MUPIROCIN - Generic Drug Details

What are the generic drug sources for mupirocin and what is the scope of freedom to operate?

Mupirocin is the generic ingredient in three branded drugs marketed by Glaxosmithkline, Padagis Us, Fougera Pharms, Glenmark Pharms, Padagis Israel, Taro, Teva, Alembic, Amneal, Encube, and Glenmark Pharms Inc, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for mupirocin. Twenty-one suppliers are listed for this compound.

Summary for MUPIROCIN

US Patents:	0
Tradenames:	3
Applicants:	11
NDAs:	15
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	82
Patent Applications:	6,250
Drug Prices:	Drug price trends for MUPIROCIN
Drug Sales Revenues:	Drug sales revenues for MUPIROCIN
What excipients (inactive ingredients) are in MUPIROCIN?	MUPIROCIN excipients list
DailyMed Link:	MUPIROCIN at DailyMed

See drug prices for MUPIROCIN

See drug sales revenues for MUPIROCIN

Recent Clinical Trials for MUPIROCIN

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

Sponsor	Phase
Victoriano Luna Medical Center	Early Phase 1
Jiangxi Provincial Cancer Hospital	Phase 3
Future University in Egypt	Phase 2/Phase 3

See all MUPIROCIN clinical trials

Pharmacology for MUPIROCIN

Drug Class	RNA Synthetase Inhibitor Antibacterial
Mechanism of Action	RNA Synthetase Inhibitors

Medical Subject Heading (MeSH) Categories for MUPIROCIN

Anti-Bacterial Agents

Protein Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for MUPIROCIN

D06AX	Other antibiotics for topical use
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

R01AX	Other nasal preparations
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

US Patents and Regulatory Information for MUPIROCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	MUPIROCIN	mupirocin	OINTMENT;TOPICAL	065170-001	Sep 23, 2005	AB	RX	No	No
Padagis Israel	MUPIROCIN	mupirocin calcium	CREAM;TOPICAL	212465-001	Aug 3, 2022		DISCN	No	No
Taro	MUPIROCIN	mupirocin calcium	CREAM;TOPICAL	207116-001	Apr 27, 2020	AB	RX	No	No
Padagis Us	CENTANY	mupirocin	OINTMENT;TOPICAL	050788-001	Dec 4, 2002	BX	RX	No	No
Fougera Pharms	MUPIROCIN	mupirocin	OINTMENT;TOPICAL	065192-001	Nov 30, 2005	AB	RX	No	No
Glenmark Pharms Inc	MUPIROCIN	mupirocin calcium	CREAM;TOPICAL	201587-001	Jan 24, 2013	AB	RX	No	Yes
Amneal	MUPIROCIN	mupirocin calcium	CREAM;TOPICAL	214811-001	Nov 15, 2022	AB	RX	No	No

Expired US Patents for MUPIROCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Padagis Us	CENTANY	mupirocin	OINTMENT;TOPICAL	050788-001	Dec 4, 2002	6,013,657

MUPIROCIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mupirocin

Introduction to Mupirocin

Mupirocin is a topical antibiotic widely used for treating bacterial skin infections. Its effectiveness and broad application in dermatology and wound care have made it a significant player in the pharmaceutical market.

Market Growth and Projections

The Mupirocin Ointment Market has experienced substantial growth in recent years and is projected to continue this upward trend from 2023 to 2031. Here are some key points:

• Global Expansion: The market is expected to see significant expansion, driven by rising instances of bacterial skin infections and increasing awareness of the product's efficacy[4].
• Regional Dominance: North America leads the market due to its robust healthcare infrastructure and high prevalence of skin infections. Europe and the Asia-Pacific region also show substantial demand, driven by growing emphasis on skincare and expanding healthcare access[4].

Market Segmentation

The Mupirocin Ointment Market is segmented based on several factors:

• Type: The market is categorized into different types such as 5 grams, 15 grams, 22 grams, and others[3].
• Application: Key applications include hospitals, clinics, retail pharmacies, and other healthcare settings[3].
• Geographical Regions: The market is analyzed across North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[3].

Drivers of Market Growth

Several factors are driving the growth of the Mupirocin Ointment Market:

• Rising Incidence of Skin Infections: The increasing number of bacterial skin infections globally is a significant growth catalyst[4].
• Increasing Awareness: Growing awareness among healthcare providers and patients about the effectiveness of Mupirocin ointment has driven its demand[4].
• Expansion of Healthcare Infrastructure: Particularly in emerging markets, the widening access to healthcare services has expanded the market's reach[4].
• Research and Development: Continuous investment by key market players in R&D has led to the introduction of advanced formulations, further fueling market growth[4].

Restraints and Challenges

Despite the promising growth, the Mupirocin Ointment Market faces several challenges:

• Antibiotic Resistance: The emergence of antibiotic resistance can reduce the product's effectiveness over time[4].
• Regulatory Hurdles: Stringent quality standards and regulatory hurdles in some regions can pose barriers to market expansion[4].

