elbasvir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antivirals, hepatitis C Virus (HCV) NS5A inhibitors 5080 1370468-36-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • elbasvir
  • MK-8742
  • MK 8742
inhibits NS5A protein of hepatitis C virus
  • Molecular weight: 882.04
  • Formula: C49H55N9O7
  • CLOGP: 6.66
  • LIPINSKI: 3
  • HAC: 16
  • HDO: 4
  • TPSA: 188.80
  • ALOGS: -5.30
  • ROTB: 13

  • Status: ONP

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

Drug dosage:

DoseUnitRoute
50 mg O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 28, 2016 FDA MERCK SHARP DOHME

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
Pancreas transplant rejection 79.32 53.20 7 8 131 50604978

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J05AP10 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HCV infections
ATC J05AP54 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HCV infections
FDA MoA N0000190113 Breast Cancer Resistance Protein Inhibitors
FDA EPC N0000191256 Hepatitis C Virus NS5A Inhibitor
CHEBI has role CHEBI:36044 antiviral drugs
CHEBI has role CHEBI:62868 hepatoprotective agents
CHEBI has role CHEBI:85185 hepatitis C virus nonstructural protein 5A inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Chronic hepatitis C indication 128302006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.46 acidic
pKa2 12.98 acidic
pKa3 13.06 acidic
pKa4 13.59 acidic
pKa5 5.64 Basic
pKa6 5.03 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
50MG;100MG ZEPATIER MERCK SHARP DOHME N208261 Jan. 28, 2016 RX TABLET ORAL 7973040 July 24, 2029 TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS
50MG;100MG ZEPATIER MERCK SHARP DOHME N208261 Jan. 28, 2016 RX TABLET ORAL 8871759 May 4, 2031 TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
50MG;100MG ZEPATIER MERCK SHARP DOHME N208261 Jan. 28, 2016 RX TABLET ORAL Dec. 9, 2024 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Genome polyprotein Polyprotein INHIBITOR EC50 11.52 DRUG LABEL DRUG LABEL
Genome polyprotein Polyprotein INHIBITOR EC50 11.40 DRUG LABEL DRUG LABEL
Genome polyprotein Polyprotein INHIBITOR EC50 12.52 DRUG LABEL DRUG LABEL
Nonstructural protein 5A Unclassified EC50 10.70 CHEMBL

External reference:

IDSource
632L571YDK UNII
D10625 KEGG_DRUG
4035373 VANDF
C4080052 UMLSCUI
CHEBI:132967 CHEBI
CHEMBL3039514 ChEMBL_ID
71661251 PUBCHEM_CID
DB11574 DRUGBANK_ID
9851 INN_ID
C000589335 MESH_SUPPLEMENTAL_RECORD_UI
1734628 RXNORM
31482 MMSL
d08416 MMSL
716042006 SNOMEDCT_US
816100007 SNOMEDCT_US
016673 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ZEPATIER HUMAN PRESCRIPTION DRUG LABEL 2 0006-3074 TABLET, FILM COATED 50 mg ORAL NDA 31 sections
ZEPATIER HUMAN PRESCRIPTION DRUG LABEL 2 0006-3074 TABLET, FILM COATED 50 mg ORAL NDA 31 sections