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 21h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PLAQUENIL (hydroxychloroquine sulfate) is a 4-aminoquinoline oral tablet approved in 1955 for treating rheumatoid arthritis, systemic lupus erythematosus, discoid lupus erythematosus, and malaria. The exact anti-inflammatory and immunomodulatory mechanisms remain incompletely understood, though it is believed to work through multiple pathways affecting immune cell function.
$6MPart D
LOE ApproachingStable
Product is approaching loss of exclusivity with limited spending (~$6M Part D annually); brand team likely focused on transition planning and defending market position against generics.
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.