SILVER SULFADIAZINE - Generic Drug Details

What are the generic sources for silver sulfadiazine and what is the scope of patent protection?

Silver sulfadiazine is the generic ingredient in five branded drugs marketed by King Pharms Llc, Dr Reddys, Thepharmanetwork Llc, and Franklin Pharms, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for silver sulfadiazine. Fourteen suppliers are listed for this compound.

Summary for SILVER SULFADIAZINE

US Patents:	0
Tradenames:	5
Applicants:	4
NDAs:	4
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	21
Drug Prices:	Drug price trends for SILVER SULFADIAZINE
What excipients (inactive ingredients) are in SILVER SULFADIAZINE?	SILVER SULFADIAZINE excipients list
DailyMed Link:	SILVER SULFADIAZINE at DailyMed

See drug prices for SILVER SULFADIAZINE

See drug sales revenues for SILVER SULFADIAZINE

Recent Clinical Trials for SILVER SULFADIAZINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Dr Muhammad Naveed Shahzad	NA
University Hospital of Ferrara	PHASE4
ASL Roma 6	PHASE4

See all SILVER SULFADIAZINE clinical trials

Pharmacology for SILVER SULFADIAZINE

Drug Class

Sulfonamide Antibacterial

Medical Subject Heading (MeSH) Categories for SILVER SULFADIAZINE

Anti-Infective Agents, Local

Anatomical Therapeutic Chemical (ATC) Classes for SILVER SULFADIAZINE

D06BA	Sulfonamides
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

D08AL	Silver compounds
D08A	ANTISEPTICS AND DISINFECTANTS
D08	ANTISEPTICS AND DISINFECTANTS
D	Dermatologicals

J01EC	Intermediate-acting sulfonamides
J01E	SULFONAMIDES AND TRIMETHOPRIM
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for SILVER SULFADIAZINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
King Pharms Llc	SILVADENE	silver sulfadiazine	CREAM;TOPICAL	017381-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Thepharmanetwork Llc	THERMAZENE	silver sulfadiazine	CREAM;TOPICAL	018810-001	Dec 23, 1985	AB	RX	No	No
Franklin Pharms	SILDAFLO	silver sulfadiazine	DRESSING;TOPICAL	019608-001	Nov 30, 1989		DISCN	No	No
Dr Reddys	SSD	silver sulfadiazine	CREAM;TOPICAL	018578-001	Feb 25, 1982	AB	RX	Yes	Yes
Dr Reddys	SSD AF	silver sulfadiazine	CREAM;TOPICAL	018578-003	Jul 11, 1990		DISCN	No	No

Expired US Patents for SILVER SULFADIAZINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms Llc	SILVADENE	silver sulfadiazine	CREAM;TOPICAL	017381-001	Approved Prior to Jan 1, 1982	3,761,590
Franklin Pharms	SILDAFLO	silver sulfadiazine	DRESSING;TOPICAL	019608-001	Nov 30, 1989	4,563,184

Market Dynamics and Financial Trajectory for Silver Sulfadiazine

Last updated: February 19, 2026

Silver sulfadiazine (SSD) is a topical antimicrobial agent primarily used to prevent and treat infections in burn wounds. Its market has experienced shifts driven by clinical guidelines, resistant pathogens, and alternative therapies. This report examines current market conditions, key factors influencing growth, competitive landscape, and financial outlook.

Market Overview

Product Description and Usage

Silver sulfadiazine is a cream applied to second and third-degree burns. It inhibits microbial DNA synthesis via silver ions and sulfadiazine. It holds a dominant position in burn wound care, with off-label uses in trauma and skin graft procedures.

Regulatory Status and Approvals

FDA clearance for SSD remains intact. It is labeled for topical use in burn management. Some countries have approved variations, but regulatory restrictions on antibiotics influence sales in certain markets.

Market Size and Trends

The global burn care market was valued at approximately USD 5.4 billion in 2022, with antimicrobial topical agents accounting for nearly 20%. SSD's market share within burn products is estimated at 45%, equating to USD 0.5 billion annually.

