Viewing data from:

MEPRON

NDA

ATOVAQUONE | N020500 | GLAXOSMITHKLINE LLC

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

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

37 trials from ClinicalTrials.gov, 29 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients NCT00000655	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	300	—
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
An Open-Label, Uncontrolled Clinical Trial of Oral 566C80 for the Treatment of Patients With Severe PCP Who Are Intolerant and/or Unresponsive to Therapy With Trimethoprim/Sulfamethoxazole and Parenteral Pentamidine NCT00001990	N/A	Completed	Glaxo Wellcome	—	—
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
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
A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients Who Are Intolerant of Trimethoprim / Sulfamethoxazole NCT00001996	Phase 2	Completed	Glaxo Wellcome	—	—
DSM265 Chemoprophylaxis of Plasmodium Falciparum Malaria NCT02450578	Phase 1	Completed	Medicines for Malaria Venture	22	2015-10 → 2016-04

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$1004.53

Highest Price

$1464.72

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00173-0547-00MEPRON SUSUPUD 750MG/5ML	$1259.58	FSS	GlaxoSmithKline	07/31/2027
00173-0547-00MEPRON SUSUPUD 750MG/5ML	$1004.53	Big4	GlaxoSmithKline	07/31/2027
00173-0665-18MEPRON SUSPENSION 750MG/5ML	$1464.72	FSS	GlaxoSmithKline	07/31/2027
00173-0665-18MEPRON SUSPENSION 750MG/5ML	$1090.94	Big4	GlaxoSmithKline	07/31/2027

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

API Supply Chain12 active DMFs7 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

ZYDUS LIFESCIENCES LTDATOVAQUONE USP

DMF 209082007

ALCHYMARS ICM SM PRIVATE LTDATOVAQUONE USP

DMF 220572008

ALIVUS LIFE SCIENCES LTDATOVAQUONE, USP

DMF 221212008

MATRIX PHARMACORP PRIVATE LTDATOVAQUONE USP

DMF 221342008

HETERO DRUGS LTDATOVAQUONE (FORM-A)

DMF 244462010

TARO PHARMACEUTICAL INDUSTRIES LTDATOVAQUONE USP, MICRONIZED

DMF 269062013

ALIVUS LIFE SCIENCES LTDATOVAQUONE USP (D144 PROCESS)

DMF 311422016

APITORIA PHARMA PRIVATE LTDATOVAQUONE USP

DMF 316752017

NURAY CHEMICALS PRIVATE LTDATOVAQUONE USP

DMF 363392021

HETERO DRUGS LTDATOVAQUONE (FORM-A), PROCESS II

DMF 409522024

IPCA LABORATORIES LTDATOVAQUONE USP

DMF 422012025

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDATOVAQUONE

DMF 436222026

USV LTDInactiveATOVAQUONE USP

DMF 206722007

ZHEJIANG HISOAR PHARMACEUTICAL CO LTDInactiveAtovaquone

DMF 210012007

ROLABO OUTSOURCING SLInactiveATOVAQUONE USP

DMF 213602008

EXCELLA GMBHInactiveATOVAQUONE

DMF 214682008

USV PRIVATE LTDInactiveATOVAQUONE USP (FORM III)

DMF 235132010

USV PRIVATE LTDInactiveATOVAQUONE USP (FORM I)

DMF 235562010

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDInactiveATOVAQUONE

DMF 253052011

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Mar 23, 2026	SUPPL -20	View Letter (PDF)
Jul 19, 2019	SUPPL -19	View Letter (PDF)
Feb 27, 2019	SUPPL -17	View Letter (PDF)
Oct 18, 2017	SUPPL -16	View Letter (PDF)
Jun 10, 2015	SUPPL -15	View Letter (PDF)
Mar 4, 2013	SUPPL -14	View Letter (PDF)
May 9, 2008	SUPPL -10	View Letter (PDF)
Jun 9, 2004	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 750MG/5ML

RLDAB

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Feb 8, 1995

No patent or exclusivity listings for this strength.