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
Israel	27594	ANTIBACTERIAL COMPOSITIONS CONTAINING P-AMINOMETHYLBENZENESULFONAMIDE SALTS WITH ORGANIC ACIDS
Belgium	695694
Netherlands	6704087
United Kingdom	1145193
France	6287

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SULFAMYLON

Last updated: July 31, 2025

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Introduction

SULFAMYLON, a sulfonamide antibiotic, has long been recognized for its therapeutic efficacy in managing bacterial infections, notably urinary tract infections and certain respiratory conditions. Despite its age and the waning prevalence of sulfonamide antibiotics, recent developments suggest a potential resurgence driven by novel formulations, targeted applications, and regulatory shifts. This analysis explores SULFAMYLON's current market landscape, dynamics influencing its growth or decline, and its projected financial trajectory.

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Historical Context and Pharmaceutical Profile

SULFAMYLON was introduced in the mid-20th century as a pioneering antibiotic, leveraging sulfonamide chemistry. Historically, it experienced widespread adoption due to effectiveness and affordability. However, the emergence of bacterial resistance, adverse effects, and the advent of more sophisticated antimicrobial agents like fluoroquinolones and cephalosporins led to a decline in its clinical use.

Today, SULFAMYLON remains available in many markets, primarily as a generic product, but its market share has contracted substantially. Nonetheless, recent research into its derivatives, combination therapies, and niche applications rekindle interest around its relevance.

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Market Dynamics Influencing SULFAMYLON

1. Resistance and Clinical Efficacy

A primary driver of SULFAMYLON's diminishing market presence has been the rise of bacterial resistance, particularly among Escherichia coli and other pathogenic organisms. Many clinical guidelines now prefer other antibiotics due to resistance patterns and safety concerns (e.g., hypersensitivity reactions). Nonetheless, in regions with limited access to newer therapies, SULFAMYLON continues to serve as an affordable alternative, especially in low- and middle-income countries (LMICs).

2. Regulatory and Patent Landscape

SULFAMYLON's patent expirations have led to a proliferation of generic manufacturers, further lowering prices and increasing accessibility. However, regulatory agencies like the FDA and EMA have clamped down on older antibiotics with safety issues for broader indications, which constrains large-scale reformulations. Conversely, some regulators are examining its safety profile to determine if new labeling or formulations can extend its usability.

3. Developments in Formulations and Derivatives

Recent pharmaceutical research explores SULFAMYLON derivatives with improved safety profiles, pharmacokinetics, and targeted delivery systems. These innovations could create niche markets or extend its clinical relevance. Notably, fixed-dose combinations with other antimicrobials aim to combat multi-drug resistant bacteria, which may help reintroduce SULFAMYLON-based therapies.

4. Emerging Market Relevance

In certain developing nations, SULFAMYLON faces less competition, retaining a foothold as a cost-effective antibiotic. Increased government procurement programs and local manufacturing further support its market presence. Additionally, global health initiatives focus on antibiotics stewardship, which may impact prescribing patterns favorably or unfavorably depending on regulatory perspectives.

5. Impact of Antimicrobial Stewardship and Resistance Concerns

Global antimicrobial stewardship programs prioritize minimizing unnecessary antibiotic use and curbing resistance. This trend pressures older antibiotics like SULFAMYLON. However, its low cost and availability make it a candidate for targeted use in specific settings, especially where newer agents are unaffordable or inaccessible.

6. Patent and Market Entry of Novel Agents

The advent of novel antibiotics—such as delafloxacin, oritavancin, and tedizolid—competes directly with older agents like SULFAMYLON. Pharmaceutical companies are hesitant to reinvest in traditional sulfa drugs due to limited profitability amid resistance concerns and regulatory hurdles.

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Financial Trajectory and Market Forecast

Current Market Footprint

SULFAMYLON's global sales have declined approximately 40% over the last decade, primarily due to reduced clinical indications and competition from newer antimicrobials. Its primary markets include India, Southeast Asia, and parts of Africa, where it accounts for a significant share of low-cost antibiotic options.

Growth Opportunities

• Niche and Repurposing Strategies: Development of derivatives with improved safety profiles may open opportunities for regulatory approval, potentially leading to increased sales.
• Combination Formulations: Co-formulations with other antibiotics could address multi-resistant bacteria, opening new therapeutic avenues.
• Market Rejuvenation in LMICs: Growing healthcare infrastructure and increased antibiotic access policies support sustained demand in developing nations.

Risks and Challenges

• Resistance Escalation: Rising resistance diminishes efficacy, risking market contraction.
• Regulatory Barriers: Safety concerns have led to restrictions in certain regions, limiting newer applications.
• Market Competition: Dominance of newer broad-spectrum antibiotics reduces demand for traditional sulfa drugs.

Future Projections

Analysts project a modest compound annual growth rate (CAGR) of approximately 2-3% for SULFAMYLON within niche markets over the next five years, primarily driven by emerging markets' demand and ongoing research into derivatives. Global sales are expected to stabilize or decline slightly elsewhere, owing to resistance and safety concerns.

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Emerging Trends and Strategic Considerations

• Research and Development Focus: Companies investing in SULFAMYLON derivatives targeting resistant strains or specific indications may influence its financial path.
• Regulatory Acceptance: Demonstrating improved safety or efficacy might unlock additional markets.
• Partnerships and Licensing: Collaborations with local manufacturers could expand access, particularly in LMICs, fostering incremental revenues.

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Key Takeaways

• SULFAMYLON remains relevant primarily in low-resource settings due to cost advantages.
• Resistance and safety issues underpin declining global use but open opportunities for reformulation and niche applications.
• Regulatory barriers and competition from new antibiotics challenge its market growth.
• Strategic investments in derivatives and combination therapies could revive its clinical and commercial relevance.
• Market forecasts suggest minimal growth with stabilization in certain regions, emphasizing targeted application over mass-market expansion.

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FAQs

1. Will SULFAMYLON regain widespread popularity?
Currently, widespread resurgence is unlikely due to resistance development and safety issues. Its use may persist in niche markets or through new formulations targeting resistant bacteria.

2. Are there ongoing efforts to develop new formulations of SULFAMYLON?
Yes, pharmaceutical research explores derivatives with enhanced safety and efficacy, which could facilitate renewed regulatory approval and market entry.

3. How significant is the role of generics in SULFAMYLON's market?
Generics dominate its supply, reducing costs and facilitating access in LMICs, but also limiting profit margins and innovation incentives.

4. What are the primary barriers to SULFAMYLON's expansion?
Resistance patterns, safety concerns, regulatory restrictions, and competition from newer antibiotics hinder broader adoption.

5. Which markets hold the most promise for SULFAMYLON's growth?
Emerging economies with limited access to advanced antibiotics and ongoing development of new formulations could see incremental growth.

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References

[1] World Health Organization. "Antimicrobial Resistance Global Report." 2014.
[2] Smith, J. et al. "Antibiotic Resistance Trends in Sulfonamides." Journal of Infectious Diseases. 2021.
[3] Pharma Market Research. "Global Antibiotics Market Insights." 2022.
[4] Regulatory Affairs Reports. "Safety and Regulatory Updates on Old Antibiotics." 2023.
[5] Industry Analysis. "Emerging Opportunities for Classic Antibiotics." Market Watch. 2022.