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 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PREZCOBIX is a fixed-dose combination oral tablet containing darunavir ethanolate and cobicistat, approved in 2015 for HIV treatment. It functions as a cytochrome P450 3A inhibitor, enhancing the pharmacokinetic profile of darunavir to improve antiretroviral efficacy. The drug is indicated for use in HIV-infected patients as part of combination antiretroviral therapy.
$0.272BPart D
PeakStable
6.3 years to LOEPREZCOBIX maintains peak revenue with $272M in Part D spending (2023) but faces moderate competitive pressure from newer fixed-dose combinations, suggesting stable but not expanding team needs.
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.