AA(FDC) — Competitive Intelligence Brief

AA(FDC) (AA(FDC)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antimalarial combination. Area: Infectious Disease.

marketed Antimalarial combination Plasmodium falciparum (multiple mechanisms: artemisinin-based ROS generation and quinoline-based heme polymerization inhibition) Infectious Disease Small molecule

Target snapshot

AA(FDC) (AA(FDC)) — Medecins Sans Frontieres, Netherlands. AA(FDC) is a fixed-dose combination antimalarial therapy containing artesunate and amodiaquine that works by disrupting parasite metabolism and preventing malaria infection.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
AA(FDC) TARGET	AA(FDC)	Medecins Sans Frontieres, Netherlands	marketed	Antimalarial combination	Plasmodium falciparum (multiple mechanisms: artemisinin-based ROS generation and quinoline-based heme polymerization inhibition)
amodiaquine-artesunate versus amodiaquine	amodiaquine-artesunate versus amodiaquine	Charite University, Berlin, Germany	marketed	Antimalarial combination	Malaria parasite heme detoxification pathway; artemisinin-derived endoperoxide bridge
SP-IPTp	SP-IPTp	London School of Hygiene and Tropical Medicine	marketed	Antimalarial combination therapy	Plasmodium falciparum dihydrofolate reductase (sulfadoxine-pyrimethamine); hemozoin formation (piperaquine)
IPTp-DP	IPTp-DP	Kenya Medical Research Institute	marketed	Antimalarial combination therapy	Plasmodium falciparum (malaria parasite)
Artemether + Lumefantrine	Artemether + Lumefantrine	GlaxoSmithKline	marketed	Antimalarial combination	Plasmodium falciparum hemoglobin metabolism and heme detoxification pathway
Sulfadoxine-pyrimethamine plus artesunate	Sulfadoxine-pyrimethamine plus artesunate	London School of Hygiene and Tropical Medicine	marketed	Antimalarial combination	Dihydrofolate reductase, dihydropteroate synthase (sulfadoxine-pyrimethamine); mitochondrial electron transport (artesunate)
Artesunate + Amodiaquine	Artesunate + Amodiaquine	Professor Anders Björkman	marketed	Antimalarial combination	Plasmodium falciparum hemoglobin metabolism and DNA synthesis

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Antimalarial combination class)

1. Centers for Disease Control and Prevention · 4 drugs in this class
2. Armed Forces Research Institute of Medical Sciences, Thailand · 4 drugs in this class
3. London School of Hygiene and Tropical Medicine · 3 drugs in this class
4. Sanofi · 2 drugs in this class
5. Menzies School of Health Research · 2 drugs in this class
6. Fundação de Medicina Tropical Dr. Heitor Vieira Dourado · 1 drug in this class
7. Epicentre · 1 drug in this class
8. Jhpiego · 1 drug in this class
9. Charite University, Berlin, Germany · 1 drug in this class
10. Ifakara Health Institute · 1 drug in this class