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velpatasvir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antivirals, hepatitis C Virus (HCV) NS5A inhibitors | 5154 | 1377049-84-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
pan-genotypic NS5A inhibitor for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection
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 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,EIF2AK3,GRK2,MAPK10,PDK1,PDK2,PDK4 | 7 | |||
| kinase-selectivity-class | PDK1 | 1 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 28, 2016 | FDA | GILEAD SCIENCES INC | |
| Jan. 8, 2019 | PMDA | Gilead Sciences K.K. | |
| July 6, 2016 | EMA | GILEAD SCIENCES IRELAND UC |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J05AP55 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections |
| ATC | J05AP56 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000998 | Antiviral Agents |
| 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 | N0000190109 | Organic Anion Transporting Polypeptide 2B1 Inhibitors |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| FDA EPC | N0000191256 | Hepatitis C Virus NS5A Inhibitor |
| CHEBI has role | CHEBI:36044 | antiviral drug |
| CHEBI has role | CHEBI:85185 | hepatitis C virus nonstructural protein 5A inhibitor |
Related Drugs by ATC class:
J05AP Antivirals for treatment of HCV infections 18 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chronic hepatitis C | indication | 128302006 | |
| Compensated cirrhosis | indication | 371139006 | |
| Decompensated cirrhosis of liver | indication | 716203000 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 11.48 | acidic |
| pKa2 | 12.26 | acidic |
| pKa3 | 12.93 | acidic |
| pKa4 | 13.17 | acidic |
| pKa5 | 6.49 | Basic |
| pKa6 | 5.8 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | 8334270 | March 21, 2028 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | 8580765 | March 21, 2028 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | 8735372 | March 21, 2028 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | 9085573 | March 21, 2028 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | 8334270 | March 21, 2028 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | 8580765 | March 21, 2028 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | 8735372 | March 21, 2028 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | 9085573 | March 21, 2028 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8334270 | March 21, 2028 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8334270 | March 21, 2028 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8580765 | March 21, 2028 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8580765 | March 21, 2028 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8735372 | March 21, 2028 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8735372 | March 21, 2028 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8957046 | March 21, 2028 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8957046 | March 21, 2028 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 9085573 | March 21, 2028 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 9085573 | March 21, 2028 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8334270 | March 21, 2028 | FOR THE TREATMENT OF HEPATITIS C |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8580765 | March 21, 2028 | FOR THE TREATMENT OF HEPATITIS C |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8735372 | March 21, 2028 | FOR THE TREATMENT OF HEPATITIS C |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 9085573 | March 21, 2028 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8334270 | March 21, 2028 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8580765 | March 21, 2028 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8735372 | March 21, 2028 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 9085573 | March 21, 2028 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | 7964580 | March 26, 2029 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | 8633309 | March 26, 2029 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | 8889159 | March 26, 2029 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | 7964580 | March 26, 2029 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | 8633309 | March 26, 2029 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | 8889159 | March 26, 2029 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 7964580 | March 26, 2029 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 7964580 | March 26, 2029 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8633309 | March 26, 2029 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8633309 | March 26, 2029 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8889159 | March 26, 2029 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8889159 | March 26, 2029 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 7964580 | March 26, 2029 | FOR THE TREATMENT OF HEPATITIS C |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8633309 | March 26, 2029 | FOR THE TREATMENT OF HEPATITIS C |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8889159 | March 26, 2029 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 7964580 | March 26, 2029 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8633309 | March 26, 2029 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8889159 | March 26, 2029 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | 9284342 | Sept. 13, 2030 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | 9284342 | Sept. 13, 2030 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 9284342 | Sept. 13, 2030 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 9284342 | Sept. 13, 2030 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 9284342 | Sept. 13, 2030 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 9284342 | Sept. 13, 2030 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | 8618076 | Dec. 11, 2030 