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 13h ago · AI intelligence enriched 15h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TIVICAY (dolutegravir sodium) is an oral integrase strand transfer inhibitor (INSTI) approved in 2013 for HIV-1 treatment. It works by blocking integrase, an HIV enzyme required for viral replication, preventing the virus from incorporating its genetic material into human DNA. The drug is indicated for HIV-1 infection in treatment-naive and treatment-experienced patients.
$0.657BPart D
Peak3.7 years to LOETIVICAY remains at peak commercial performance with $657M in 2023 Part D spending and strong claim volume, supporting substantial brand and market access teams despite approaching patent expiration.
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.