NDAORALSUSPENSIONPriority Review
Approved
Dec 2011
Lifecycle
LOE Approaching
Competitive Pressure
40/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 49m ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PREZISTA (darunavir) is an oral protease inhibitor suspension approved for HIV treatment. It works by inhibiting HIV protease, preventing viral replication in infected patients. The suspension formulation enables dosing flexibility, particularly for pediatric and patients with swallowing difficulties.
$0.133BPart D
LOE ApproachingStable
9mo to LOEWith only 0.8 years until LOE, the brand team is in transition planning mode; expect focus on lifecycle extension strategies and reduced hiring for growth initiatives.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children
Started Aug 2022
15 enrolled
Human Immunodeficiency Virus (HIV)
A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Compared to the Co-administration of the Separate Available Formulations of Darunavir and Cobicistat Under Fed Conditions in Healthy Participants
Started Jun 2022
32 enrolled
Healthy
A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions
Started Jan 2021
22 enrolled
Healthy
A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents
Started Jan 2021
37 enrolled
Healthy
Drug-drug Interaction (DDI) Study of GSK3640254 With Darunavir/Ritonavir (DRV/RTV) and Etravirine (ETR)
Started Oct 2020
54 enrolled
HIV Infections
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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.