NDAORALTABLETPriority Review
Approved
Aug 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed Yesterday · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TIVICAY (dolutegravir sodium) is an oral integrase strand transfer inhibitor (INSTI) approved in 2013 for HIV treatment. It works by blocking HIV integrase, preventing viral DNA from integrating into human chromosomes. The drug is used across multiple HIV treatment regimens for both treatment-naïve and treatment-experienced patients.
$0.657BPart D
PeakStable
4.0 years to LOETIVICAY remains at peak lifecycle with $657M in Part D spending and 266,809 claims in 2023, indicating a substantial and stable commercial team.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
A Trial Evaluating Maintenance Therapy With Lamivudine (Epivir®) and Dolutegravir (Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple Highly Active Antiretroviral Therapy (HAART) (ANRS 167 Lamidol)
Started Sep 2015
110 enrolled
HIV-1 Infection
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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.