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

Stem definitionDrug idCAS RN
antivirals, hepatitis C Virus (HCV) NS5A inhibitors 4912 1258226-87-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ombitasvir hydrate
  • ombitasvir heminonahydrate
  • ombitasvir
  • ABT-267
inhibits HCV NS5A protein
  • Molecular weight: 894.13
  • Formula: C50H67N7O8
  • CLOGP: 8.03
  • LIPINSKI: 3
  • HAC: 15
  • HDO: 4
  • TPSA: 178.72
  • ALOGS: -5.67
  • ROTB: 16

  • 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 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:

DateAgencyCompanyOrphan
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)

None

Pharmacologic Action:

SourceCodeDescription
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
CHEBI has role CHEBI:36044 antiviral drug
FDA EPC N0000191256 Hepatitis C Virus NS5A Inhibitor
FDA MoA N0000191272 UGT1A1 Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Chronic hepatitis C indication 128302006

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.81 acidic
pKa2 4.5 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
None VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 RX TABLET, TABLET ORAL 8501238 Sept. 17, 2028 USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
8.33MG VIEKIRA XR ABBVIE INC 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.
None VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 RX TABLET, TABLET ORAL 9139536 Nov. 9, 2028 TREATMENT OF HCV INFECTION USING DASABUVIR
8.33MG VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 9139536 Nov. 9, 2028 TREATMENT OF HCV INFECTION USING DASABUVIR
None VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 RX TABLET, TABLET ORAL 8188104 May 17, 2029 USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
8.33MG VIEKIRA XR ABBVIE INC 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.
None VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 RX TABLET, TABLET ORAL 8642538 Sept. 10, 2029 TREATMENT OF HCV INFECTION USING PARITAPREVIR
12.5MG TECHNIVIE ABBVIE INC N207931 July 24, 2015 DISCN TABLET ORAL 8642538 Sept. 10, 2029 TREATMENT OF HCV INFECTION USING PARITAPREVIR
8.33MG VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 8642538 Sept. 10, 2029 TREATMENT OF HCV INFECTION USING PARITAPREVIR
None VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 RX TABLET, TABLET ORAL 9006387 June 10, 2030 TREATMENT OF HCV INFECTION USING OMBITASVIR
12.5MG TECHNIVIE ABBVIE INC N207931 July 24, 2015 DISCN TABLET ORAL 9006387 June 10, 2030 TREATMENT OF HCV INFECTION USING OMBITASVIR
8.33MG VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 9006387 June 10, 2030 TREATMENT OF HCV INFECTION USING OMBITASVIR
None VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 RX TABLET, TABLET ORAL 9044480 April 10, 2031 TREATMENT OF HCV INFECTION USING PARITAPREVIR
12.5MG TECHNIVIE ABBVIE INC N207931 July 24, 2015 DISCN TABLET ORAL 9044480 April 10, 2031 TREATMENT OF HCV INFECTION USING PARITAPREVIR
8.33MG VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 9044480 April 10, 2031 TREATMENT OF HCV INFECTION USING PARITAPREVIR
8.33MG VIEKIRA XR ABBVIE INC 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
None VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 RX TABLET, TABLET ORAL 8466159 Sept. 4, 2032 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN.
None VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 RX TABLET, TABLET ORAL 8492386 Sept. 4, 2032 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN
None VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 RX TABLET, TABLET ORAL 8680106 Sept. 4, 2032 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN.
None VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 RX TABLET, TABLET ORAL 8685984 Sept. 4, 2032 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN
8.33MG VIEKIRA XR ABBVIE INC 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.
8.33MG VIEKIRA XR ABBVIE INC 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
8.33MG VIEKIRA XR ABBVIE INC 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.
8.33MG VIEKIRA XR ABBVIE INC 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
None VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 RX TABLET, TABLET ORAL 10201542 Oct. 18, 2033 TREATMENT OF HCV INFECTION USING DASABUVIR
None VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 RX TABLET, TABLET ORAL 9629841 Oct. 18, 2033 TREATMENT OF HCV INFECTION USING DASABUVIR
8.33MG VIEKIRA XR ABBVIE INC 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
8.33MG VIEKIRA XR ABBVIE INC 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
8.33MG VIEKIRA XR ABBVIE INC 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Genome polyprotein Polyprotein INHIBITOR EC50 10.85 SCIENTIFIC LITERATURE DRUG LABEL
Genome polyprotein Polyprotein INHIBITOR EC50 11.30 SCIENTIFIC LITERATURE DRUG LABEL

External reference:

IDSource
D10576 KEGG_DRUG
C3883273 UMLSCUI
2302768XJ8 UNII
9740 INN_ID
714429000 SNOMEDCT_US
1597371 RXNORM
015825 NDDF
4034026 VANDF
30776 MMSL
d08320 MMSL
713479007 SNOMEDCT_US
54767916 PUBCHEM_CID
CHEBI:85183 CHEBI
1456607-70-7 SECONDARY_CAS_RN
DB09296 DRUGBANK_ID
C586094 MESH_SUPPLEMENTAL_RECORD_UI
CHEMBL3127326 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Viekira Pak HUMAN PRESCRIPTION DRUG LABEL 4 0074-3093 KIT 12.50 mg None NDA 19 sections