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | 8618076 | Dec. 11, 2030 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8618076 | Dec. 11, 2030 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8618076 | Dec. 11, 2030 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8618076 | Dec. 11, 2030 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8618076 | Dec. 11, 2030 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | 8575135 | Nov. 16, 2032 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | 8921341 | Nov. 16, 2032 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | 8940718 | Nov. 16, 2032 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | 8575135 | Nov. 16, 2032 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | 8921341 | Nov. 16, 2032 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | 8940718 | Nov. 16, 2032 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8575135 | Nov. 16, 2032 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8575135 | Nov. 16, 2032 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8921341 | Nov. 16, 2032 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8921341 | Nov. 16, 2032 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8940718 | Nov. 16, 2032 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 8940718 | Nov. 16, 2032 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8575135 | Nov. 16, 2032 | FOR THE TREATMENT OF HEPATITIS C |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8921341 | Nov. 16, 2032 | FOR THE TREATMENT OF HEPATITIS C |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8940718 | Nov. 16, 2032 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8575135 | Nov. 16, 2032 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8921341 | Nov. 16, 2032 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 8940718 | Nov. 16, 2032 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | 10086011 | Jan. 30, 2034 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | 11116783 | Jan. 30, 2034 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | 10086011 | Jan. 30, 2034 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | 11116783 | Jan. 30, 2034 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 11116783 | Jan. 30, 2034 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 11116783 | Jan. 30, 2034 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 11116783 | Jan. 30, 2034 | FOR THE TREATMENT OF HEPATITIS C |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 11707479 | Jan. 30, 2034 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 11116783 | Jan. 30, 2034 | FOR THE TREATMENT OF HEPATITIS C |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | 11707479 | Jan. 30, 2034 | FOR THE TREATMENT OF HEPATITIS C |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 11338007 | June 1, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 11338007 | June 1, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | March 19, 2027 | TX OF PED PTS 6 YRS OF AGE & OLDER OR WEIGHING AT LEAST 17 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | March 19, 2027 | TX OF PED PTS 6 YRS OF AGE & OLDER OR WEIGHING AT LEAST 17 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | March 19, 2027 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | Sept. 19, 2027 | PEDIATRIC EXCLUSIVITY |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | Sept. 19, 2027 | PEDIATRIC EXCLUSIVITY |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | Sept. 19, 2027 | PEDIATRIC EXCLUSIVITY |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | June 10, 2028 | FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 6 YEARS OF AGE WEIGHING LESS THAN 17 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | Dec. 10, 2028 | PEDIATRIC EXCLUSIVITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Genome polyprotein | Polyprotein | INHIBITOR | EC50 | 11.10 | DRUG LABEL | DRUG LABEL | |||
| Genome polyprotein | Polyprotein | INHIBITOR | EC50 | 10.80 | DRUG LABEL | DRUG LABEL | |||
| Genome polyprotein | Polyprotein | INHIBITOR | EC50 | 10.85 | DRUG LABEL | DRUG LABEL | |||
| Genome polyprotein | Polyprotein | INHIBITOR | EC50 | 10.98 | DRUG LABEL | DRUG LABEL | |||
| Genome polyprotein | Polyprotein | INHIBITOR | EC50 | 11.05 | DRUG LABEL | DRUG LABEL | |||
| Genome polyprotein | Polyprotein | INHIBITOR | EC50 | 11.40 | DRUG LABEL | DRUG LABEL | |||
| Genome polyprotein | Polyprotein | INHIBITOR | EC50 | 11.40 | DRUG LABEL | DRUG LABEL | |||
| Genome polyprotein | Polyprotein | INHIBITOR | EC50 | 10.43 | DRUG LABEL | DRUG LABEL | |||
| Nonstructural protein 5A | Unclassified | EC50 | 11 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| KCU0C7RS7Z | UNII |
| 4035867 | VANDF |
| C4079582 | UMLSCUI |
| CHEBI:133009 | CHEBI |
| CHEMBL3545062 | ChEMBL_ID |
| 67683363 | PUBCHEM_CID |
| DB11613 | DRUGBANK_ID |
| 9960 | INN_ID |
| C000604171 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11269 | IUPHAR_LIGAND_ID |
| 1799206 | RXNORM |
| 31777 | MMSL |
| d08455 | MMSL |
| 719641001 | SNOMEDCT_US |
| 816105002 | SNOMEDCT_US |
| 016909 | NDDF |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Epclusa | HUMAN PRESCRIPTION DRUG LABEL | 2 | 61958-2201 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 36 sections |
| Epclusa Access | HUMAN PRESCRIPTION DRUG LABEL | 2 | 61958-2202 | TABLET, FILM COATED | 100 mg | ORAL | Export only | 31 sections |
| Epclusa | HUMAN PRESCRIPTION DRUG LABEL | 2 | 61958-2203 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 36 sections |
| Epclusa | HUMAN PRESCRIPTION DRUG LABEL | 2 | 61958-2204 | PELLET | 50 mg | ORAL | NDA | 36 sections |
| Epclusa | HUMAN PRESCRIPTION DRUG LABEL | 2 | 61958-2205 | PELLET | 37.50 mg | ORAL | NDA | 36 sections |
| Vosevi | HUMAN PRESCRIPTION DRUG LABEL | 3 | 61958-2401 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 34 sections |
| Sofosbuvir and Velpatasvir | HUMAN PRESCRIPTION DRUG LABEL | 2 | 72626-2701 | TABLET, FILM COATED | 100 mg | ORAL | NDA AUTHORIZED GENERIC | 35 sections |