NDAORALTABLETPriority Review
Approved
Mar 2016
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
5/8 — Partial
Priority Review
ODEFSEY (emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide) by Gilead Sciences is nucleoside reverse transcriptase inhibitors [moa]. Approved for human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]. First approved in 2016.
Drug data last refreshed 8h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ODEFSEY is a fixed-dose combination tablet containing emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide for oral treatment of HIV-1 infection. It works by inhibiting reverse transcriptase, a key enzyme HIV uses to replicate. The combination targets treatment-naïve and virologically suppressed adult patients seeking a simplified, once-daily regimen.
$384MPart D
PeakStable
6.5 years to LOEODEFSEY is in peak commercial phase with $384M in Part D spending, indicating an established, mature portfolio requiring focused defensive strategies against superior competitors and upcoming LOE.
Mechanism of Action
Nucleoside Reverse Transcriptase Inhibitors
Pharmacologic Class:
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Why This Matters for Your Career
$384M Medicare spend — this is a commercially significant brand
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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.