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

Stem definitionDrug idCAS RN
Hepatitis Virus C (HVC) protease inhibitors 5243 1365970-03-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • glecaprevir
  • ABT-493
  • A-1282576.0
Glecaprevir is an inhibitor of the HCV NS3/4A protease, which is necessary for the proteolytic cleavage of the HCV encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication. In a biochemical assay, glecaprevir inhibited the proteolytic activity of recombinant NS3/4A enzymes from clinical isolates of HCV genotypes 1a, 1b, 2a, 2b, 3a, 4a, 5a, and 6a with IC50 values ranging from 3.5 to 11.3 nM.
  • Molecular weight: 838.87
  • Formula: C38H46F4N6O9S
  • CLOGP: 4.10
  • LIPINSKI: 2
  • HAC: 15
  • HDO: 3
  • TPSA: 195.22
  • ALOGS: -4.26
  • ROTB: 6

  • Status: ONP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
July 26, 2017 EMA AbbVie Deutschland GmbH & Co. KG
Aug. 3, 2017 FDA ABBVIE INC
Sept. 27, 2017 PMDA AbbVie GK

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 J05AP57 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HCV infections
FDA MoA N0000182138 Cytochrome P450 1A2 Inhibitors
FDA MoA N0000182638 HCV NS3/4A Protease Inhibitors
FDA EPC N0000182639 Hepatitis C Virus NS3/4A Protease Inhibitor
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 N0000190113 Breast Cancer Resistance Protein Inhibitors
FDA MoA N0000190114 Cytochrome P450 3A Inhibitors
FDA MoA N0000191272 UGT1A1 Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Chronic hepatitis C indication 128302006
Compensated cirrhosis indication 371139006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.64 acidic
pKa2 0.86 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL 10028937 June 10, 2030 TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL 10028937 June 10, 2030 TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL 10039754 June 10, 2030 TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL 10039754 June 10, 2030 TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG
50MG;20MG/PACKET MAVYRET ABBVIE INC N215110 June 10, 2021 RX PELLETS ORAL 10028937 June 10, 2030 TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN PEDIATRIC PATIENTS 3 TO LESS THAN 12 YEARS OF AGE OR WEIGHING LESS THAN 45 KG
50MG;20MG/PACKET MAVYRET ABBVIE INC N215110 June 10, 2021 RX PELLETS ORAL 10039754 June 10, 2030 TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN PEDIATRIC PATIENTS 3 TO LESS THAN 12 YEARS OF AGE OR WEIGHING LESS THAN 45 KG
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL 9586978 Nov. 6, 2030 TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL 9586978 Nov. 6, 2030 TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG
50MG;20MG/PACKET MAVYRET ABBVIE INC N215110 June 10, 2021 RX PELLETS ORAL 9586978 Nov. 6, 2030 TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN PEDIATRIC PATIENTS 3 TO LESS THAN 12 YEARS OF AGE OR WEIGHING LESS THAN 45 KG
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL 8648037 Jan. 19, 2032 TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL 8648037 Jan. 19, 2032 TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG
50MG;20MG/PACKET MAVYRET ABBVIE INC N215110 June 10, 2021 RX PELLETS ORAL 8648037 Jan. 19, 2032 TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN PEDIATRIC PATIENTS 3 TO LESS THAN 12 YEARS OF AGE OR WEIGHING LESS THAN 45 KG
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL 10286029 March 14, 2034 TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG
50MG;20MG/PACKET MAVYRET ABBVIE INC N215110 June 10, 2021 RX PELLETS ORAL 10286029 March 14, 2034 TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN PEDIATRIC PATIENTS 3 TO LESS THAN 12 YEARS OF AGE OR WEIGHING LESS THAN 45 KG

