Artemether; lumefantrine - Generic Drug Details

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What are the generic sources for artemether; lumefantrine and what is the scope of freedom to operate?

Artemether; lumefantrine is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for artemether; lumefantrine

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	179
DailyMed Link:	artemether; lumefantrine at DailyMed

Recent Clinical Trials for artemether; lumefantrine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ifakara Health Institute	Phase 1
Global Fund	Phase 4
The Swedish Research Council	Phase 2/Phase 3

See all artemether; lumefantrine clinical trials

Pharmacology for artemether; lumefantrine

Drug Class	Antimalarial

Anatomical Therapeutic Chemical (ATC) Classes for artemether; lumefantrine

P01BE	Artemisinin and derivatives, plain
P01B	ANTIMALARIALS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

P01BF	Artemisinin and derivatives, combinations
P01B	ANTIMALARIALS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for artemether; lumefantrine

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	COARTEM	artemether; lumefantrine	TABLET;ORAL	022268-001	Apr 7, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for artemether; lumefantrine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	COARTEM	artemether; lumefantrine	TABLET;ORAL	022268-001	Apr 7, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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