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

Stem definition	Drug id	CAS RN
antivirals, hepatitis C Virus (HCV) NS5A inhibitors	4912	1258226-87-7

Description:

Molecule

Description

Molfile Inchi Smiles

Synonyms:

ombitasvir hydrate
ombitasvir heminonahydrate
ombitasvir
ABT-267

inhibits HCV NS5A protein

Molecular weight: 894.13
Formula: C50H67N7O8
CLOGP: 8.39
LIPINSKI: 3
HAC: 15
HDO: 4
TPSA: 178.72
ALOGS: -5.67
ROTB: 16

Status: OFM

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	Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution)	2.32 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.68 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.00 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	28.49 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Nov. 20, 2014	EMA	AbbVie Ltd
Dec. 19, 2014	FDA	ABBVIE INC

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

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
Drug interaction	98.11	48.66	46	301	225900	34730684

FDA Adverse Event Reporting System (Geriatric)

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
Drug interaction	147.37	54.57	66	487	415117	79328718
Drug level increased	57.83	54.57	18	535	39633	79704202
Hyperbilirubinaemia	57.11	54.57	16	537	24502	79719333

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	J05AP52	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections
ATC	J05AP53	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	N0000191272	UGT1A1 Inhibitors
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|

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

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.81	acidic
pKa2	4.5	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	8501238	Sept. 17, 2028	USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	9139536	Nov. 9, 2028	TREATMENT OF HCV INFECTION USING DASABUVIR
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	8188104	May 17, 2029	USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
12.5MG;75MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TECHNIVIE	ABBVIE	N207931	July 24, 2015	DISCN	TABLET	ORAL	8642538	Sept. 10, 2029	TREATMENT OF HCV INFECTION USING PARITAPREVIR
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	8642538	Sept. 10, 2029	TREATMENT OF HCV INFECTION USING PARITAPREVIR
12.5MG;75MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TECHNIVIE	ABBVIE	N207931	July 24, 2015	DISCN	TABLET	ORAL	9006387	June 10, 2030	TREATMENT OF HCV INFECTION USING OMBITASVIR
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	9006387	June 10, 2030	TREATMENT OF HCV INFECTION USING OMBITASVIR
12.5MG;75MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TECHNIVIE	ABBVIE	N207931	July 24, 2015	DISCN	TABLET	ORAL	9044480	April 10, 2031	TREATMENT OF HCV INFECTION USING PARITAPREVIR
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	9044480	April 10, 2031	TREATMENT OF HCV INFECTION USING PARITAPREVIR
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	10201584	May 17, 2032	TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	8466159	Sept. 4, 2032	TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN.
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	8492386	Sept. 4, 2032	TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	8680106	Sept. 4, 2032	TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN.
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	8685984	Sept. 4, 2032	TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	10105365	Jan. 2, 2035	TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	9333204	Jan. 2, 2035	TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	9744170	Jan. 2, 2035	TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Genome polyprotein	Polyprotein		POLG_HCVBK	INHIBITOR	EC50	11.30		SCIENTIFIC LITERATURE	DRUG LABEL
Genome polyprotein	Polyprotein		POLG_HCVH	INHIBITOR	EC50	10.85		SCIENTIFIC LITERATURE	DRUG LABEL
Nonstructural protein 5A	Unclassified		Q5L478_9HEPC		EC50	10.85		CHEMBL
Genome polyprotein [Cleaved into: Core protein p21	Unclassified		POLG_HCVCO		EC50	10.92		CHEMBL

External reference:

ID	Source
D10576	KEGG_DRUG
1456607-70-7	SECONDARY_CAS_RN
4034026	VANDF
CHEBI:85183	CHEBI
CHEMBL3127326	ChEMBL_ID
C586094	MESH_SUPPLEMENTAL_RECORD_UI
11272	IUPHAR_LIGAND_ID
DB09296	DRUGBANK_ID
1597371	RXNORM
30776	MMSL
d08320	MMSL
015825	NDDF
713479007	SNOMEDCT_US
714429000	SNOMEDCT_US
C3852670	UMLSCUI
9740	INN_ID
54767916	PUBCHEM_CID
2302768XJ8	UNII

Pharmaceutical products:

None