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. Three suppliers are 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:	105
Clinical Trials:	2
Patent Applications:	3,949
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

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
Netherlands	6704087
Belgium	695694
United Kingdom	1145193

SULFAMYLON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SULFAMYLON

Introduction to SULFAMYLON

SULFAMYLON, also known as mafenide acetate, is a topical antibiotic used primarily in the treatment of burn wounds. It is indicated for controlling bacterial infections in meshed autografts on excised burn wounds.

Market Segment and Growth Drivers

Topical Drug Delivery Market Context

The global topical drug delivery market, which includes products like SULFAMYLON, is projected to grow significantly. By 2027, this market is expected to reach $317.8 billion, growing at a CAGR of 8.9% from 2022 to 2027[1].

Specific Drivers for SULFAMYLON

• High Incidence of Burn Injuries: The increasing number of burn injuries globally is a major driver for the demand of topical antibiotics like SULFAMYLON. These injuries often require effective antimicrobial treatments to prevent infection and promote healing[1].
• Advancements in Transdermal Drug Delivery: Improvements in transdermal drug delivery systems enhance the efficacy and convenience of products like SULFAMYLON, contributing to their market growth[1].

Market Trends and Segmentation

Facility of Use

The home care settings segment dominates the topical drug delivery market, including products like SULFAMYLON. This is due to the convenience, better medical adherence, and improved treatment outcomes associated with home care[1].

Geographical Distribution

North America holds the largest share of the global topical drug delivery market, driven by the rising prevalence of target health conditions, preference for pain-free drug delivery solutions, and advancements in transdermal patches[1].

Product Characteristics and Usage

Mechanism of Action

SULFAMYLON exerts broad bacteriostatic action against many gram-negative and gram-positive organisms, including Pseudomonas aeruginosa. Its mechanism of action is distinct from sulfonamides and is not altered by environmental acidity[3].

Clinical Use

SULFAMYLON is used as an adjunctive topical antimicrobial agent under moist dressings over meshed autografts on excised burn wounds. It has been shown to effectively control bacterial infections and promote wound healing[3].

Financial Trajectory

Market Size and Growth

While the specific financial data for SULFAMYLON is not isolated from the broader topical drug delivery market, the overall market's growth trajectory indicates a significant increase in revenue. The global topical drug delivery market was valued at $207.4 billion in 2022 and is expected to reach $317.8 billion by 2027[1].

Revenue Contribution

Given its niche but critical role in burn wound treatment, SULFAMYLON contributes to the revenue growth within the topical antibiotics segment. The demand for effective topical antimicrobials, especially in burn care, drives the financial performance of such products.

Challenges and Restraints

Adverse Reactions and Contraindications

SULFAMYLON can cause adverse reactions such as rash, itching, and in severe cases, fatal hemolytic anemia. It is contraindicated in patients hypersensitive to mafenide acetate, which can act as a restraint on its market growth[3].

Continuous Irritation and Allergies

Topical drugs, including SULFAMYLON, can cause continuous irritation and allergies, which are significant restraints in the broader topical drug delivery market[1].

Clinical Efficacy and Impact

Efficacy in Burn Wounds

Studies have shown that SULFAMYLON is highly effective in controlling bacterial infections in burn wounds. For example, a study demonstrated that SULFAMYLON solution eradicated bacterial loads and promoted interstitial closure rates in contaminated meshed skin grafts[2].

Patient Outcomes

The use of SULFAMYLON can significantly improve patient outcomes by reducing the risk of infection and promoting faster wound healing. This enhances the overall quality of care and patient satisfaction.

Regulatory and Availability Status

Generic Availability

The SULFAMYLON brand name has been discontinued in the U.S., but generic versions of mafenide acetate may be available, subject to FDA approval[3].

Key Takeaways

• Market Growth: The topical drug delivery market, including products like SULFAMYLON, is expected to grow at a CAGR of 8.9% from 2022 to 2027.
• Drivers: High incidence of burn injuries and advancements in transdermal drug delivery systems are key drivers.
• Challenges: Adverse reactions, contraindications, and continuous irritation are significant restraints.
• Clinical Efficacy: SULFAMYLON is highly effective in controlling bacterial infections in burn wounds.
• Geographical Dominance: North America holds the largest share of the global market.

FAQs

Q: What is the primary use of SULFAMYLON? A: SULFAMYLON is used as a topical antimicrobial agent to control bacterial infections in meshed autografts on excised burn wounds.

Q: What are the key drivers for the growth of the topical drug delivery market? A: High incidence of burn injuries, increasing number of smokers, growing prevalence of diabetes, and advancements in transdermal drug delivery systems.

Q: What are the potential adverse reactions associated with SULFAMYLON? A: Adverse reactions include rash, itching, and in severe cases, fatal hemolytic anemia.

Q: Is SULFAMYLON available under a brand name in the U.S.? A: No, the SULFAMYLON brand name has been discontinued in the U.S., but generic versions may be available.

Q: How effective is SULFAMYLON in treating burn wounds? A: SULFAMYLON is highly effective in controlling bacterial infections and promoting wound healing in burn patients.

Cited Sources

1. MarketsandMarkets, "Topical Drug Delivery Market Growth, Drivers, and Opportunities"
2. PubMed, "The efficacy of 5% Sulfamylon solution for the treatment of contaminated explanted human meshed skin grafts"
3. Drugs.com, "Sulfamylon: Package Insert / Prescribing Information"
4. Synapse, "Mafenide Acetate - Drug Targets, Indications, Patents"
5. Department of the Army, "UNCLASSIFIED Supporting Data FY 2001 Budget Estimate"