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ARTESUNATE

NDA

ARTESUNATE | N213036 | AMIVAS INC

1 strength2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

Active (2)TodayExclusivity

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Today

12121506

Feb. 16, 2044

12390442

Feb. 16, 2044

ODE-290

May. 26, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

167 trials from ClinicalTrials.gov — 1 recruiting, 138 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)NCT04098744	Phase 2	Recruiting	Frantz Viral Therapeutics, LLC	78	2020-09-09 → 2026-12-31
Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria NCT00344006	Phase 3	Completed	GlaxoSmithKline	1,395	2006-06 → 2007-08
Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects NCT00894374	Phase 1	Completed	Pfizer	40	2009-06 → 2009-08
In Vivo Efficacy of Artemether-Lumefantrine and Artesunate-Amodiaquine for Uncomplicated P. Falciparum Malaria NCT02637128	Phase 4	Completed	Centers for Disease Control and Prevention	452	2014-03 → 2014-07
A Randomised Trial of Artekin and Artesunate & Amodiaquine for Uncomplicated Malaria in Timika, Papua, Indonesia.NCT00157885	N/A	Completed	Menzies School of Health Research	400	2005-07 → 2005-12
Study of the Safety of Intravenous Artesunate NCT00292942	Phase 1	Completed	U.S. Army Medical Research and Development Command	26	2006-06-12 → 2008-01
Trial of Artesunate Combination Therapy in Pakistan NCT00959517	Phase 2	Completed	London School of Hygiene and Tropical Medicine	588	2001-07 → 2006-08
Longitudinal Antimalarial Combinations in Uganda NCT00123552	Phase 3	Completed	University of California, San Francisco	601	2004-11 → 2008-12
Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients NCT00422084	Phase 3	Completed	Medicines for Malaria Venture	1,272	2007-01 → 2008-05
Bioequivalence Trial of Pyronaridine Artesunate To-be-marketed Tablet to the Clinical Trial Reference Tablet NCT00682630	Phase 1	Completed	Medicines for Malaria Venture	42	2007-09 → 2008-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$7728.81

Highest Price

$10425.34

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
73607-0011-11ARTESUNATE 110MG/VIAL INJ	$10425.34	FSS	Amivas, LLC	08/14/2026
73607-0011-11ARTESUNATE 110MG/VIAL INJ	$7728.81	Big4	Amivas, LLC	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain2 active DMFs3 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SOLARA ACTIVE PHARMA SCIENCES LTDARTESUNATE

DMF 240282010

OLON SPAARTESUNATE

DMF 316862017

CIPLA LTDInactiveARTESUNATE

DMF 201882008

IPCA LABORATORIES LTDInactiveARTESUNATE

DMF 222182009

HUVEPHARMA ITALIA SRLInactiveARTESUNATE

DMF 278252013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Apr 15, 2026	SUPPL -13	View Letter (PDF)
Jan 17, 2025	SUPPL -8	View Letter (PDF)
Aug 1, 2023	SUPPL -4	View Letter (PDF)
Mar 6, 2023	SUPPL -3	View Letter (PDF)
Feb 7, 2022	SUPPL -1	View Letter (PDF)
May 27, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 110MG/VIAL

RLD

2 patents1 exclusivity▴

POWDER;INTRAVENOUS | Approved: May 26, 2020

Patents (2) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
12121506	Feb 16, 2044	—	—	Yes	—	—
12390442	Feb 16, 2044	—	—	—		—

Exclusivities (1)

Code	Date	Status
ODE-290	May 26, 2027	< 1 year