NDAORALTABLETPriority Review
Approved
Mar 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
6/8 — Strong
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 19h 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, approved by the FDA in March 2016. It is indicated for the treatment of human immunodeficiency virus (HIV) infection in treatment-naïve adults. The product works through nucleoside reverse transcriptase inhibition, blocking viral replication at the reverse transcriptase enzyme level. ODEFSEY represents an alternative integrase-sparing regimen in the modern HIV treatment landscape, offering convenience through single-tablet dosing.
$0.4BPart D
6.8 years to LOEMechanism 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.
Clinical Trials (1)
Tenofovir/Emtricitabine for PMTCT in Africa and Asia (ANRS 12109 TEmAA)
Started Oct 2006
72 enrolled
HIV InfectionPregnancy
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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.