PREZCOBIX
LaunchNDAORALTABLET, FOR SUSPENSION
Approved
Feb 2026
Lifecycle
Launch
Competitive Pressure
30/100
Data completeness
3/8 — Basic
PREZCOBIX by Johnson & Johnson is fixed-dose combinations of an hiv-1 antiviral drug, darunavir and a cyp3a inhibitor, cobicistat [see ]. Approved for hiv-1 in treatment-naïve, treatment-experienced adults, older weighing at least 15 kg with no darunavir resistance-associated substitutions (v11i and 10 more indications. First approved in 2026.
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PREZCOBIX is a fixed-dose combination tablet containing darunavir (HIV-1 protease inhibitor) and cobicistat (CYP3A inhibitor) for oral administration. It treats HIV-1 infection in treatment-naïve and treatment-experienced adults and children weighing at least 15 kg without darunavir resistance mutations. The cobicistat component enhances darunavir bioavailability by inhibiting CYP3A metabolism.
Growth
Recent 2026 approval positions the brand in early growth phase with moderate competitive pressure; commercial teams will focus on market penetration and physician education in HIV treatment.
Mechanism of Action
fixed-dose combinations of an HIV-1 antiviral drug, darunavir and a CYP3A inhibitor, cobicistat [see ].
Indications (13)
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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.