NDAORALTABLETPriority Review
Approved
Dec 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
21
Mechanism of Action
RNA Replicase Inhibitors
Pharmacologic Class:
Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Clinical Trials (5)
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Started Apr 2022
100 enrolled
Hepatitis C, ChronicPregnancy; Infection
Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir
Started Oct 2020
11 enrolled
Hepatitis C, Chronic
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
Started Jan 2020
87 enrolled
Hepatitis C Virus Infection
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
Started Oct 2019
37 enrolled
Hepatitis C Virus Infection
Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir
Started May 2019
20 enrolled
Hepatitis CAcute Hepatitis C
Loss of Exclusivity
LOE Date
Jun 11, 2031
64 months away
Patent Expiry
Jun 11, 2031
Exclusivity Expiry
Aug 28, 2026
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 9085573 | Mar 21, 2028 | SubstanceProduct | U-1470 |
| 8580765 | Mar 21, 2028 | SubstanceProduct | U-1470 |
| 8334270 | Mar 21, 2028 | SubstanceProduct | U-1470 |
| 8580765*PED | Sep 21, 2028 | — | |
| 8334270*PED | Sep 21, 2028 | — |