ARTESUNATE - Generic Drug Details

✉ Email this page to a colleague

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

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	231
Patent Applications:	1,599
Drug Prices:	Drug price trends for ARTESUNATE
What excipients (inactive ingredients) are in ARTESUNATE?	ARTESUNATE excipients list
DailyMed Link:	ARTESUNATE at DailyMed

See drug prices for ARTESUNATE

Recent Clinical Trials for ARTESUNATE

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

Sponsor	Phase
UNC Lineberger Comprehensive Cancer Center	Phase 1
Gilead Sciences	Phase 1
Joseph C. Wu	Phase 1

See all ARTESUNATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ARTESUNATE

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

US Patents and Regulatory Information for ARTESUNATE

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amivas	ARTESUNATE	artesunate	POWDER;INTRAVENOUS	213036-001	May 26, 2020		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

EU/EMA Drug Approvals for ARTESUNATE

Subscribe to access the full database, or Sign Up
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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.