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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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain11 active DMFs6 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

MATRIX PHARMACORP PRIVATE LTDATOVAQUONE USP

DMF 221342008

HETERO DRUGS LTDATOVAQUONE (FORM-A)

DMF 244462010

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDATOVAQUONE

DMF 253052011

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

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

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.