Financial Trajectory

The financial performance of the Mupirocin market is robust and shows promising growth:

• Revenue Projections: The market is expected to see significant revenue growth from 2023 to 2031, with projections indicating strong growth rates[3][5].
• Market Size: The global Mupirocin Ointment Market is valued in USD millions and is expected to increase substantially over the forecast period[3][5].

Key Players and Market Strategies

Key players in the Mupirocin market are adopting various strategies to maintain and expand their market share:

• Biofrontera AG: For example, Biofrontera AG, with its product Xepi™, aims to achieve broader market penetration and better clinical results than competitors. The company targets significant revenue growth, with projections between EUR 200 million and EUR 400 million by 2025[2].
• Market Access: Companies are focusing on optimizing market access through unrestricted insurance coverage, copay card programs, and distribution through independent community pharmacies[2].

Regional Market Potential

• North America: This region dominates the market due to its advanced healthcare infrastructure and high prevalence of skin infections. For instance, Biofrontera AG's product Ameluz® has seen significant sales in the US, with over 95,000 tubes sold in 2020[2].
• Europe: European markets exhibit substantial demand driven by the growing emphasis on skincare and dermatological treatments. Regulatory compliance and stringent quality standards are key characteristics of this region[4].
• Asia-Pacific: Emerging economies in this region are witnessing rapid growth due to increasing awareness of the product's efficacy and expanding access to healthcare services[4].

Product Variations and Pricing

The market offers various product variations, including different tube sizes and formulations:

• Mupirocin Calcium 2 Cream: This product is expected to grow at a CAGR of 3 to 5 percent from 2023 to 2031, with pricing strategies playing a crucial role in market dynamics[5].
• Pricing Strategies: For example, Xepi™ is priced at $297 per tube, with a goal to sell between 200,000 to 300,000 tubes by 2025[2].

Competitive Landscape

The competitive landscape of the Mupirocin Ointment Market is dynamic:

• Generic Mupirocin: Generic versions of Mupirocin compete with branded products, with a CAGR of 4% observed in recent years[2].
• Competitor Analysis: Companies like Biofrontera AG are focusing on achieving broader labels and better clinical results than competitors to gain a competitive edge[2].

Research and Development

Continuous investment in R&D is crucial for market growth:

• Indication Expansions: Companies are focusing on expanding the indications for their products, such as Biofrontera AG's efforts to launch new indications for Ameluz®[2].
• Advanced Formulations: The introduction of advanced formulations has further fueled market growth, as these innovations address emerging needs in dermatology and wound care[4].

Market Access and Distribution

Market access and distribution strategies are vital for the success of Mupirocin ointment:

• Insurance Coverage: Over 150 million lives are covered by unrestricted access to Xepi™, with a redesigned copay card program to improve profitability and minimize patient abandonment[2].
• Distribution Channels: Independent community pharmacies and alternate distributors in underserved areas are being utilized to enhance market reach[2].

Key Takeaways

• The Mupirocin Ointment Market is poised for significant growth from 2023 to 2031.
• Rising skin infections, increasing awareness, and expanding healthcare infrastructure are key drivers.
• Antibiotic resistance and regulatory hurdles are significant challenges.
• Key players are focusing on R&D, market access, and competitive strategies to drive growth.
• Regional markets, especially North America and the Asia-Pacific, show promising growth potential.

FAQs

Q: What are the primary drivers of the Mupirocin Ointment Market? A: The primary drivers include the rising incidence of bacterial skin infections, increasing awareness of the product's efficacy, and the expansion of healthcare infrastructure in emerging markets[4].

Q: Which region dominates the Mupirocin Ointment Market? A: North America dominates the market due to its robust healthcare infrastructure and high prevalence of skin infections[4].

Q: What are the challenges faced by the Mupirocin Ointment Market? A: The market faces challenges such as the emergence of antibiotic resistance and regulatory hurdles in some regions[4].

Q: How are key players strategizing to maintain market share? A: Key players are focusing on R&D, optimizing market access, and achieving broader labels and better clinical results than competitors[2].

Q: What is the projected growth rate of the Mupirocin Ointment Market? A: The market is expected to see strong growth rates from 2023 to 2031, with projections indicating sustained significant expansion[3][5].

Cited Sources

1. Market Research Intellect: Global Topical Mupirocin Ointment Market Size, Trends and ...
2. Biofrontera: Investor Presentation - Biofrontera
3. Market Research Intellect: Global Mupirocin Ointment Market Size, Scope And Forecast Report
4. OpenPR: Mupirocin Ointment Market: Driving Factors and Market Trends 2024
5. Market Research Intellect: Mupirocin Calcium 2 Cream Market Size And Forecast