NDAORALTABLETPriority Review
Approved
Apr 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
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 12h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COARTEM is an oral fixed-dose combination antimalarial containing artemether and lumefantrine, approved by the FDA in 2009. It treats acute uncomplicated malaria infections caused by Plasmodium falciparum and other Plasmodium species. The combination works through dual mechanisms targeting the malaria parasite at different lifecycle stages.
$0.095MPart D
LOE ApproachingThe product is approaching loss of exclusivity with modest Part D utilization (301 claims in 2023), suggesting a mature, stable market with limited team expansion opportunities.
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 (4)
Study to Assess Safety and Clinical Responses With Coartem® Baby Dispersible Tablets in Paediatric Patients Weighing 2 to <5 kg With Uncomplicated Malaria
Started Jun 2027
20 enrolled
Malaria
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
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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.