tenofovir alafenamide Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antivirals phosphonic acid derivatives 4944 379270-37-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • GS 7340
  • tenofovir alagenamide
  • tenofovir alafenamide
  • tenofovir alafenamide fumarate
  • GS-7340
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
  • Molecular weight: 476.47
  • Formula: C21H29N6O5P
  • CLOGP: 2.18
  • LIPINSKI: 1
  • HAC: 11
  • HDO: 2
  • TPSA: 143.48
  • ALOGS: -3.30
  • ROTB: 12

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
25 mg O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Maternal exposure during pregnancy 395.32 22.69 207 3987 155432 53189440
Abortion spontaneous 171.00 22.69 80 4114 46555 53298317
Blood HIV RNA increased 142.74 22.69 28 4166 777 53344095
Weight increased 140.60 22.69 121 4073 204446 53140426
Viral load increased 98.85 22.69 23 4171 1452 53343420
Genotype drug resistance test positive 89.57 22.69 18 4176 566 53344306
Foetal exposure during pregnancy 84.06 22.69 45 4149 34670 53310202
Product dispensing error 79.45 22.69 30 4164 10210 53334662
Drug interaction 78.28 22.69 91 4103 219238 53125634
Product use complaint 75.50 22.69 20 4174 2150 53342722
Gastrointestinal tube insertion 56.50 22.69 14 4180 1153 53343719
Gastrostomy 49.07 22.69 11 4183 587 53344285
Immune reconstitution inflammatory syndrome 47.08 22.69 18 4176 6328 53338544
Exposure during pregnancy 44.73 22.69 52 4142 124808 53220064
Treatment noncompliance 43.66 22.69 29 4165 33006 53311866
Product storage error 43.35 22.69 21 4173 13109 53331763
CD4 lymphocytes decreased 42.11 22.69 12 4182 1689 53343183
Abortion induced 40.90 22.69 19 4175 10807 53334065
Spina bifida 31.04 22.69 8 4186 772 53344100
Peripheral nerve injury 30.04 22.69 7 4187 444 53344428
Drug resistance 29.99 22.69 19 4175 19943 53324929
Congenital hydrocephalus 29.66 22.69 6 4188 195 53344677
Viral mutation identified 27.27 22.69 9 4185 2065 53342807
Liver transplant 25.64 22.69 9 4185 2485 53342387
Ovarian neoplasm 25.17 22.69 7 4187 902 53343970
Dysphagia 25.06 22.69 32 4162 84365 53260507
Hepatitis B DNA increased 23.35 22.69 5 4189 215 53344657
Pre-eclampsia 23.15 22.69 12 4182 8635 53336237

