MAFENIDE ACETATE - Generic Drug Details

What are the generic sources for mafenide acetate and what is the scope of freedom to operate?

Mafenide acetate is the generic ingredient in two branded drugs marketed by Rising, Endo Operations, Novast Labs, and Mylan Institutional, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for mafenide acetate. Three suppliers are listed for this compound.

Summary for MAFENIDE ACETATE

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	2
Patent Applications:	1,501
Drug Prices:	Drug price trends for MAFENIDE ACETATE
What excipients (inactive ingredients) are in MAFENIDE ACETATE?	MAFENIDE ACETATE excipients list
DailyMed Link:	MAFENIDE ACETATE at DailyMed

See drug prices for MAFENIDE ACETATE

Recent Clinical Trials for MAFENIDE ACETATE

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

Sponsor	Phase
Maricopa Integrated Health System	N/A
PuriCore, Inc.	N/A
Valleywise Health	N/A

See all MAFENIDE ACETATE clinical trials

Pharmacology for MAFENIDE ACETATE

Drug Class

Methylated Sulfonamide Antibacterial

Medical Subject Heading (MeSH) Categories for MAFENIDE ACETATE

Anti-Infective Agents, Local

Anatomical Therapeutic Chemical (ATC) Classes for MAFENIDE ACETATE

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

US Patents and Regulatory Information for MAFENIDE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Institutional	SULFAMYLON	mafenide acetate	FOR SOLUTION;TOPICAL	019832-003	Jun 5, 1998		DISCN	Yes	No
Rising	SULFAMYLON	mafenide acetate	CREAM;TOPICAL	016763-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Novast Labs	MAFENIDE ACETATE	mafenide acetate	FOR SOLUTION;TOPICAL	206716-001	Jul 31, 2017		DISCN	No	No
Endo Operations	MAFENIDE ACETATE	mafenide acetate	FOR SOLUTION;TOPICAL	201511-001	Feb 12, 2013		DISCN	No	No

Expired US Patents for MAFENIDE ACETATE

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

MAFENIDE ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mafenide Acetate

Introduction to Mafenide Acetate

Mafenide acetate is a topical antimicrobial agent widely used in the treatment of burn wounds and other skin infections. Its efficacy in reducing bacterial load and preventing infections makes it a crucial component in burn care.

Market Drivers

The market for mafenide acetate, as part of the broader topical drugs market, is driven by several key factors:

Increasing Prevalence of Skin Disorders and Infections

The rising incidence of skin infections, such as psoriasis, atopic dermatitis, and eczema, significantly contributes to the demand for topical treatments like mafenide acetate. For instance, the prevalence of psoriasis is nearly 1.92% and 1.5% among European and North American populations, respectively[1].

High Incidence of Burn Injuries

Burn injuries are another major driver. According to the WHO, an estimated 11 million burn injuries occur annually worldwide, with about 180,000 cases being fatal. Mafenide acetate is a critical treatment for these injuries[1].

Technological Advancements and Strategic Collaborations

Advancements in delivery technologies, such as the acquisition of AcuStream technology by Novartis AG, enhance the efficacy and accuracy of dermal drug delivery. Strategic collaborations and acquisitions among key players also boost the market's growth[1].

Market Restraints

While mafenide acetate has several benefits, there are also some restraints to consider:

Cost and Efficacy Concerns

Historically, the 5% mafenide acetate solution has been more commonly used but is also more expensive. Studies have shown that a 2.5% solution can be equally efficacious and significantly more cost-effective, which might influence market dynamics and pricing strategies[2][3].

Regulatory Framework

The regulatory environment can impact the market. For example, mafenide acetate has been approved since 1969, but changes in regulatory policies or the introduction of new drugs could affect its market share[4].

Financial Trajectory

Cost-Effectiveness of Different Concentrations

The financial trajectory of mafenide acetate is significantly influenced by its cost-effectiveness. Studies have demonstrated that switching from a 5% to a 2.5% solution can reduce costs substantially without compromising patient outcomes. For instance, the mean cost of 2.5% mafenide acetate therapy was $1494.92 compared to $3741.39 for the 5% solution[3].

