NDAORALTABLET
Approved
Apr 1955
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
PLAQUENIL (hydroxychloroquine sulfate) by Hikma is 4-aminoquinoline antimalarial [see ] and antirheumatic agent. First approved in 1955.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PLAQUENIL (hydroxychloroquine sulfate) is an oral 4-aminoquinoline antimalarial and antirheumatic agent approved in 1955 for rheumatoid arthritis, systemic lupus erythematosus, discoid lupus erythematosus, and malaria. The exact mechanisms of its anti-inflammatory and immunomodulatory effects remain incompletely understood, though it modulates immune response across multiple pathways. It represents a foundational, long-established therapy in rheumatology with broad clinical utility.
$6MPart D
LOE ApproachingDeclining
As LOE approaches, commercial teams face declining spending and margin pressure; focus shifts to generic transition planning and niche market retention rather than growth.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy
Started Jun 2016
98 enrolled
Primary IgA Nephropathy
Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion
Started Mar 2012
103 enrolled
Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus
To Demonstrate the Relative Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets
Started Jul 1993
72 enrolled
ImmunosuppressionRheumatism
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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.