NDAORALTABLETPriority Review
Approved
Apr 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
5/8 — Partial
Priority Review
COARTEM (artemether and lumefantrine) by Novartis. Approved for antimalarial [epc]. First approved in 2009.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COARTEM is an oral fixed-dose combination of artemether and lumefantrine, two antimalarial agents with complementary mechanisms of action. It is indicated for the treatment of uncomplicated malaria caused by Plasmodium falciparum and other Plasmodium species. The artemether component acts rapidly to reduce parasite burden, while lumefantrine provides sustained suppression and cure.
$0.095MPart D
LOE ApproachingLimited U.S. market presence with modest Part D spending signals a niche product; career opportunities focus on international development and tropical medicine specialization rather than large-scale domestic commercialization.
Mechanism of Action
Pharmacologic Class:
Antimalarial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
A Community Setting Study of Malaria After Systematic Treatment of Symptomatic Carriers of P. Falciparum With COA566 (Coartem®)
Started Nov 2010
14,075 enrolled
Malaria
Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks
Started Jun 2008
413 enrolled
Malaria
Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria
Started Jun 2006
1,395 enrolled
Malaria, Falciparum
Career Relevance
Working on COARTEM offers specialized expertise in global malaria treatment, regulatory navigation in endemic countries, and supply chain management for tropical medicines. Career growth is constrained by modest U.S. market size and approaching LOE, but international and medical affairs roles provide deep disease and market knowledge.
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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.