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Last Updated: April 24, 2024

ARTESUNATE Drug Patent Profile


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When do Artesunate patents expire, and when can generic versions of Artesunate launch?

Artesunate is a drug marketed by Amivas and is included in one NDA.

The generic ingredient in ARTESUNATE is artesunate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the artesunate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Artesunate

A generic version of ARTESUNATE was approved as artesunate by AMIVAS on May 26th, 2020.

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Summary for ARTESUNATE
Drug patent expirations by year for ARTESUNATE
Drug Prices for ARTESUNATE

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Recent Clinical Trials for ARTESUNATE

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

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

See all ARTESUNATE clinical trials

US Patents and Regulatory Information for ARTESUNATE

ARTESUNATE is protected by zero US patents and two FDA Regulatory Exclusivities.

FDA Regulatory Exclusivity protecting ARTESUNATE

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

INDICATED FOR THE INITIAL TREATMENT OF SEVERE MALARIA IN ADULT AND PEDIATRIC PATIENTS TO ALWAYS BE FOLLOWED BY A COMPLETE TREATMENT COURSE OF AN APPROPRIATE ORAL ANTIMALARIAL REGIMEN
Exclusivity Expiration: ⤷  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
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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