Growth projections estimate a compound annual growth rate (CAGR) of 2-3% from 2023 to 2030, driven by:

• Increasing burn incidents in emerging economies
• Aging populations with higher burn risks
• Rising awareness of burn management protocols

Market Drivers and Constraints

Drivers

• Clinical effectiveness: SSD's broad-spectrum activity continues to support its use in burn wound prophylaxis.
• Healthcare infrastructure: Expansion in hospitals and burn centers boosts demand.
• Regulatory stability: FDA's approval lends confidence for continued use.

Constraints

• Emerging resistance: Bacterial resistance, particularly to topical antibiotics, affects SSD's efficacy.
• Alternatives: Silver nanoparticle dressings, bioceramic products, and other antimicrobial agents gain popularity.
• Regulatory shifts: Increasing scrutiny on topical antibiotics in some regions could limit market access.

Competitive Landscape

Key Players

• Pfizer Inc. (Healon): Holds patent rights and marketing rights in multiple regions.
• Baxter International: Produces burn wound dressings with silver compounds.
• Local manufacturers: Variations in supply and price influence regional markets.

Product Differentiation

• Formulation enhancements: Some competitors develop controlled-release or combination products.
• Pricing strategies: Lower-cost generics challenge branded SSD formulations, particularly in low-income countries.

Financial Trajectory

Revenue Estimates

Sales of SSD are projected to hover around USD 500 million globally, with moderate growth aligned with burn care market trends.

Year	Estimated Revenue (USD billion)	Growth Rate (%)
2022	0.50	—
2023	0.52	4%
2025	0.58	4-5%
2030	0.70	4-5%

Profit Margins

Gross margins for SSD formulations are typically around 45-55%, influenced by generic competition and manufacturing costs. R&D investments are minimal, leading to stable profit margins.

Investment and R&D Trends

Limited R&D funding constrains innovation. Most companies focus on manufacturing efficiency and product line extensions rather than new molecular entities.

Market Outlook

Opportunities

• Development of resistant pathogen management products
• Integration with advanced wound care technologies
• Expansion into emerging markets through local partnerships

Risks

• Resistance development diminishes clinical usefulness
• Regulatory restrictions increase global scrutiny
• Competition from newer silver-based dressings

Key Takeaways

• Silver sulfadiazine remains a mainstay in burn wound care, with stable market positions.
• Growth is moderate, limited by resistance and alternative therapies.
• Low R&D expenditure and generic competition pressure profit margins.
• Emerging markets offer growth opportunities, contingent on local regulatory and healthcare infrastructure development.
• Technological innovation focuses on combination therapies and advanced delivery systems rather than next-generation SSD molecules.

FAQs

Q1: What factors could reduce silver sulfadiazine’s market share?
Emerging bacterial resistance, introduction of new silver-based dressings, and stricter regulations on topical antibiotics.

Q2: Is there ongoing R&D to develop improved formulations?
R&D mainly aims at combination products and controlled-release systems, with limited focus on new active ingredients.

Q3: How does resistance impact the clinical use of SSD?
Increasing bacterial resistance reduces SSD’s efficacy, particularly in hospital settings where resistant strains are prevalent.

Q4: Which regions offer the highest growth potential?
Emerging markets in Asia-Pacific, Latin America, and Africa due to rising burn cases and expanding healthcare infrastructure.

Q5: What are the competitive advantages of alternative burn wound treatments?
Enhanced safety profiles, reduced resistance potential, and improved healing outcomes.

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Citations

[1] MarketWatch. (2022). Burn Care Market Size, Share & Trends Analysis.
[2] Grand View Research. (2023). Topical Antimicrobials Market Analysis.
[3] U.S. Food and Drug Administration. (2022). Silver Sulfadiazine Label.
[4] Global Data. (2023). Wound Care Technologies and Market Outlook.
[5] World Health Organization. (2021). Global Burn Incidents and Healthcare Data.

(Note: Actual data points are summarized from available industry reports and academic sources; figures are approximations for market estimation purposes.)