NDAORALTABLET
Approved
Apr 1955
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
5/8 — Partial
PLAQUENIL (hydroxychloroquine sulfate) by Hikma is 4-aminoquinoline antimalarial [see ] and antirheumatic agent. Approved for acute, chronic rheumatoid arthritis in adults, systemic lupus erythematosus in adults and 4 more indications. First approved in 1955.
Drug data last refreshed 10h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PLAQUENIL (hydroxychloroquine sulfate) is a 4-aminoquinoline oral antimalarial and antirheumatic agent approved in 1955. It treats rheumatoid arthritis, systemic lupus erythematosus, chronic discoid lupus erythematosus, and malaria via mechanisms that remain incompletely understood but involve anti-inflammatory and immunomodulatory effects. The drug is administered as an oral tablet for both acute and chronic indications.
$6.0MPart D
LOE ApproachingProduct is in LOE-approaching phase with modest Part D spending ($6M, 5,129 claims in 2023), indicating a mature, stable franchise with likely consolidation-focused commercial teams.
Mechanism of Action
4-aminoquinoline antimalarial [see ] and antirheumatic agent. Rheumatoid Arthritis, Systemic Lupus Erythematosus and Chronic Discoid Lupus Erythematosus The mechanisms underlying the anti-inflammatory and immunomodulatory effects of PLAQUENIL in the treatment of rheumatoid arthritis, chronic…
Indications (7)
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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.