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

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
First-in-Human PfSPZ-LARC2 Vaccination/CHMI NCT06735209	Phase 1	Active	National Institute of Allergy and Infectious Diseases (NIAID)	22	2025-07-23 → 2027-03-30

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

Medicare Part D Spending

CMS annual spending data for Malarone (2023)

Total Spending

$3K

Total Claims

Beneficiaries

Avg Cost/Unit

$7.00

Spending Trend

$10K(2019)→$3K(2022)→$3K(2023)

YoY Change:+11.2%

5yr CAGR:+2.4%

Source: CMS Medicare Part D Spending by Drug (2023). 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