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL April 30, 2022 NEW PATIENT POPULATION
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL Aug. 3, 2022 NEW CHEMICAL ENTITY
50MG;20MG/PACKET MAVYRET ABBVIE INC N215110 June 10, 2021 RX PELLETS ORAL Aug. 3, 2022 NEW CHEMICAL ENTITY
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL Sept. 26, 2022 EIGHT-WEEK DOSING REGIMEN FOR THE TREATMENT OF GENOTYPES 1, 2, 3, 4, 5, AND 6, CHRONIC HEPATITIS C VIRUS INFECTION IN TREATMENT-NAIVE SUBJECTS WITH COMPENSATED CIRRHOSIS BASED ON THE RESULTS FROM THE EXPEDITION-8 STUDY
50MG;20MG/PACKET MAVYRET ABBVIE INC N215110 June 10, 2021 RX PELLETS ORAL Sept. 26, 2022 EIGHT-WEEK DOSING REGIMEN FOR THE TREATMENT OF GENOTYPES 1, 2, 3, 4, 5, AND 6, CHRONIC HEPATITIS C VIRUS INFECTION IN TREATMENT-NAIVE SUBJECTS WITH COMPENSATED CIRRHOSIS BASED ON THE RESULTS FROM THE EXPEDITION-8 STUDY
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL Oct. 30, 2022 PEDIATRIC EXCLUSIVITY
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL Feb. 3, 2023 PEDIATRIC EXCLUSIVITY
50MG;20MG/PACKET MAVYRET ABBVIE INC N215110 June 10, 2021 RX PELLETS ORAL Feb. 3, 2023 PEDIATRIC EXCLUSIVITY
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL March 26, 2023 PEDIATRIC EXCLUSIVITY
50MG;20MG/PACKET MAVYRET ABBVIE INC N215110 June 10, 2021 RX PELLETS ORAL March 26, 2023 PEDIATRIC EXCLUSIVITY
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL April 10, 2023 INFORMATION ADDED TO THE LABELING REGARDING SAFETY AND EFFICACY IN SUBJECTS WITH HCV SUBTYPE 3B INFECTION
50MG;20MG/PACKET MAVYRET ABBVIE INC N215110 June 10, 2021 RX PELLETS ORAL April 10, 2023 INFORMATION ADDED TO THE LABELING REGARDING SAFETY AND EFFICACY IN SUBJECTS WITH HCV SUBTYPE 3B INFECTION
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL Oct. 10, 2023 PEDIATRIC EXCLUSIVITY
50MG;20MG/PACKET MAVYRET ABBVIE INC N215110 June 10, 2021 RX PELLETS ORAL Oct. 10, 2023 PEDIATRIC EXCLUSIVITY
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL April 30, 2026 TREATMENT OF PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1,2,3,4,5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A)
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL April 30, 2026 TREATMENT OF PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG WITH HCV GENOTYPE 1 INFECTION, WHO PREVIOUSLY HAVE BEEN TREATED WITH A REGIMEN CONTAINING AN HCV NS5A INHIBITOR OR AN NS3/4A PROTEASE INHIBITOR (PI), BUT NOT BOTH
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL Oct. 30, 2026 PEDIATRIC EXCLUSIVITY
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL June 10, 2028 FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A); AND TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH HCV GENOTYPE 1 INFECTION, WHO PREVIOUSLY HAVE BEEN TREATED WITH A REGIMEN CONTAINING AN HCV NS5A INHIBITOR OR AN NS3/4A PROTEASE INHIBITOR (PI), B
50MG;20MG/PACKET MAVYRET ABBVIE INC N215110 June 10, 2021 RX PELLETS ORAL June 10, 2028 FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A); AND TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH HCV GENOTYPE 1 INFECTION, WHO PREVIOUSLY HAVE BEEN TREATED WITH A REGIMEN CONTAINING AN HCV NS5A INHIBITOR OR AN NS3/4A PROTEASE INHIBITOR (PI), B
100MG;40MG MAVYRET ABBVIE INC N209394 Aug. 3, 2017 RX TABLET ORAL Dec. 10, 2028 PEDIATRIC EXCLUSIVITY
50MG;20MG/PACKET MAVYRET ABBVIE INC N215110 June 10, 2021 RX PELLETS ORAL Dec. 10, 2028 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

None

External reference:

IDSource
K6BUU8J72P UNII
C4519536 UMLSCUI
O31 PDB_CHEM_ID
CHEMBL3545363 ChEMBL_ID
66828839 PUBCHEM_CID
DB13879 DRUGBANK_ID
D10814 KEGG_DRUG
11267 IUPHAR_LIGAND_ID
1940635 RXNORM
33000 MMSL
d08633 MMSL
736837006 SNOMEDCT_US
816101006 SNOMEDCT_US
4036871 VANDF
017295 NDDF
C000612853 MESH_SUPPLEMENTAL_RECORD_UI
10261 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Mavyret HUMAN PRESCRIPTION DRUG LABEL 2 0074-2600 PELLET 50 mg ORAL NDA 34 sections
Mavyret HUMAN PRESCRIPTION DRUG LABEL 2 0074-2625 TABLET, FILM COATED 100 mg ORAL NDA 34 sections