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 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
QUALAQUIN (quinine sulfate) is an oral antimalarial agent used to treat uncomplicated P. falciparum malaria. It works by mechanisms characteristic of antimalarial quinolines, with demonstrated effects on cardiac electrophysiology including QTc prolongation. The drug achieves higher exposure in malaria patients than healthy subjects due to disease-related pharmacokinetic changes.
LOE Approaching
Product approaching loss of exclusivity with minimal linked job activity, suggesting a mature brand with limited growth investment and likely smaller commercial team focused on managed care and specialty channels.
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.