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 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PREZCOBIX is an oral tablet combining darunavir ethanolate and cobicistat, two cytochrome P450 3A inhibitors approved by the FDA on January 29, 2015. The product is indicated for use as a boosted protease inhibitor in HIV treatment regimens. Cobicistat acts as a pharmacokinetic booster, enhancing darunavir exposure and allowing for simplified dosing in combination antiretroviral therapy. PREZCOBIX positions itself as a foundational component in modern HIV treatment, typically used as part of multi-drug regimens rather than as monotherapy.
$0.3BPart D
6.4 years to LOEMechanism 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.