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

Stem definition	Drug id	CAS RN
antivirals, hepatitis C Virus (HCV) NS5A inhibitors	5080	1370468-36-2

Description:

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

Molecule

Description

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: OFP

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

Drug dosage:

Dose	Unit	Route
50	mg	O

ADMET properties:

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Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	4	Bocci G, Oprea TI, Benet LZ
BA (Bioavailability)	0.32 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

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Approvals:

Date	Agency	Company	Orphan
Jan. 28, 2016	FDA	MERCK SHARP DOHME

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Liver injury	83.79	45.23	42	2302	60478	63426200
Psoriatic arthropathy	67.54	45.23	42	2302	91478	63395200
Lupus vulgaris	61.46	45.23	18	2326	5976	63480702
Eye injury	54.19	45.23	14	2330	2925	63483753
Glossodynia	52.19	45.23	47	2297	178829	63307849
Pemphigus	51.11	45.23	47	2297	183679	63302999
Systemic lupus erythematosus	45.98	45.23	47	2297	208871	63277807
Ulcer haemorrhage	45.71	45.23	14	2330	5408	63481270

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FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pancreas transplant rejection	47.76	30.82	7	685	318	79743378

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
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
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
FDA EPC	N0000191256	Hepatitis C Virus NS5A Inhibitor
FDA MoA	N0000190113	Breast Cancer Resistance Protein 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

🐶 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	12.46	acidic
pKa2	12.98	acidic
pKa3	13.06	acidic
pKa4	13.59	acidic
pKa5	5.64	Basic
pKa6	5.03	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
50MG;100MG	ZEPATIER	MSD SUB MERCK	N208261	Jan. 28, 2016	RX	TABLET	ORAL	7973040	July 24, 2029	TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS
50MG;100MG	ZEPATIER	MSD SUB MERCK	N208261	Jan. 28, 2016	RX	TABLET	ORAL	8871759	May 4, 2031	TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS

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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
50MG;100MG	ZEPATIER	MSD SUB MERCK	N208261	Jan. 28, 2016	RX	TABLET	ORAL	Dec. 9, 2024	NEW PATIENT POPULATION

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Bioactivity Summary:

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Target	Class	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Genome polyprotein	Polyprotein	POLG_HCVBK	INHIBITOR	EC50	11.52	DRUG LABEL	DRUG LABEL
Genome polyprotein	Polyprotein	POLG_HCVH	INHIBITOR	EC50	11.40	DRUG LABEL	DRUG LABEL
Genome polyprotein	Polyprotein	POLG_HCVED	INHIBITOR	EC50	12.52	DRUG LABEL	DRUG LABEL
Nonstructural protein 5A	Unclassified	Q5L478_9HEPC		EC50	10.70	CHEMBL

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External reference:

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ID	Source
016673	NDDF
1734628	RXNORM
31482	MMSL
4035373	VANDF
632L571YDK	UNII
716042006	SNOMEDCT_US
71661251	PUBCHEM_CID
816100007	SNOMEDCT_US
9851	INN_ID
C000589335	MESH_SUPPLEMENTAL_RECORD_UI

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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

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