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Last Updated: April 24, 2024

Artesunate - Generic Drug Details

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What are the generic drug sources for artesunate and what is the scope of freedom to operate?

Artesunate is the generic ingredient in one branded drug marketed by Amivas and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for artesunate. One supplier is listed for this compound.

Summary for artesunate
Drug Prices for artesunate

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Recent Clinical Trials for artesunate

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Muhimbili University of Health and Allied SciencesPhase 2/Phase 3
Uppsala UniversityPhase 2/Phase 3
The Swedish Research CouncilPhase 2/Phase 3

See all artesunate clinical trials

US Patents and Regulatory Information for artesunate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amivas ARTESUNATE artesunate POWDER;INTRAVENOUS 213036-001 May 26, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amivas ARTESUNATE artesunate POWDER;INTRAVENOUS 213036-001 May 26, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for artesunate

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Amivas Ireland Ltd Artesunate Amivas artesunate EMEA/H/C/005550
Artesunate Amivas is indicated for the initial treatment of severe malaria in adults and children.Consideration should be given to official guidance on the appropriate use of antimalarial agents.
Authorised no no yes 2021-11-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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