SOVALDI

Peak

sofosbuvir

NDAORALPELLETSPriority Review
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
67

Mechanism of Action

RNA Replicase Inhibitors

Pharmacologic Class:

Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor

Clinical Trials (5)

NCT05140941Phase 4Recruiting

Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy

Started Apr 2022
100 enrolled
Hepatitis C, ChronicPregnancy; Infection
NCT04382404Phase 1Completed

Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

Started Oct 2020
11 enrolled
Hepatitis C, Chronic
NCT03987503Phase 4Completed

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

Started Jul 2020
87 enrolled
Hepatitis C, Chronic
NCT04211909Phase 3Completed

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
NCT04112303Phase 3Completed

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

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 #ExpiryTypeUse Code
9085573
Mar 21, 2028
SubstanceProduct
U-1470
8334270
Mar 21, 2028
SubstanceProduct
U-1470
8580765
Mar 21, 2028
SubstanceProduct
U-1470
9085573*PED
Sep 21, 2028
8334270*PED
Sep 21, 2028