velpatasvir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 6, 2016 | EMA | GILEAD SCIENCES IRELAND UC | |
| June 28, 2016 | FDA | GILEAD SCIENCES INC | |
| Jan. 8, 2019 | PMDA | Gilead Sciences K.K. |
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 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 | |
| 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 |
| 400MG;100MG;100MG | VOSEVI | GILEAD SCIENCES INC | N209195 | July 18, 2017 | RX | TABLET | ORAL | 9585906 | 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 | 9585906 | 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 |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | 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 | 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, 2023 | NEW STRENGTH |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | March 19, 2023 | NEW PATIENT POPULATION |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | May 15, 2023 | PEDIATRIC EXCLUSIVITY |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | July 14, 2023 | INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | July 14, 2023 | INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | Sept. 19, 2023 | PEDIATRIC EXCLUSIVITY |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | Sept. 19, 2023 | PEDIATRIC EXCLUSIVITY |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | Jan. 14, 2024 | PEDIATRIC EXCLUSIVITY |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | Jan. 14, 2024 | PEDIATRIC EXCLUSIVITY |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | April 27, 2025 | UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | April 27, 2025 | UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | April 27, 2025 | UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER |
| 200MG;50MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | April 27, 2025 | UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER |
| 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 | 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 | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | 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 |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | 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 | 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 |
| 200MG;50MG/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 |
| 200MG;50MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | March 19, 2020 | RX | TABLET | ORAL | Dec. 10, 2028 | PEDIATRIC EXCLUSIVITY |
| 400MG;100MG | EPCLUSA | GILEAD SCIENCES INC | N208341 | June 28, 2016 | RX | TABLET | ORAL | Dec. 10, 2028 | PEDIATRIC EXCLUSIVITY |
| 150MG;37.5MG/PACKET | EPCLUSA | GILEAD SCIENCES INC | N214187 | June 10, 2021 | RX | PELLETS | ORAL | Dec. 10, 2028 | PEDIATRIC EXCLUSIVITY |
| 200MG;50MG/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 |
| 11269 | IUPHAR_LIGAND_ID |
| 1799206 | RXNORM |
| 31777 | MMSL |
| d08455 | MMSL |
| 016909 | NDDF |
| 719641001 | SNOMEDCT_US |
| 816105002 | SNOMEDCT_US |
| C000604171 | MESH_SUPPLEMENTAL_RECORD_UI |
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 | 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 | 61958-2203 | 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 | 61958-2204 | PELLET | 50 mg | ORAL | NDA | 36 sections |
| Epclusa | HUMAN PRESCRIPTION DRUG LABEL | 2 | 61958-2205 | PELLET | 37.50 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 |
| Sofosbuvir and Velpatasvir | HUMAN PRESCRIPTION DRUG LABEL | 2 | 72626-2701 | TABLET, FILM COATED | 100 mg | ORAL | NDA AUTHORIZED GENERIC | 35 sections |