NDAORALPELLETSPriority Review
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6
Mechanism of Action
RNA Replicase Inhibitors
Pharmacologic Class:
Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Clinical Trials (5)
Harvoni Treatment Porphyria Cutanea Tarda
Started Sep 2017
23 enrolled
Porphyria Cutanea TardaHepatitis C
Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
Started Dec 2016
1,081 enrolled
Hepatitis C Virus
Evaluation of HepCure Toolkit to Improve Harvoni Adherence
Started Feb 2016
71 enrolled
Hepatitis CMedication Adherence
Effects of Harvoni in Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection
Started Jan 2016
14 enrolled
Hepatitis C, ChronicCirrhosis, Decompensated
Use-Results Surveillance Study of Harvoni® in Japanese Patients With Chronic Genotype 1 Hepatitis C Virus Infection
Started Nov 2015
3,294 enrolled
Hepatitis C
Loss of Exclusivity
LOE Date
Mar 14, 2033
85 months away
Patent Expiry
Mar 14, 2033
Exclusivity Expiry
Aug 28, 2026
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 8580765 | Mar 21, 2028 | SubstanceProduct | U-1470 |
| 8735372 | Mar 21, 2028 | U-1470 | |
| 9085573 | Mar 21, 2028 | SubstanceProduct | U-1470 |
| 8334270 | Mar 21, 2028 | SubstanceProduct | U-1470 |
| 9085573*PED | Sep 21, 2028 | — |