Market Size and Growth

The global topical drugs market, which includes mafenide acetate, is expected to reach USD 217.79 billion by 2030, growing at a CAGR of 10.1% from 2022 to 2030. This growth indicates a robust financial trajectory for topical treatments, including mafenide acetate[1].

Revenue Impact of Strategic Initiatives

Strategic initiatives such as new product launches, mergers, and acquisitions can significantly impact the revenue of companies involved in the production and distribution of mafenide acetate. For example, Novartis AG's acquisition of Kedalion Therapeutics and Alcon Inc.'s acquisition of Eysuvis have expanded their portfolios and potentially increased their market share[1].

Segment Analysis

By Type

The semi-solid formulations segment, which includes creams and ointments like mafenide acetate, dominated the market in 2021 due to their high stability and increased use in personalized medicine[1].

By Route of Administration

The dermal segment, which includes transdermal patches and topical creams, dominated the industry in 2021. Mafenide acetate falls under this category, given its primary use as a topical treatment for burn wounds[1].

By End-use

The home care settings segment dominated the industry in 2021 due to the ease of administration, particularly among the geriatric population. However, burn centers and hospitals also play a significant role in the use of mafenide acetate[1].

Regional Market Analysis

North America was the largest regional market in 2021, driven by strategic initiatives and collaborations among key players for the development and launch of dermal products. This region is likely to continue driving the demand for mafenide acetate due to its advanced healthcare infrastructure and high incidence of burn injuries[1].

Competitive Landscape

The competitive landscape for mafenide acetate involves several key players, including Bayer AG, Cipla, Inc., GSK Group of Companies, Johnson & Johnson Private Limited, and Novartis AG. These companies engage in various strategies such as new product launches, mergers, and acquisitions to maintain and expand their market share[1].

Key Takeaways

• Growing Demand: The increasing prevalence of skin disorders and burn injuries drives the demand for mafenide acetate.
• Cost-Effectiveness: The 2.5% concentration of mafenide acetate is a cost-effective alternative to the 5% solution without compromising efficacy.
• Market Growth: The global topical drugs market is expected to grow significantly, with mafenide acetate being a key component.
• Strategic Initiatives: Acquisitions and collaborations among key players enhance the market's growth and the financial trajectory of mafenide acetate.
• Regional Dominance: North America leads the market due to advanced healthcare infrastructure and strategic initiatives.

FAQs

1. What is the primary use of mafenide acetate? Mafenide acetate is primarily used as a topical antimicrobial agent to treat burn wounds and reduce bacterial load.

2. How does the concentration of mafenide acetate affect its cost and efficacy? Studies have shown that a 2.5% solution of mafenide acetate is equally efficacious as the 5% solution but significantly more cost-effective, reducing costs by nearly 60% without compromising patient outcomes[2][3].

3. What are the key drivers of the market for mafenide acetate? The market is driven by the increasing prevalence of skin disorders, high incidence of burn injuries, technological advancements, and strategic collaborations among key players[1].

4. Which region dominates the market for topical drugs, including mafenide acetate? North America is the largest regional market due to its advanced healthcare infrastructure and strategic initiatives among key players[1].

5. How is the financial trajectory of mafenide acetate expected to evolve? The financial trajectory is expected to be robust, driven by the growing demand for topical treatments and the cost-effectiveness of the 2.5% concentration, along with strategic initiatives and market growth[1].

Cited Sources

1. ResearchAndMarkets.com: Global Topical Drugs Market Size, Share & Trends Analysis Report by Type, by Route Of Administration, by End-use, by Region, and Segment Forecasts, 2022-2030[1].
2. PubMed: A simple cost-saving measure: 2.5% mafenide acetate solution[2].
3. PubMed: 2.5% Mafenide Acetate: A Cost-Effective Alternative to the 5% Formulation[3].
4. Synapse: Mafenide Acetate - Drug Targets, Indications, Patents[4].