NDAORALTABLETPriority Review
Approved
Apr 2019
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
2
Data completeness
7/8 — Comprehensive
Priority Review
DOVATO (dolutegravir sodium and lamivudine) by GSK is nucleoside reverse transcriptase inhibitors [moa]. Approved for hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc]. First approved in 2019.
Drug data last refreshed 2h ago · AI intelligence enriched 5h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DOVATO is a fixed-dose combination oral tablet containing dolutegravir sodium and lamivudine, approved in April 2019 for HIV treatment. It works by inhibiting reverse transcriptase enzymes that the virus uses to replicate. The combination provides a simplified, once-daily regimen for patients living with HIV.
$433MPart D
PeakStable
4.3 years to LOEDOVATO maintains peak market position with $433M in annual spending and strong claim volume; commercial teams are focused on defending market share against competitive consolidation.
Mechanism of Action
Nucleoside Reverse Transcriptase Inhibitors
Pharmacologic Class:
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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
Why This Matters for Your Career
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.