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

Stem definitionDrug idCAS RN
antivirals, hepatitis C Virus (HCV) NS5A inhibitors 5154 1377049-84-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • velpatasvir
  • GS-5816
  • GS5816
pan-genotypic NS5A inhibitor for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection
  • Molecular weight: 883.02
  • Formula: C49H54N8O8
  • CLOGP: 6.41
  • LIPINSKI: 3
  • HAC: 16
  • HDO: 4
  • TPSA: 193.10
  • ALOGS: -5.21
  • ROTB: 13

  • Status: ONP

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

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
July 6, 2016 EMA GILEAD SCIENCES IRELAND UC
June 28, 2016 FDA GILEAD SCIENCES INC
Jan. 8, 2019 PMDA Gilead Sciences K.K.

FDA Adverse Event Reporting System (Female)

None

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 J05AP55 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HCV infections
ATC J05AP56 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HCV infections
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000998 Antiviral Agents
FDA MoA N0000185503 P-Glycoprotein Inhibitors
FDA MoA N0000190107 Organic Anion Transporting Polypeptide 1B1 Inhibitors
FDA MoA N0000190108 Organic Anion Transporting Polypeptide 1B3 Inhibitors
FDA MoA N0000190109 Organic Anion Transporting Polypeptide 2B1 Inhibitors
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:85185 hepatitis C virus nonstructural protein 5A inhibitors

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Chronic hepatitis C indication 128302006
Compensated cirrhosis indication 371139006
Decompensated cirrhosis of liver indication 716203000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.48 acidic
pKa2 12.26 acidic
pKa3 12.93 acidic
pKa4 13.17 acidic
pKa5 6.49 Basic
pKa6 5.8 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8334270 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8580765 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8735372 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 9085573 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8334270 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8580765 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8735372 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 9085573 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8334270 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8334270 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8580765 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8580765 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8735372 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8735372 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8957046 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8957046 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9085573 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9085573 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9585906 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9585906 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8334270 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8580765 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8735372 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 9085573 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8334270 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8580765 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8735372 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 9085573 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 7964580 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8633309 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8889159 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 7964580 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8633309 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8889159 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 7964580 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 7964580 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8633309 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8633309 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8889159 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8889159 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 7964580 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8633309 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8889159 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 7964580 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8633309 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8889159 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 9284342 Sept. 13, 2030 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 9284342 Sept. 13, 2030 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9284342 Sept. 13, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9284342 Sept. 13, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 9284342 Sept. 13, 2030 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 9284342 Sept. 13, 2030 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8618076 Dec. 11, 2030 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8618076 Dec. 11, 2030 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8618076 Dec. 11, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8618076 Dec. 11, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8618076 Dec. 11, 2030 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8618076 Dec. 11, 2030 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8575135 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8921341 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8940718 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8575135 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8921341 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8940718 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8575135 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8575135 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8921341 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8921341 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8940718 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8940718 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8575135 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8921341 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8940718 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8575135 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8921341 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8940718 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 10086011 Jan. 30, 2034 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 11116783 Jan. 30, 2034 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 10086011 Jan. 30, 2034 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 11116783 Jan. 30, 2034 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 11116783 Jan. 30, 2034 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 11116783 Jan. 30, 2034 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 11116783 Jan. 30, 2034 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 11116783 Jan. 30, 2034 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 11338007 June 1, 2037 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 11338007 June 1, 2037 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL March 19, 2023 NEW STRENGTH
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL March 19, 2023 NEW PATIENT POPULATION
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL May 15, 2023 PEDIATRIC EXCLUSIVITY
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL July 14, 2023 INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL July 14, 2023 INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL Sept. 19, 2023 PEDIATRIC EXCLUSIVITY
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL Sept. 19, 2023 PEDIATRIC EXCLUSIVITY
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL Jan. 14, 2024 PEDIATRIC EXCLUSIVITY
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL Jan. 14, 2024 PEDIATRIC EXCLUSIVITY
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL April 27, 2025 UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL April 27, 2025 UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL April 27, 2025 UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL April 27, 2025 UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL March 19, 2027 TX OF PED PTS 6 YRS OF AGE & OLDER OR WEIGHING AT LEAST 17 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL March 19, 2027 TX OF PED PTS 6 YRS OF AGE & OLDER OR WEIGHING AT LEAST 17 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL Sept. 19, 2027 PEDIATRIC EXCLUSIVITY
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL Sept. 19, 2027 PEDIATRIC EXCLUSIVITY
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL June 10, 2028 FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 6 YEARS OF AGE WEIGHING LESS THAN 17 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL June 10, 2028 FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 6 YEARS OF AGE WEIGHING LESS THAN 17 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL June 10, 2028 FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 6 YEARS OF AGE WEIGHING LESS THAN 17 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL June 10, 2028 FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 6 YEARS OF AGE WEIGHING LESS THAN 17 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL Dec. 10, 2028 PEDIATRIC EXCLUSIVITY
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL Dec. 10, 2028 PEDIATRIC EXCLUSIVITY
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL Dec. 10, 2028 PEDIATRIC EXCLUSIVITY
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL Dec. 10, 2028 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Genome polyprotein Polyprotein INHIBITOR EC50 11.10 DRUG LABEL DRUG LABEL
Genome polyprotein Polyprotein INHIBITOR EC50 10.80 DRUG LABEL DRUG LABEL
Genome polyprotein Polyprotein INHIBITOR EC50 10.85 DRUG LABEL DRUG LABEL
Genome polyprotein Polyprotein INHIBITOR EC50 10.98 DRUG LABEL DRUG LABEL
Genome polyprotein Polyprotein INHIBITOR EC50 11.05 DRUG LABEL DRUG LABEL
Genome polyprotein Polyprotein INHIBITOR EC50 11.40 DRUG LABEL DRUG LABEL
Genome polyprotein Polyprotein INHIBITOR EC50 11.40 DRUG LABEL DRUG LABEL
Genome polyprotein Polyprotein INHIBITOR EC50 10.43 DRUG LABEL DRUG LABEL
Nonstructural protein 5A Unclassified EC50 11 CHEMBL

