NDAORALTABLETPriority Review
Approved
Jul 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
Priority Review
MALARONE (atovaquone and proguanil hydrochloride) by GSK. Approved for antimalarial [epc]. First approved in 2000.
Drug data last refreshed 4d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Malarone is an oral, fixed-dose combination antimalarial containing atovaquone and proguanil hydrochloride, approved in 2000 for malaria prevention and treatment. The dual mechanism targets the parasite's mitochondrial function and folate synthesis, making it effective against Plasmodium falciparum. It is used primarily for travelers and individuals in endemic regions requiring prophylaxis or acute treatment.
$0.003BPart D
LOE ApproachingDeclining
Mature brand with minimal Part D volume and approaching loss of exclusivity signals contraction; expect focus on generic transition management rather than growth initiatives.
Mechanism of Action
Pharmacologic Class:
Antimalarial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on Malarone offers limited growth trajectory but strong operational expertise in malaria therapeutics and global health markets. Expect career value in generic transition management, market access strategy, and specialty travel medicine positioning rather than new product launches.
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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.