NDAORALTABLETPriority Review
Approved
Jan 2015
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
5/8 — Partial
Priority Review
PREZCOBIX (darunavir ethanolate and cobicistat) by Johnson & Johnson is cytochrome p450 3a inhibitors [moa]. Approved for cytochrome p450 3a inhibitor [epc]. First approved in 2015.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PREZCOBIX is a fixed-dose oral tablet combining darunavir ethanolate (protease inhibitor) and cobicistat (CYP3A inhibitor) approved in 2015 for HIV treatment. It works by inhibiting cytochrome P450 3A enzymes to boost darunavir exposure and viral suppression. The combination therapy represents a convenient single-tablet regimen for treatment-experienced HIV patients.
$272MPart D
PeakStable
6.0 years to LOEProduct is in peak revenue phase with $272M annual Part D spending and 103K claims, indicating sustained commercial teams supporting a mature, stable franchise.
Mechanism of Action
Cytochrome P450 3A Inhibitors
Pharmacologic Class:
Cytochrome P450 3A 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
$272M 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.