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

Stem definition	Drug id	CAS RN
antivirals, hepatitis C Virus (HCV) NS5A inhibitors	5244	1353900-92-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: pibrentasvir ABT-530 A-1325912.0	Pibrentasvir is an inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly. The mechanism of action of pibrentasvir has been characterized based on cell culture antiviral activity and drug resistance mapping studies. Molecular weight: 1113.20 Formula: C57H65F5N10O8 CLOGP: 7.92 LIPINSKI: 3 HAC: 18 HDO: 4 TPSA: 199.58 ALOGS: -5.30 ROTB: 17 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

pibrentasvir
ABT-530
A-1325912.0

Pibrentasvir is an inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly. The mechanism of action of pibrentasvir has been characterized based on cell culture antiviral activity and drug resistance mapping studies.

Molecular weight: 1113.20
Formula: C57H65F5N10O8
CLOGP: 7.92
LIPINSKI: 3
HAC: 18
HDO: 4
TPSA: 199.58
ALOGS: -5.30
ROTB: 17

Status: ONP

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

Drug dosage:

None

ADMET properties:

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

Approvals:

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

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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:

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Source	Code	Description
ATC	J05AP57	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections
FDA EPC	N0000191256	Hepatitis C Virus NS5A Inhibitor
FDA MoA	N0000182138	Cytochrome P450 1A2 Inhibitors
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

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

Disease	Relation	SNOMED_ID	DOID
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

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.04	acidic
pKa2	11.64	acidic
pKa3	12.69	acidic
pKa4	13.29	acidic
pKa5	5.17	Basic
pKa6	4.56	Basic
pKa7	1.2	Basic

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG;40MG	MAVYRET	ABBVIE	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	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	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	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
100MG;40MG	MAVYRET	ABBVIE	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	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
100MG;40MG	MAVYRET	ABBVIE	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	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
100MG;40MG	MAVYRET	ABBVIE	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
100MG;40MG	MAVYRET	ABBVIE	N209394	Aug. 3, 2017	RX	TABLET	ORAL	11484534	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

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG;40MG	MAVYRET	ABBVIE	N209394	Aug. 3, 2017	RX	TABLET	ORAL	Feb. 3, 2023	PEDIATRIC EXCLUSIVITY
100MG;40MG	MAVYRET	ABBVIE	N209394	Aug. 3, 2017	RX	TABLET	ORAL	March 26, 2023	PEDIATRIC EXCLUSIVITY
100MG;40MG	MAVYRET	ABBVIE	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
100MG;40MG	MAVYRET	ABBVIE	N209394	Aug. 3, 2017	RX	TABLET	ORAL	Oct. 10, 2023	PEDIATRIC EXCLUSIVITY
100MG;40MG	MAVYRET	ABBVIE	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	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	N209394	Aug. 3, 2017	RX	TABLET	ORAL	Oct. 30, 2026	PEDIATRIC EXCLUSIVITY
100MG;40MG	MAVYRET	ABBVIE	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
100MG;40MG	MAVYRET	ABBVIE	N209394	Aug. 3, 2017	RX	TABLET	ORAL	Dec. 10, 2028	PEDIATRIC EXCLUSIVITY
50MG;20MG/PACKET	MAVYRET	ABBVIE	N215110	June 10, 2021	RX	PELLETS	ORAL	Feb. 3, 2023	PEDIATRIC EXCLUSIVITY

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Nonstructural protein 5A	Unclassified		Q5L478_9HEPC		EC50	10.19		CHEMBL
Genome polyprotein [Cleaved into: Core protein p21	Unclassified		POLG_HCVCO		EC50	9.70		CHEMBL

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External reference:

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ID	Source
017296	NDDF
10260	INN_ID
11268	IUPHAR_LIGAND_ID
1940636	RXNORM
2WU922TK3L	UNII
33001	MMSL
4036872	VANDF
58031952	PUBCHEM_CID
736836002	SNOMEDCT_US
816102004	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Mavyret	HUMAN PRESCRIPTION DRUG LABEL	2	0074-2600	PELLET	20 mg	ORAL	NDA	34 sections
Mavyret	HUMAN PRESCRIPTION DRUG LABEL	2	0074-2600	PELLET	20 mg	ORAL	NDA	34 sections
Mavyret	HUMAN PRESCRIPTION DRUG LABEL	2	0074-2600	PELLET	20 mg	ORAL	NDA	34 sections
Mavyret	HUMAN PRESCRIPTION DRUG LABEL	2	0074-2625	TABLET, FILM COATED	40 mg	ORAL	NDA	34 sections
Mavyret	HUMAN PRESCRIPTION DRUG LABEL	2	0074-2625	TABLET, FILM COATED	40 mg	ORAL	NDA	34 sections
Mavyret	HUMAN PRESCRIPTION DRUG LABEL	2	0074-2625	TABLET, FILM COATED	40 mg	ORAL	NDA	34 sections

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