NDAORALTABLETPriority Review
Approved
Feb 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
11
Mechanism of Action
Nucleoside Reverse Transcriptase Inhibitors
Pharmacologic Class:
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Clinical Trials (5)
Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
Started Oct 2024
675 enrolled
HIV-1-infection
Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed
Started Aug 2024
675 enrolled
HIV-1-Infection
Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir
Started Apr 2024
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
Started Mar 2024
577 enrolled
HIV-1-infection
Effect of Biktarvy & Symtuza on microRNAs in HIV and Correlation With Weight Gain
Started Mar 2023
30 enrolled
HIV InfectionsObesity
Loss of Exclusivity
LOE Date
Nov 8, 2036
130 months away
Patent Expiry
Nov 8, 2036
Exclusivity Expiry
Feb 23, 2031
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 9296769 | Aug 15, 2032 | SubstanceProduct | U-257 |
| 8754065 | Aug 15, 2032 | SubstanceProduct | U-257 |
| 8754065*PED | Feb 15, 2033 | — | |
| 9296769*PED | Feb 15, 2033 | — | |
| 9732092 | Dec 19, 2033 | SubstanceProduct | — |