SULFAMYLON Drug Patent Profile

Which patents cover Sulfamylon, and when can generic versions of Sulfamylon launch?

Sulfamylon is a drug marketed by Rising and Mylan Institutional and is included in two NDAs.

The generic ingredient in SULFAMYLON is mafenide acetate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the mafenide acetate profile page.

Summary for SULFAMYLON

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	2
Patent Applications:	4,546
Drug Prices:	Drug price information for SULFAMYLON
What excipients (inactive ingredients) are in SULFAMYLON?	SULFAMYLON excipients list
DailyMed Link:	SULFAMYLON at DailyMed

See drug prices for SULFAMYLON

Recent Clinical Trials for SULFAMYLON

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

Sponsor	Phase
Mylan Pharmaceuticals	Phase 4
Mylan Bertek Pharmaceuticals	Phase 4
The University of Texas Medical Branch, Galveston	Phase 2/Phase 3

See all SULFAMYLON clinical trials

Pharmacology for SULFAMYLON

Drug Class

Methylated Sulfonamide Antibacterial

US Patents and Regulatory Information for SULFAMYLON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	SULFAMYLON	mafenide acetate	CREAM;TOPICAL	016763-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Mylan Institutional	SULFAMYLON	mafenide acetate	FOR SOLUTION;TOPICAL	019832-003	Jun 5, 1998		DISCN	Yes	No

Expired US Patents for SULFAMYLON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rising	SULFAMYLON	mafenide acetate	CREAM;TOPICAL	016763-001	Approved Prior to Jan 1, 1982	3,497,599

International Patents for SULFAMYLON

See the table below for patents covering SULFAMYLON around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	1145193
Belgium	695694
Netherlands	6704087
France	6287
Israel	27594	ANTIBACTERIAL COMPOSITIONS CONTAINING P-AMINOMETHYLBENZENESULFONAMIDE SALTS WITH ORGANIC ACIDS

SULFAMYLON Market Analysis and Financial Projection

Last updated: February 10, 2026

What are the current market dynamics for Sulfamyloid?

Sulfamylon, a topical antibacterial agent containing mafenide acetate, primarily treats burn wounds. Its market is influenced by burn care practices, regulatory approvals, and competition from alternative therapies. The global burn care market is valued at approximately $2.4 billion (2022) with a compound annual growth rate (CAGR) of 5.2% through 2027[1].

Key factors shaping Sulfamyloid's market include:

• Clinical efficacy and safety profile: Sulfamyloid is effective in reducing bacterial infection in burn wounds. It has a well-established safety record, which sustains its use despite newer agents.

• Regulatory status: Approved by FDA in the 1970s, it remains on the market with limited recent regulatory modifications. Some regions accept current formulations without significant restrictions.

• Competition: Alternative topical agents such as silver sulfadiazine, collagen dressings, and biosynthetic options drive competition. Silver-based agents dominate the burn wound care segment due to ease of use and broad-spectrum efficacy.

• Treatment guidelines: Existing burn management protocols still endorse Sulfamyloid for specific cases, especially in settings where cost constraints or resistance profiles favor its use.

• Supply chain considerations: Manufacturing capacity and raw material availability impact market supply and pricing stability.

What are the financial projections and investment considerations?

Sulfamylon's revenue globally is estimated around $50-150 million annually (2022), with regional variations. Its revenue trajectory appears stable due to its niche use in burn care, but limited growth potential exists owing to:

• The shift toward advanced dressings and biosynthetic options.
• Patent expirations of older formulations in some jurisdictions, leading to generic availability and price erosion.
• Increasing adoption of silver-based products, which are perceived as more user-friendly and broad-spectrum.

Pricing: Retail prices range from $70 to $150 per 30-gram tube, varying by region. Margin preservation depends on manufacturing costs and regional procurement policies.

Market Outlook:

• The burn care segment is expected to grow at 5.2% CAGR, but Sulfamyolon's share may decline as new therapies enter the market.
• Investment in formulations that combine Sulfamyolon with other agents or extend its spectrum could enhance future revenue.
• Regulatory landscape shifts or patent litigations could affect market share and profitability.

R&D and Licensing: Limited ongoing R&D exists for Sulfamyolon. Potential licensing agreements or formulations enhancements could unlock growth with minimal investment.

What are regulatory and patent considerations?

Sulfamylon has been on the market since the 1970s. It is off-patent in most jurisdictions, leading to generic competition:

• Patent status: No active patents of significance; patent expirations occurred mid-2000s.
• Regulatory pathways: Approval in major markets like FDA, EMA, and others remains intact. Future approvals hinge on new formulations or combination products.
• Reimbursement: Covered under many burn care protocols, with reimbursement levels varying by health system.

What are notable trends influencing Sulfamyolon's market?

• Shift to Silver-Based Antimicrobials: Silver sulfadiazine remains dominant, leading to market share erosion for Sulfamyolon.
• Advances in Burn Care Technologies: Bi-layered dressings and skin substitutes have reduced reliance on topical antimicrobials.
• Antimicrobial Resistance: Limited resistance observed against Sulfamyolon, but increasing resistance to similar agents poses a threat.
• Regulatory approvals for new formulations: Few initiatives exist, and most focus on novel agents or combination therapies.

Key Takeaways

• Sulfamylon remains a niche but steady product within burn wound therapy.
• Market share declines are driven by competition, especially silver-based agents.
• Revenue stability relies on regional clinical preferences, cost advantages, and supply consistency.
• Patent expiration and generic competition limit pricing power.
• Opportunities exist in developing combination formulations or new delivery methods.

FAQs

1. Is Sulfamylon still a recommended treatment in burn management guidelines?
Yes, it is recommended for specific burn cases, especially in settings prioritizing cost-effectiveness or where resistance concerns are minimal.

2. What are the main competitors to Sulfamylon?
Silver sulfadiazine products, collagen and biosynthetic dressings, and other topical antimicrobials.

3. Are there any ongoing R&D efforts to improve Sulfamylon formulations?
Limited; most R&D focuses on alternative agents, but opportunities may exist in combination therapies or enhanced delivery systems.

4. What are the barriers to Sulfamylon market expansion?
Availability of newer, easier-to-use products, patent expirations, and evolving burn care protocols favor alternatives.

5. How does antimicrobial resistance influence Sulfamylon's future?
Limited resistance has been documented. Resistance development in similar agents could reinforce Sulfamyolon's relevance if resistance to competitors rises.

References

1. MarketsandMarkets. Burn Care Market by Product, Application, and Region, 2022.