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 9h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DOVATO is a fixed-dose combination tablet containing dolutegravir sodium and lamivudine, two nucleoside reverse transcriptase inhibitors (NRTIs) used to treat hepatitis B virus infection. The drug works by inhibiting reverse transcriptase, blocking viral replication and reducing HBV DNA levels. It represents a simplified two-drug regimen designed to improve adherence and treatment outcomes in HBV patients.
$0.433BPart D
PeakStable
4.2 years to LOEDOVATO is at peak commercial performance with $433M in Part D spending and 141K claims, indicating a mature, established franchise with stable team staffing focused on market optimization.
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.