NDAORALTABLETPriority Review
Approved
Jun 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Mechanism of Action
Breast Cancer Resistance Protein Inhibitors
Pharmacologic Class:
Hepatitis C Virus NS5A Inhibitor
Clinical Trials (2)
Switch to Genvoya Followed by HCV Therapy With Epclusa Followed by Simplification of HIV Therapy With Biktarvy in Patients With HIV-HCV Co-Infected Subjects on Opioid Substitution Therapy
Started Feb 2018
25 enrolled
HIV-1-infectionHepatitis C, ChronicMethadone Dependence+6 more
Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
Started Jul 2014
106 enrolled
Hepatitis C Virus Infection
Loss of Exclusivity
LOE Date
Jul 30, 2034
102 months away
Patent Expiry
Jul 30, 2034
Exclusivity Expiry
Sep 19, 2027
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 8580765 | Mar 21, 2028 | SubstanceProduct | U-1470 |
| 9085573 | Mar 21, 2028 | SubstanceProduct | U-1470 |
| 8334270 | Mar 21, 2028 | SubstanceProduct | U-1470 |
| 8735372 | Mar 21, 2028 | U-1470 | |
| 8334270*PED | Sep 21, 2028 | — |