NDAORALTABLETPriority Review
Approved
Nov 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
JULUCA is a fixed-dose combination tablet containing dolutegravir sodium (an integrase strand transfer inhibitor) and rilpivirine hydrochloride (a non-nucleoside reverse transcriptase inhibitor) for the treatment of HIV-1 infection. It is indicated as a complete regimen for HIV-1 infected patients to replace their current antiretroviral regimen in those who are virologically suppressed. This oral small-molecule combination offers a simplified two-drug maintenance therapy for stable HIV patients.
$392MPart D
Peak12.1 years to LOEJULUCA is at peak commercial stage with $392M in annual Part D spending, indicating a mature, stable revenue base that supports established commercial teams and focused sales efforts.
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)
Study to Evaluate Pharmacokinetics, Safety and Tolerability of Dolutegravir and Rilpivirine (JULUCA™) 50 Milligram (mg)/25 mg Tablets in Healthy Subjects of Japanese Descent
Started Jun 2019
16 enrolled
HIV Infections
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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.