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SILVADENE

NDA

SILVER SULFADIAZINE | N017381 | KING PHARMACEUTICALS 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Sage Pharmaceuticals FDA-1997-P-0421 Sage Pharmaceuticals, Inc. filed this citizen petition on June 26, 1997 pursuant to section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act requesting permission to file an Abbreviated New Drug Application for silver sulfadiazine 1% cream packaged in a non-aerosol spray container with the s	Other	2017-08-30	Withdrawn	Sage Pharmaceuticals

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

Clinical Trials

2 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Overnight Thalamic TES-TI to Modulate Sleep Spindles in Individuals With Schizophrenia Spectrum Disorders and Matched Healthy Controls NCT07680114	N/A	Not Yet Recruiting	University of Wisconsin, Madison	20	2026-08 → 2027-12
Cochlear Implants in Young Children With SSD NCT05775367	N/A	Recruiting	University of North Carolina, Chapel Hill	60	2023-07-07 → 2030-05-30

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

Medicare Part D Spending

CMS annual spending data for Silvadene (2023)

Total Spending

$31K

Total Claims

1,100

Beneficiaries

925

Avg Cost/Unit

$0.18

Spending Trend

$52K(2019)→$48K(2020)→$37K(2021)→$29K(2022)→$31K(2023)

YoY Change:+13.5%

5yr CAGR:-0.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain6 active DMFs5 inactive

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

LEK PHARMACEUTICALS DDSILVER SULFADIAZINE

DMF 42971981

TAPI NL BVSILVER SULFADIAZINE

DMF 116621995

AMISHI DRUGS AND CHEMICALS PVT LTDSILVER SULFADIAZINE USP

DMF 220832008

LUSOCHIMICA SPASILVER SULFADIAZINE

DMF 291142015

INDIA PHOSPHATE AND ALLIED INDUSTRIES PRIVATE LTDSILVER SULFADIAZINE USP

DMF 292292015

MACSEN DRUGSSILVER SULFADIAZINE USP

DMF 330522018

MALLINCKRODT INCInactiveSILVER SULFADIAZINE

DMF 20131972

NAPP CHEMICALS INCInactiveSILVER SULFADIAZINE

DMF 41871981

FINE CHEMICALS CORPInactiveSILVER SULFADIAZINE

DMF 59081985

DSM ANDENO GMBHInactiveSILVER SULFADIAZINE

DMF 61501986

DSM MINERA BVInactiveSILVER SULFADIAZINE

DMF 147572000

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Apr 27, 2017	SUPPL -53	View Letter (PDF)
Mar 6, 2013	SUPPL -50	View Letter (PDF)
Feb 3, 2004	SUPPL -41	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLDAB

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.