External reference:

IDSource
KCU0C7RS7Z UNII
4035867 VANDF
C4079582 UMLSCUI
CHEBI:133009 CHEBI
CHEMBL3545062 ChEMBL_ID
67683363 PUBCHEM_CID
DB11613 DRUGBANK_ID
9960 INN_ID
11269 IUPHAR_LIGAND_ID
1799206 RXNORM
31777 MMSL
d08455 MMSL
016909 NDDF
719641001 SNOMEDCT_US
816105002 SNOMEDCT_US
C000604171 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Epclusa HUMAN PRESCRIPTION DRUG LABEL 2 61958-2201 TABLET, FILM COATED 100 mg ORAL NDA 36 sections
Epclusa HUMAN PRESCRIPTION DRUG LABEL 2 61958-2201 TABLET, FILM COATED 100 mg ORAL NDA 36 sections
Epclusa Access HUMAN PRESCRIPTION DRUG LABEL 2 61958-2202 TABLET, FILM COATED 100 mg ORAL Export only 31 sections
Epclusa HUMAN PRESCRIPTION DRUG LABEL 2 61958-2203 TABLET, FILM COATED 50 mg ORAL NDA 36 sections
Epclusa HUMAN PRESCRIPTION DRUG LABEL 2 61958-2203 TABLET, FILM COATED 50 mg ORAL NDA 36 sections
Epclusa HUMAN PRESCRIPTION DRUG LABEL 2 61958-2204 PELLET 50 mg ORAL NDA 36 sections
Epclusa HUMAN PRESCRIPTION DRUG LABEL 2 61958-2204 PELLET 50 mg ORAL NDA 36 sections
Epclusa HUMAN PRESCRIPTION DRUG LABEL 2 61958-2205 PELLET 37.50 mg ORAL NDA 36 sections
Epclusa HUMAN PRESCRIPTION DRUG LABEL 2 61958-2205 PELLET 37.50 mg ORAL NDA 36 sections
Vosevi HUMAN PRESCRIPTION DRUG LABEL 3 61958-2401 TABLET, FILM COATED 100 mg ORAL NDA 34 sections
Sofosbuvir and Velpatasvir HUMAN PRESCRIPTION DRUG LABEL 2 72626-2701 TABLET, FILM COATED 100 mg ORAL NDA AUTHORIZED GENERIC 35 sections
Sofosbuvir and Velpatasvir HUMAN PRESCRIPTION DRUG LABEL 2 72626-2701 TABLET, FILM COATED 100 mg ORAL NDA AUTHORIZED GENERIC 35 sections