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 17h 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 the treatment of HIV-1 infection. It combines nucleoside and non-nucleoside reverse transcriptase inhibitors to suppress viral replication. The three-in-one formulation simplifies dosing for treatment-experienced and treatment-naive adults with HIV.
$0.384BPart D
Peak6.3 years to LOEProduct is in peak revenue phase with $384M in Part D spending; commercial team likely stable and focused on market maintenance rather than growth expansion.
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.