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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 · 7 docket documents 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Drug Application for silver sulfadiazine 1% cream packaged in a non-aerosol spray container with the s	Other	2017-08-30	Withdrawn	Sage Pharmaceuticals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

13 trials from ClinicalTrials.gov — 1 recruiting, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns NCT01297400	Phase 2	Recruiting	Skingenix, Inc.	60	2022-03-11 → 2026-12-31
A Trial Comparing the Efficacy and Safety of Open Dressing With Petrolatum Jelly vs. Standard Gauze Dressing With Silver Sulfadiazine NCT02109718	Phase 3	Completed	University of the Philippines	50	2009-01 → 2010-07
Use of Nile Tilapia Fish Skin as a Xenograft for Burn Treatment: Phase III Study NCT04202289	Phase 3	Completed	Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara	115	2017-04-03 → 2018-10-24
Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Burn NCT03162367	Phase 2	Completed	SCARM Institute, Tabriz, Iran	40	2019-04-10 → 2020-03-15
Effect of EGF With Silver Sulfadiazine Cream Compared With Silver Zinc Sulfadiazine Cream for Treatment of Burn Wound NCT01553708	Phase 2/3	Completed	Chulalongkorn University	34	2011-12 → 2012-05
Comparison of a Water-soluble Topical Antimicrobial to Silver Sulfadiazine in Partial Thickness Burns NCT01926392	Phase 4	Completed	University of Virginia	8	2011-04 → 2011-10
Study to Evaluate the Use of Tilapia Skin (Oreochromis Niloticus), in the Treatment of Burn Wounds NCT03592498	Phase 2	Completed	Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara	63	2016-10-05 → 2017-09-20
Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns NCT02108535	Phase 4	Completed	University of Sorocaba	100	2013-11 → 2014-10
The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns NCT00156988	Phase 4	Completed	Association of Dutch Burn Centres	—	2004-03 → 2005-12
Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns NCT03564795	N/A	Terminated	KeraNetics, LLC	14	2018-08-31 → 2023-03-31

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 12 NDCs (6 brand, 6 generic)

Highest NADAC/Unit

$0.4341

per gm

Lowest NADAC/Unit

$0.1247

per gm

Brand NDCs

Generic NDCs

Avg Brand: $0.2683

Avg Generic: $0.2631

2% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61570013120SILVADENE 1% CREAM	$0.4341	GM	Brand	$0.3859	2026-06-17
59762013100SILVER SULFADIAZINE 1% CREAM	$0.3859	GM	Generic	—	2026-06-17
59762013102SILVER SULFADIAZINE 1% CREAM	$0.3150	GM	Generic	—	2026-06-17
61570013125SILVADENE 1% CREAM	$0.2886	GM	Brand	$0.3150	2026-07-01
61570013185SILVADENE 1% CREAM	$0.2732	GM	Brand	$0.2486	2026-07-01
59762013106SILVER SULFADIAZINE 1% CREAM	$0.2510	GM	Generic	—	2026-06-17

Showing 6 of 12 NDCs.

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 26 NDCs (13 FSS, 13 Big4)

Lowest Price

$2.24

Highest Price

$115.62

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59762-0131-02SILVER SULFADIAZINE 1% CREAM,TOP	$3.57	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-0131-02SILVER SULFADIAZINE 1% CREAM,TOP	$2.24	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-0131-04SILVER SULFADIAZINE 1% CREAM,TOP	$22.20	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-0131-04SILVER SULFADIAZINE 1% CREAM,TOP	$11.17	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-0131-00SILVER SULFADIAZINE 1% CREAM,TOP	$4.28	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-0131-00SILVER SULFADIAZINE 1% CREAM,TOP	$2.48	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027

Showing 6 of 26 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Silvadene (2024)

Total Spending

$29K

Total Claims

1,023

Beneficiaries

867

Avg Cost/Unit

$0.15

Spending Trend

$52K(2019)→$48K(2020)→$37K(2021)→$29K(2022)→$31K(2023)→$29K(2024)

YoY Change:-16.8%

5yr CAGR:-4.5%

Source: CMS Medicare Part D Spending by Drug (2024). 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.