Viewing data from:

COARTEM

NDA

ARTEMETHER; LUMEFANTRINE | N022268 | NOVARTIS PHARMACEUTICALS CORP

1 strength0 unique patents0 unique exclusivities

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

120 trials from ClinicalTrials.gov, 1 active, 95 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pharmacokinetics and Pharmacodynamics of the Gametocytocidal and Post-treatment Chemoprotective Effects of Antimalarials NCT04009343	Phase 2/3	Active	Johns Hopkins Bloomberg School of Public Health	182	2019-06-19 → 2026-12
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
Interactions Between HIV and Malaria in African Children NCT00527800	Phase 3	Completed	University of California, San Francisco	351	2007-08 → 2013-03
Artemether/Lumefantrine and Nevirapine Interaction Study in HIV-infected Adults NCT00790881	Phase 4	Completed	University of Cape Town	36	2008-10 → 2009-12
Ethiopia Malaria Therapeutic Efficacy Study NCT01052584	N/A	Completed	Centers for Disease Control and Prevention	354	2009-10 → 2010-01
Treatment of Uncomplicated Childhood Malaria in Tanzania by Artemether+Lumefantrine - Efficacy and Genotyping NCT00336375	Phase 4	Completed	Karolinska University Hospital	50	2006-06 → 2006-07
Safety Study on the Effect of Eurartesim™ on QT/QTc Interval Compared to Riamet in Healthy Volunteers NCT01103830	Phase 1	Completed	sigma-tau i.f.r. S.p.A.	287	2010-02 → 2010-12
Longitudinal Antimalarial Combinations in Uganda NCT00123552	Phase 3	Completed	University of California, San Francisco	601	2004-11 → 2008-12
Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria NCT00344006	Phase 3	Completed	GlaxoSmithKline	1,395	2006-06 → 2007-08
Assessing the Efficacy of Artemisinin Combination Therapies for Treatment of Uncomplicated Malaria Infection in Children NCT01082705	Phase 3	Completed	Centers for Disease Control and Prevention	323	2010-04 → 2011-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$5.36

per ea

Lowest NADAC/Unit

$5.36

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00078056845COARTEM TABLETS	$5.36	EA	Brand	—	2026-02-18

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

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

Lowest Price

$100.84

Highest Price

$125.12

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-0568-45COARTEM TAB	$125.12	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0568-45COARTEM TAB	$100.84	Big4	Novartis Pharmaceuticals Corporation	08/31/2026

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

Medicare Part D Spending

CMS annual spending data for Coartem (2024)

Total Spending

$83K

Total Claims

324

Beneficiaries

146

Avg Cost/Unit

$5.59

Spending Trend

$93K(2019)→$75K(2020)→$71K(2021)→$66K(2022)→$95K(2023)→$83K(2024)

YoY Change:-5.8%

5yr CAGR:+1.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Aug 6, 2019	SUPPL -21	View Letter (PDF)
Jan 10, 2018	SUPPL -19	View Letter (PDF)
Mar 20, 2015	SUPPL -12	View Letter (PDF)
May 1, 2013	SUPPL -4	View Letter (PDF)
Aug 7, 2012	SUPPL -3	View Letter (PDF)
Feb 23, 2010	SUPPL -1	View Letter (PDF)
Apr 14, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG;120MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 7, 2009

No patent or exclusivity listings for this strength.