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Viral load increased 485.87 17.44 128 10945 3022 32499431
Product storage error 358.13 17.44 122 10951 7056 32495397
Blood HIV RNA increased 284.54 17.44 73 11000 1544 32500909
Weight increased 270.20 17.44 225 10848 83438 32419015
Immune reconstitution inflammatory syndrome 259.98 17.44 104 10969 9455 32492998
Gastrointestinal tube insertion 216.21 17.44 57 11016 1345 32501108
Product dispensing error 205.83 17.44 79 10994 6426 32496027
CD4 lymphocytes decreased 140.33 17.44 45 11028 2145 32500308
Genotype drug resistance test positive 111.67 17.44 36 11037 1745 32500708
Syphilis 109.87 17.44 28 11045 575 32501878
HIV infection 89.22 17.44 31 11042 1895 32500558
Viraemia 85.23 17.44 27 11046 1236 32501217
Product dose omission issue 80.18 17.44 133 10940 102442 32400011
Gastrostomy 79.75 17.44 23 11050 762 32501691
Virologic failure 75.32 17.44 33 11040 3754 32498699
Product use complaint 72.77 17.44 24 11049 1250 32501203
Intentional dose omission 62.66 17.44 25 11048 2249 32500204
Treatment noncompliance 61.47 17.44 60 11013 27142 32475311
Abnormal dreams 59.97 17.44 37 11036 8527 32493926
Rash 59.48 17.44 181 10892 209152 32293301
Endotracheal intubation 56.24 17.44 24 11049 2561 32499892
Drug interaction 54.07 17.44 180 10893 218005 32284448
Therapy cessation 51.31 17.44 43 11030 15970 32486483
Product dispensing issue 49.73 17.44 10 11063 65 32502388
Fanconi syndrome acquired 46.19 17.44 20 11053 2210 32500243
HIV test positive 45.79 17.44 12 11061 276 32502177
HIV viraemia 45.73 17.44 10 11063 102 32502351
Fat tissue increased 44.89 17.44 13 11060 437 32502016
Dysphagia 44.36 17.44 77 10996 61399 32441054
Hypothalamic pituitary adrenal axis suppression 44.11 17.44 11 11062 206 32502247
Product temperature excursion issue 43.57 17.44 7 11066 8 32502445
Insomnia 42.82 17.44 101 10972 100247 32402206
Wrong technique in product usage process 41.03 17.44 55 11018 35004 32467449
Drug resistance 39.88 17.44 44 11029 22921 32479532
Nightmare 39.40 17.44 34 11039 13132 32489321
Nausea 36.92 17.44 210 10863 320639 32181814
Dyslipidaemia 36.54 17.44 25 11048 6858 32495595
Intercepted product dispensing error 35.87 17.44 8 11065 90 32502363
Liver function test increased 34.71 17.44 31 11042 12529 32489924
Insurance issue 34.17 17.44 13 11060 1029 32501424
Inability to afford medication 33.97 17.44 13 11060 1046 32501407
Headache 33.66 17.44 144 10929 196053 32306400
Circumstance or information capable of leading to medication error 33.00 17.44 15 11058 1860 32500593
Blood triglycerides increased 32.55 17.44 32 11041 14587 32487866
Major depression 30.49 17.44 19 11054 4452 32498001
Hypotension 30.39 17.44 18 11055 216092 32286361
Mechanical ventilation 29.87 17.44 14 11059 1861 32500592
Hepatitis B DNA increased 29.70 17.44 10 11063 555 32501898
Malignant anorectal neoplasm 28.97 17.44 6 11067 46 32502407
Hemiparaesthesia 27.92 17.44 6 11067 56 32502397
Suicidal ideation 27.84 17.44 48 11025 38035 32464418
Renal tubular dysfunction 27.47 17.44 9 11064 459 32501994
Alopecia 26.54 17.44 34 11039 20696 32481757
Schizophreniform disorder 24.95 17.44 6 11067 96 32502357
Viral load abnormal 24.95 17.44 6 11067 96 32502357
Blood HIV RNA 24.93 17.44 5 11068 32 32502421
HIV-associated neurocognitive disorder 24.84 17.44 8 11065 386 32502067
Glomerular filtration rate decreased 24.79 17.44 26 11047 12785 32489668
Pneumonia 23.63 17.44 54 11019 355198 32147255
Hepatitis A 22.96 17.44 8 11065 493 32501960
Glucocorticoid deficiency 22.42 17.44 7 11066 305 32502148
Hepatitis B 22.34 17.44 18 11055 6323 32496130
Osteoporosis 22.29 17.44 24 11049 12158 32490295
Mental disorder 22.08 17.44 26 11047 14522 32487931
Therapy change 21.73 17.44 13 11060 2832 32499621
COVID-19 21.65 17.44 39 11034 31976 32470477
Hospitalisation 21.63 17.44 50 11023 48921 32453532
Heart transplant rejection 21.54 17.44 10 11063 1301 32501152
Multiple-drug resistance 20.72 17.44 14 11059 3761 32498692
Abdominal distension 20.10 17.44 50 11023 51245 32451208
Blood creatinine increased 19.99 17.44 75 10998 96057 32406396
Sleep disorder 19.91 17.44 34 11039 26718 32475735
Pulmonary venous thrombosis 19.42 17.44 5 11068 107 32502346
Lung transplant rejection 19.18 17.44 8 11065 806 32501647
Cardiac failure congestive 19.13 17.44 3 11070 84849 32417604
Acquired immunodeficiency syndrome 19.10 17.44 7 11066 499 32501954
Physical product label issue 18.88 17.44 3 11070 3 32502450
Renal tubular disorder 18.82 17.44 15 11058 5187 32497266
Depression 18.77 17.44 74 10999 96986 32405467
Product distribution issue 18.66 17.44 6 11067 288 32502165
Lipids increased 17.71 17.44 8 11065 977 32501476

Pharmacologic Action:

SourceCodeDescription
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 anti-virus drug
CHEBI has role CHEBI:53756 reverse transcriptase inhibitor
CHEBI has role CHEBI:50266 Prodrugs

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Human immunodeficiency virus infection indication 86406008 DOID:526

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.86 Basic
pKa2 3.96 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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 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

Bioactivity Summary:

None

External reference:

IDSource
EL9943AG5J UNII
D10428 KEGG_DRUG
1392275-56-7 SECONDARY_CAS_RN
4021279 VANDF
4035188 VANDF
C3713958 UMLSCUI
CHEBI:90926 CHEBI
CHEBI:63625 CHEBI
CHEMBL2107825 ChEMBL_ID
9574768 PUBCHEM_CID
DB09299 DRUGBANK_ID
CHEMBL2364637 ChEMBL_ID
C442442 MESH_SUPPLEMENTAL_RECORD_UI
464205 PUBCHEM_CID
DB14126 DRUGBANK_ID
9980 INN_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
D000068698 MESH_DESCRIPTOR_UI
C0384228 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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
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