Viewing data from:

MALARONE

NDA

ATOVAQUONE; PROGUANIL HYDROCHLORIDE | N021078 | GLAXOSMITHKLINE

2 strengths0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

21 trials from ClinicalTrials.gov, 16 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Chloroquine Alone or in Combination for Malaria in Children in Malawi NCT00379821	Phase 3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	640	2007-02 → 2012-09
Controlled Human Malaria Infection Model for Evaluation of Transmission-Blocking Interventions - Study 1 NCT02836002	Phase 1/2	Completed	Radboud University Medical Center	29	2016-06 → 2017-06-29
Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis.NCT02564471	Phase 4	Completed	State University of New York - Upstate Medical University	103	2016-11-11 → 2019-02
Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials NCT00451139	Phase 4	Completed	Jimma University	—	—
Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function NCT00444106	Phase 4	Completed	Novartis	265	2007-05 → 2008-11
Safety and Efficacy Study of IV Artesunate to Treat Malaria NCT00298610	Phase 2	Completed	U.S. Army Medical Research and Development Command	30	2006-03 → 2007-10
DSM265 Chemoprophylaxis of Plasmodium Falciparum Malaria NCT02450578	Phase 1	Completed	Medicines for Malaria Venture	22	2015-10 → 2016-04
Target Antigens Induced by Plasmodium Falciparum Sporozoite Immunization Under Chemoprophylaxis NCT02080026	N/A	Completed	Radboud University Medical Center	15	2014-06 → 2015-07
Controlled Human Malaria Infection Model for Evaluation of Transmission-blocking Interventions - Study 2 NCT03454048	N/A	Completed	Radboud University Medical Center	24	2018-05-07 → 2018-11-20
Drug Interaction Study Between Atovaquone and Antiretroviral Agents in HIV-1 Infected Patients NCT00421473	Phase 4	Completed	Radboud University Medical Center	79	2007-03 → 2008-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$1.61

per ea

Lowest NADAC/Unit

$1.61

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66993006002ATOVAQUONE-PROGUANIL 250-100 MG TABLET	$1.61	EA	Generic	—	2026-06-17
66993006027ATOVAQUONE-PROGUANIL 250-100 MG TABLET	$1.61	EA	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 10 NDCs (5 FSS, 5 Big4)

Lowest Price

$12.91

Highest Price

$662.83

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66993-0060-02ATOVAQUONE 250MG/PROGUANIL HCL 100MG TAB	$377.22	FSS	Prasco, LLC	06/30/2026
66993-0060-02ATOVAQUONE 250MG/PROGUANIL HCL 100MG TAB	$146.46	Big4	Prasco, LLC	06/30/2026
66993-0060-27ATOVAQUONE 250MG/PROGUANIL HCL 100MG TAB	$108.76	FSS	Prasco, LLC	06/30/2026
66993-0060-27ATOVAQUONE 250MG/PROGUANIL HCL 100MG TAB	$12.91	Big4	Prasco, LLC	06/30/2026
00173-0675-01MALARONE 250MG/100MG TAB	$662.83	FSS	GlaxoSmithKline	07/31/2027
00173-0675-01MALARONE 250MG/100MG TAB	$514.65	Big4	GlaxoSmithKline	07/31/2027

Showing 6 of 10 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Malarone (2024)

Total Spending

$3K

Total Claims

Beneficiaries

Avg Cost/Unit

$5.96

Spending Trend

$10K(2019)→$3K(2022)→$3K(2023)→$3K(2024)

YoY Change:-14.8%

5yr CAGR:-2.7%

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

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Jun 11, 2026	SUPPL -26	View Letter (PDF)
Mar 24, 2026	SUPPL -25	View Letter (PDF)
Feb 27, 2019	SUPPL -23	View Letter (PDF)
Mar 1, 2013	SUPPL -22	View Letter (PDF)
Nov 9, 2009	SUPPL -17	View Letter (PDF)
Dec 29, 2008	SUPPL -16	View Letter (PDF)
May 9, 2008	SUPPL -14	View Letter (PDF)
Jan 9, 2008	SUPPL -12	View Letter (PDF)
Mar 3, 2005	SUPPL -8	View Letter (PDF)
Mar 3, 2005	SUPPL -9	View Letter (PDF)
Dec 2, 2004	SUPPL -7	View Letter (PDF)
Sep 7, 2004	SUPPL -2	View Letter (PDF)
Dec 8, 2003	SUPPL -6	View Letter (PDF)
Jun 16, 2003	ORIG -1	View Letter (PDF)
Aug 2, 2002	SUPPL -3	View Letter (PDF)
Feb 28, 2002	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 250MG;100MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 14, 2000

No patent or exclusivity listings for this strength.

#002 — 62.5MG;25MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 14, 2000