NDAORALCAPSULE
Approved
Aug 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
QUALAQUIN (quinine sulfate) by PharmaIN is 12. First approved in 2005.
Drug data last refreshed 8h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
QUALAQUIN (quinine sulfate) is an oral antimalarial agent approved for treating uncomplicated P. falciparum malaria. It works by mechanisms consistent with antimalarial activity, though the exact pharmacodynamic basis is not fully detailed in the provided data. The drug is administered orally in capsule form with a mean half-life of approximately 10–12 hours in healthy subjects.
LOE Approaching
Product is approaching loss of exclusivity with limited commercial momentum, suggesting a smaller brand team focused on defending market share rather than growth initiatives.
Mechanism of Action
12.1 Mechanism of Action Quinine is an antimalarial agent [ see ]. 12.2 Pharmacodynamics QTc interval prolongation was studied in a double-blind, multiple dose, placebo- and positive-controlled crossover study in young (N=13, 20 to 39 years) and elderly (N=13, 65 to 78 years) subjects. After 7 days…
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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.