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

Stem definitionDrug idCAS RN
Hepatitis Virus C (HVC) protease inhibitors 4913 1216941-48-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • paritaprevir dihydrate
  • paritaprevir
  • veruprevir
  • ABT-450
  • paritapravir
inhibits HCV NS3 protease
  • Molecular weight: 765.89
  • Formula: C40H43N7O7S
  • CLOGP: 6.28
  • LIPINSKI: 3
  • HAC: 14
  • HDO: 3
  • TPSA: 189.65
  • ALOGS: -4.99
  • ROTB: 6

  • Status: ONP

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

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution) 1.37 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.74 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.02 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 8.71 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 20, 2014 EMA
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 MoA N0000182638 HCV NS3/4A Protease Inhibitors
FDA EPC N0000182639 Hepatitis C Virus NS3/4A Protease Inhibitor
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 N0000191272 UGT1A1 Inhibitors
FDA MoA N0000185503 P-Glycoprotein 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 4.23 acidic
pKa2 13.41 acidic
pKa3 3.65 Basic
pKa4 3.01 Basic
pKa5 0.2 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.
50MG 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
50MG 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.
50MG 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
75MG TECHNIVIE ABBVIE INC N207931 July 24, 2015 DISCN TABLET ORAL 8642538 Sept. 10, 2029 TREATMENT OF HCV INFECTION USING PARITAPREVIR
50MG 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
75MG TECHNIVIE ABBVIE INC N207931 July 24, 2015 DISCN TABLET ORAL 9006387 June 10, 2030 TREATMENT OF HCV INFECTION USING OMBITASVIR
50MG 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
75MG TECHNIVIE ABBVIE INC N207931 July 24, 2015 DISCN TABLET ORAL 9044480 April 10, 2031 TREATMENT OF HCV INFECTION USING PARITAPREVIR
50MG VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 9044480 April 10, 2031 TREATMENT OF HCV INFECTION USING PARITAPREVIR
50MG 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
50MG 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.
50MG 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
50MG 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.
50MG 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
50MG 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
50MG 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
50MG 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:

None

External reference:

IDSource
D10580 KEGG_DRUG
C3883274 UMLSCUI
HRQ5901O78 UNII
1456607-71-8 SECONDARY_CAS_RN
9739 INN_ID
DB09297 DRUGBANK_ID
CHEBI:85188 CHEBI
CHEMBL3391662 ChEMBL_ID
45110509 PUBCHEM_CID
C585405 MESH_SUPPLEMENTAL_RECORD_UI
714428008 SNOMEDCT_US
1597373 RXNORM
015826 NDDF
4034027 VANDF
30777 MMSL
d08321 MMSL
714420001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Viekira Pak HUMAN PRESCRIPTION DRUG LABEL 4 0074-3093 KIT 75 mg None NDA 19 sections