TIVICAY
PeakNDAORALTABLETPriority Review
Approved
Aug 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 2h 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 enzyme integrase, preventing viral DNA from integrating into host cell chromosomes. The drug is indicated for treatment-naive and treatment-experienced adults with HIV-1 infection.
$657MPart D
Peak3.6 years to LOEPeak-stage product with strong Part D spending reflects established market position; brand teams are focused on lifecycle extension and market defense against competitive pressure (8/10).
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.