SULFAMYLON Drug Patent Profile

When do Sulfamylon patents expire, 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

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

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
France	6287
Netherlands	6704087

SULFAMYLON Market Analysis and Financial Projection

Last updated: February 11, 2026

What Is the Market Outlook for SULFAMYLON?

SULFAMYLON, marketed under the brand names such as Sulfadiazine and Sulfamerazine, is a sulfonamide antibiotic primarily used for bacterial infections. Its use has declined in regions with contemporary antibiotics but persists due to specific indications and geographic factors. The global antibiotic market is forecasted to reach $50.4 billion by 2028, with sulfonamides accounting for a minor segment due to competition from newer drugs.

In the United States, SULFAMYLON's application remains limited due to regulatory restrictions and resistance issues. Conversely, in developing markets, especially parts of Africa, Asia, and Latin America, there is ongoing demand driven by affordability and existing supply chains.

Key data points:

• Global antibiotic market (2023): $38 billion; expected CAGR 3.9% through 2028 [1].
• Sulfonamide segment share: Approx. 3% of total antibiotics.
• Regional demand: Higher in Africa and Southeast Asia due to limited access to advanced antibiotics.

The patent landscape for SULFAMYLON is virtually non-existent; generic manufacture prevails, and regulatory barriers vary by country.

How Do the Fundamentals of SULFAMYLON Support Investment Decisions?

Production and Patent Status

SULFAMYLON has long-standing patent expirations; it is produced generically by multiple manufacturers. Patent expirations remove exclusivity, limiting revenue potential, but low barriers to entry foster steady supply.

Regulatory Environment

In the U.S., the FDA classifies SULFAMYLON as a drug requiring careful oversight due to ADRs (Adverse Drug Reactions). It is approved for specific indications like certain Toxoplasmosis and bacterial conjunctivitis. Regulatory hurdles in developed markets inhibit expansion but do not eliminate basic use in emerging economies.

In some EU nations, the drug is off-market or restricted owing to resistance concerns and updated therapeutic guidelines.

Resistance and Efficacy

Resistance to sulfonamides has risen globally, particularly in urinary tract infections. The CDC classifies sulfonamide resistance as a significant concern, affecting the drug’s future utility as a first-line therapy.

Manufacturing and Supply Chain Dynamics

SULFAMYLON's manufacturing cost is low, estimated at below $0.10 per dose for generics. Supply chains are established in low-cost manufacturing markets, with no significant supply shortages reported.

Competitive Landscape

The presence of numerous newer antibiotics (e.g., trimethoprim-sulfamethoxazole, fluoroquinolones) reduces SULFAMYLON’s market share. Despite this, its low cost and proven efficacy in select indications sustain niche demand.

Investment Risks and Opportunities

Risks include antibiotic resistance, regulatory restrictions, and declining market share. Opportunities focus on unmet needs in specific regions with limited access to advanced antibiotics and opportunities to develop combination therapies for enhanced efficacy.

What Are the Key Financial and Strategic Considerations?

Aspect	Details	Implication
Revenue potential	Limited in developed markets; steady in low-income regions	Focus on generic manufacturing and distribution in emerging markets
R&D investment	Minimal; no current proprietary development	Cost-effective, but limited upside unless combining with novel agents
Market expansion	Restricted by resistance and regulatory constraints	Entry feasible mainly in underserved regions
Pricing and reimbursement	Competitive, low-cost environment	Marginal profit margins, requiring high volume

How Should Investors Approach SULFAMYLON?

Investors should consider the drug as part of broader antibiotic portfolios targeting low-income markets. The low manufacturing costs and existing supply chains offer steady cash flows. However, diminishing market share in advanced economies and resistance trends impose limitations.

The strategic value lies in geographic diversification and potential developments in combination therapies or new formulations that could extend utility.

Key Takeaways

• SULFAMYLON remains relevant mainly in low-income countries with limited access to newer antibiotics.
• The global antibiotic market grows modestly, with sulfonamides comprising a small segment.
• Resistance and regulatory restrictions challenge growth prospects in developed markets.
• Generics dominate production, keeping costs low and margins compressed.
• Opportunities exist in niche markets where regulatory and resistance issues are less impactful.

Frequently Asked Questions (FAQs)

1. Is there ongoing research or development related to SULFAMYLON?
Current research involves combination therapies or reformulations to overcome resistance and improve efficacy; however, no significant clinical innovation is underway for SULFAMYLON itself.

2. How does resistance impact its use?
Resistance limits effectiveness against common bacterial pathogens, reducing its prescription in many regions and constraining market growth.

3. What regulatory hurdles exist for SULFAMYLON?
Restrictions stem from safety concerns, observed ADRs, and resistance issues, leading some countries to phase out or restrict its use.

4. Are there opportunities for biosimilars or new formulations?
No, since SULFAMYLON is a small molecule generic, biosimilars are not applicable. Reformulation opportunities are limited and unlikely to significantly alter the landscape.

5. What are the main markets for SULFAMYLON today?
Primary markets include low-income countries in Africa, Asia, and Latin America, where affordability and existing supply chains sustain demand.

---

References

1. Data on antibiotic market size and growth projections from [1] Statista, 2023.