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SULFADIAZINE

NDA

SULFADIAZINE | N004122 | ELI LILLY AND CO

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Rising Pharma Holdings Inc. FDA-2025-P-0394 Rising Pharma Holdings, Inc. submitted a citizen petition under Section 505(j) requesting that the FDA determine whether Sulfadiazine Tablets USP 500 mg (NDA 004122, held by Eli Lilly and Co.) was withdrawn from commercial distribution for safety or effectiveness reasons. The petitioner seeks FDA co	505(q)	2025-02-06	Denied	Rising Pharma Holdings Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs5 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

HUNAN XIANGYIKANG PHARMACEUTICAL CO LTDSULFADIAZINE USP

DMF 332372018

ANDHRA ORGANICS LTDSULFADIAZINE USP

DMF 382682023

ACF CHEMIEFARMA NVInactiveSULFADIAZINE

DMF 39411980

GUANGDONG PHARMACEUTICAL FACTORYInactiveSULFADIAZINE AND SULFADIAZINE SODIUM

DMF 82901989

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDInactiveSULFADIAZINE

DMF 86991990

YUKI GOSEI KOGYO CO LTDInactiveSULFADIAZINE SILVER

DMF 91121991

SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTDInactiveSULFADIAZINE

DMF 226922009

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

Products (1)

#002 — 500MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.