, 2022 | TREATMENT OF HIV-1 INFECTION |
200MG;EQ 25MG BASE;EQ 25MG BASE | ODEFSEY | GILEAD SCIENCES INC | N208351 | March 1, 2016 | RX | TABLET | ORAL | 7803788 | Feb. 2, 2022 | TREATMENT OF HIV INFECTION |
EQ 25MG BASE | VEMLIDY | GILEAD SCIENCES INC | N208464 | Nov. 10, 2016 | RX | TABLET | ORAL | 7803788 | Feb. 2, 2022 | TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS |
EQ 30MG BASE;120MG;EQ 15MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Oct. 7, 2021 | RX | TABLET | ORAL | 7803788 | Feb. 2, 2022 | TREATMENT OF HIV INFECTION |
EQ 50MG BASE;200MG;EQ 25MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Feb. 7, 2018 | RX | TABLET | ORAL | 7803788 | Feb. 2, 2022 | TREATMENT OF HIV INFECTION |
150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 7803788 | Feb. 2, 2022 | 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 | 7803788 | Feb. 2, 2022 | 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 |
200MG;EQ 25MG BASE;EQ 25MG BASE | ODEFSEY | GILEAD SCIENCES INC | N208351 | March 1, 2016 | RX | TABLET | ORAL | 7125879 | April 21, 2025 | TREATMENT OF HIV INFECTION |
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 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 PHARMACOKINETIC ENHANCER THAT INIBITS 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 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 | 9296769 | Aug. 15, 2032 | TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS |
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 |
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 |
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, 2022 | NEW PATIENT POPULATION |
200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | Oct. 3, 2022 | FOR USE IN AT RISK ADULTS AND ADOLESCENTS WEIGHING AT LEAST 35 KG FOR PRE-EXPOSURE PROPHYLAXIS TO REDUCE THE RISK OF HIV-1 INFECTION FROM SEXUAL ACQUISITION, EXCLUDING INDIVIDUALS AT RISK FROM RECEPTIVE VAGINAL SEX |
EQ 25MG BASE | VEMLIDY | GILEAD SCIENCES INC | N208464 | Nov. 10, 2016 | RX | TABLET | ORAL | Feb. 4, 2023 | INFORMATION ADDED TO THE LABELING TO DESCRIBE STUDY GS-US-320-4018 IN VIROLOGICALLY SUPPRESSED ADULTS W/ CHRONIC HEP B INFECTION WHO SWITCHED FROM TENOFOVIR DISOPROXIL FUMARATE TO TENOFOVIR ALAFENAMIDE |
EQ 30MG BASE;120MG;EQ 15MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Oct. 7, 2021 | RX | TABLET | ORAL | Feb. 7, 2023 | NEW CHEMICAL ENTITY |
EQ 50MG BASE;200MG;EQ 25MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Feb. 7, 2018 | RX | TABLET | ORAL | Feb. 7, 2023 | NEW CHEMICAL ENTITY |
EQ 25MG BASE | VEMLIDY | GILEAD SCIENCES INC | N208464 | Nov. 10, 2016 | RX | TABLET | ORAL | Aug. 22, 2023 | INFORMATION ADDED TO THE LABELING TO DESCRIBE STUDY GS-US-320-4035 IN VIROLOGICALLY SUPPRESSED ADULTS W/ CHRONIC HEP B INFECTION WHO SWITCHED FROM TENOFOVIR DISOPROXIL FUMARATE TO TENOFOVIR ALFAENAMIDE |
EQ 50MG BASE;200MG;EQ 25MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Feb. 7, 2018 | RX | TABLET | ORAL | Feb. 24, 2024 | LABELING REVISIONS RELATED TO CLINICAL STUDIES |
200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | Sept. 28, 2024 | IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, FOR THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 35KG |
200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | Sept. 28, 2024 | IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS OTHER THAN PROTEASE INHIBITORS THAT REQUIRE A CYP3A INHIBITOR, FOR THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 25KG AND LESS THAN 35KG |
EQ 25MG BASE | VEMLIDY | GILEAD SCIENCES INC | N208464 | Nov. 10, 2016 | RX | TABLET | ORAL | Oct. 17, 2025 | NEW PATIENT POPULATION |
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 | 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 |
None
ID | Source |
---|---|
EL9943AG5J | UNII |
D10428 | KEGG_DRUG |
1392275-56-7 | SECONDARY_CAS_RN |
4021279 | VANDF |
4035188 | VANDF |
C3713958 | UMLSCUI |
CHEBI:90926 | CHEBI |
CHEBI:63625 | 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 |
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 |
D000068698 | MESH_DESCRIPTOR_UI |
464205 | PUBCHEM_CID |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Symtuza | HUMAN PRESCRIPTION DRUG LABEL | 4 | 59676-800 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 34 sections |
Symtuza | HUMAN PRESCRIPTION DRUG LABEL | 4 | 59676-800 | TABLET, FILM COATED | 10 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 |
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 | 61958-2501 | 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 | 61958-2505 | TABLET | 15 mg | ORAL | NDA | 35 sections |
DESCOVY | HUMAN PRESCRIPTION DRUG LABEL | 2 | 70518-0230 | TABLET | 25 mg | ORAL | NDA | 34 sections |
Genvoya | HUMAN PRESCRIPTION DRUG LABEL | 4 | 70518-0568 | TABLET | 10 mg | ORAL | NDA | 31 sections |
Biktarvy | HUMAN PRESCRIPTION DRUG LABEL | 3 | 70518-3080 | TABLET | 25 mg | ORAL | NDA | 34 sections |