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 10h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TIVICAY (dolutegravir sodium) is an oral integrase strand transfer inhibitor (INSTI) approved for HIV-1 treatment. It works by blocking the HIV integrase enzyme, preventing viral DNA from integrating into human host cell DNA. The drug is indicated for treatment-naive and treatment-experienced HIV-1 patients.
$0.657BPart D
PeakStable
3.8 years to LOEPeak-stage asset with $657M in Part D spending (2023) and high claim volume suggests a stable, mature brand team with focus on market maintenance and optimization.
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
Why This Matters for Your Career
Worked on TIVICAY at GSK? Share your interview experience or compensation data (+7 days Pro)
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.