paritaprevir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| Hepatitis Virus C (HVC) protease inhibitors | 4913 | 1216941-48-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
inhibits HCV NS3 protease
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 20, 2014 | EMA | ||
| 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 | 81.41 | 71.75 | 38 | 246 | 225908 | 34730739 |
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 | 131.25 | 64.56 | 55 | 342 | 415128 | 79328863 |
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 MoA | N0000182638 | HCV NS3/4A Protease Inhibitors |
| FDA EPC | N0000182639 | Hepatitis C Virus NS3/4A Protease Inhibitor |
| 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 | N0000191272 | UGT1A1 Inhibitors |
| CHEBI has role | CHEBI:36044 | antiviral drugs |
| CHEBI has role | CHEBI:64924 | hepatitis C protease 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 | 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 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 250MG BASE;12.5MG, 75MG, 50MG | VIEKIRA PAK (COPACKAGED) | ABBVIE | N206619 | Dec. 19, 2014 | DISCN | TABLET | 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 | 9139536 | Nov. 9, 2028 | TREATMENT OF HCV INFECTION USING DASABUVIR |
| EQ 250MG BASE;12.5MG, 75MG, 50MG | VIEKIRA PAK (COPACKAGED) | ABBVIE | N206619 | Dec. 19, 2014 | DISCN | TABLET | ORAL | 8501238 | Dec. 19, 2028 | USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION. |
| EQ 250MG BASE;12.5MG, 75MG, 50MG | VIEKIRA PAK (COPACKAGED) | ABBVIE | N206619 | Dec. 19, 2014 | DISCN | TABLET | ORAL | 8188104 | May 17, 2029 | 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 | 8188104 | May 17, 2029 | USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION. |
| EQ 250MG BASE;12.5MG, 75MG, 50MG | VIEKIRA PAK (COPACKAGED) | ABBVIE | N206619 | Dec. 19, 2014 | DISCN | TABLET | 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 | 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 |
| EQ 250MG BASE;12.5MG, 75MG, 50MG | VIEKIRA PAK (COPACKAGED) | ABBVIE | N206619 | Dec. 19, 2014 | DISCN | TABLET | 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 | 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 |
| EQ 250MG BASE;12.5MG, 75MG, 50MG | VIEKIRA PAK (COPACKAGED) | ABBVIE | N206619 | Dec. 19, 2014 | DISCN | TABLET | ORAL | 9044480 | April 10, 2031 | 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 | 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 250MG BASE;12.5MG, 75MG, 50MG | VIEKIRA PAK (COPACKAGED) | ABBVIE | N206619 | Dec. 19, 2014 | DISCN | TABLET | ORAL | 8466159 | Sept. 4, 2032 | TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN. |
| EQ 250MG BASE;12.5MG, 75MG, 50MG | VIEKIRA PAK (COPACKAGED) | ABBVIE | N206619 | Dec. 19, 2014 | DISCN | TABLET | ORAL | 8492386 | Sept. 4, 2032 | TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN |
| EQ 250MG BASE;12.5MG, 75MG, 50MG | VIEKIRA PAK (COPACKAGED) | ABBVIE | N206619 | Dec. 19, 2014 | DISCN | TABLET | ORAL | 8680106 | Sept. 4, 2032 | TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN. |
| EQ 250MG BASE;12.5MG, 75MG, 50MG | VIEKIRA PAK (COPACKAGED) | ABBVIE | N206619 | Dec. 19, 2014 | DISCN | TABLET | 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 | 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 250MG BASE;12.5MG, 75MG, 50MG | VIEKIRA PAK (COPACKAGED) | ABBVIE | N206619 | Dec. 19, 2014 | DISCN | TABLET | ORAL | 10201542 | Oct. 18, 2033 | TREATMENT OF HCV INFECTION USING DASABUVIR |
| EQ 250MG BASE;12.5MG, 75MG, 50MG | VIEKIRA PAK (COPACKAGED) | ABBVIE | N206619 | Dec. 19, 2014 | DISCN | TABLET | ORAL | 9629841 | Oct. 18, 2033 | 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 | 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:
None
External reference:
| ID | Source |
|---|---|
| D10580 | KEGG_DRUG |
| 1456607-71-8 | SECONDARY_CAS_RN |
| 4034027 | VANDF |
| CHEBI:85188 | CHEBI |
| CHEMBL3391662 | ChEMBL_ID |
| C585405 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11273 | IUPHAR_LIGAND_ID |
| DB09297 | DRUGBANK_ID |
| 1597373 | RXNORM |
| 30777 | MMSL |
| d08321 | MMSL |
| 015826 | NDDF |
| 714420001 | SNOMEDCT_US |
| 714428008 | SNOMEDCT_US |
| C3864824 | UMLSCUI |
| 9739 | INN_ID |
| 45110509 | PUBCHEM_CID |
| OU2YM37K86 | UNII |
Pharmaceutical products:
None