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 17h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Malarone is an oral fixed-dose combination of atovaquone and proguanil hydrochloride approved for malaria treatment and prophylaxis. It works through dual antimalarial mechanisms targeting the parasite's mitochondrial and folate synthesis pathways. The combination provides broad-spectrum efficacy against Plasmodium species, including drug-resistant strains.
$0.003BPart D
LOE ApproachingDeclining
Approaching loss of exclusivity with minimal Part D utilization signals contraction phase; limited team expansion expected.
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 experience managing a mature antimalarial franchise in a competitive, generic-pressured environment. Career progression here emphasizes cost management, market defense, and lifecycle extension strategies rather than growth; ideal for professionals developing expertise in LOE transition planning and mature market portfolio management.
Brand Manager
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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.