NDAORALTABLETPriority Review
Approved
Apr 2019
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
2
Mechanism of Action
Nucleoside Reverse Transcriptase Inhibitors
Pharmacologic Class:
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Clinical Trials (2)
Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)
Started Sep 2021
40 enrolled
Human Immunodeficiency Virus
A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants
Started May 2021
33 enrolled
HIV Infections
Loss of Exclusivity
LOE Date
Jan 24, 2031
59 months away
Patent Expiry
Jan 24, 2031
Exclusivity Expiry
Apr 5, 2027
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 8129385 | Oct 5, 2027 | SubstanceProduct | — |
| 8129385*PED | Apr 5, 2028 | — | |
| 9242986 | Dec 8, 2029 | SubstanceProduct | — |
| 9242986*PED | Jun 8, 2030 | — | |
| 11234985 | Jan 24, 2031 | Product | U-257 |