Micafungin sodium - Generic Drug Details

What are the generic drug sources for micafungin sodium and what is the scope of patent protection?

Micafungin sodium is the generic ingredient in four branded drugs marketed by Apotex, Biocon Pharma, Fresenius Kabi Usa, Hikma, Jiangsu Hansoh Pharm, Meitheal, Qilu Pharm Hainan, Xellia Pharms Aps, Zydus Pharms, Astellas, Ph Health, Teva Pharms Usa Inc, and Baxter Hlthcare Corp, and is included in thirteen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Micafungin sodium has eleven patent family members in ten countries.

There are eight drug master file entries for micafungin sodium. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for micafungin sodium

International Patents:	11
US Patents:	1
Tradenames:	4
Applicants:	13
NDAs:	13
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	5
Patent Applications:	1,394
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for micafungin sodium
What excipients (inactive ingredients) are in micafungin sodium?	micafungin sodium excipients list
DailyMed Link:	micafungin sodium at DailyMed

Recent Clinical Trials for micafungin sodium

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

Sponsor	Phase
Shandong Provincial Hospital	Phase 4
Astellas Pharma China, Inc.
Seoul National University Hospital	Phase 2

See all micafungin sodium clinical trials

Generic filers with tentative approvals for MICAFUNGIN SODIUM

Applicant	Application No.	Strength	Dosage Form
		EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS
		EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for micafungin sodium

Drug Class

Echinocandin Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for micafungin sodium

J02AX	Other antimycotics for systemic use
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for MICAFUNGIN SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYCAMINE	For Injection	micafungin sodium	50 mg/vial 100 mg/vial	021506	1	2014-06-16

US Patents and Regulatory Information for micafungin sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	207344-002	May 17, 2019	AP	RX	No	No
Teva Pharms Usa Inc	MICAFUNGIN	micafungin sodium	POWDER;INTRAVENOUS	212125-001	Jul 30, 2021		DISCN	Yes	No
Apotex	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	208366-002	Nov 5, 2020		DISCN	No	No
Jiangsu Hansoh Pharm	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	213363-001	Jul 9, 2021	AP	RX	No	No

Expired US Patents for micafungin sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006

International Patents for micafungin sodium

Country	Patent Number	Title	Estimated Expiration
Spain	2972008
Japan	2020510619	ミカファンギン組成物
Denmark	3554474
World Intellectual Property Organization (WIPO)	2018112330

Supplementary Protection Certificates for micafungin sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0788511	SPC/GB08/036	United Kingdom		PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
0788511	C00788511/01	Switzerland		PRODUCT NAME: MICAFUNGIN; REGISTRATION NO/DATE: SWISSMEDIC 60724 11.07.2012
0788511	08C0028	France		PRODUCT NAME: MICAFUNGINE; REGISTRATION NO/DATE: EU/1/08/448/001-002 20080425

Market Dynamics and Financial Trajectory for Micafungin Sodium

Last updated: November 14, 2025

Introduction

Micafungin sodium is a potent antifungal agent belonging to the echinocandin class. It is primarily used to treat invasive candidiasis, esophageal candidiasis, and candidemia, predominantly in critically ill patients or immunocompromised individuals. As an intravenous medication, it plays a vital role in managing life-threatening fungal infections, especially when oral options are limited. This report examines the evolving market landscape, key drivers and challenges, and the financial trajectory shaping the future of micafungin sodium.

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Market Overview

Global Market Size and Growth Potential

The global antifungal market, valued at approximately USD 13.75 billion in 2021, is projected to grow at a compound annual growth rate (CAGR) of around 8.1% through 2030 [1]. Within this, the echinocandin segment, including micafungin sodium, accounts for an estimated 20-25% of the total market, driven by rising prevalence of invasive fungal infections (IFIs), advances in diagnostics, and expanding use of potent antifungal agents in healthcare settings.

The demand for micafungin sodium is expected to witness robust growth, especially in regions with increasing healthcare infrastructure, such as Asia-Pacific, Latin America, and the Middle East. Developed markets, such as North America and Europe, already exhibit high penetration but continue to see incremental growth driven by innovation and comprehensive fungal infection management protocols.

Market Segments and Geographies

The primary markets for micafungin include:

• Hospitals and Critical Care Units: Due to IV administration, it's predominantly used in hospital settings, especially ICU units dealing with immunocompromised patients.
• Geographical Distribution:
  • North America: Largest market share driven by high healthcare expenditure and advanced diagnostic infrastructure.
  • Europe: Considerable adoption with growing awareness and increasing fungal infection cases.
  • Asia-Pacific: Fastest-growing market attributable to increasing healthcare investments, rising incidence of fungal infections, and expanding hospital networks.
  • Latin America and Middle East: Emerging markets with increasing adoption due to expanding healthcare access.

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Market Dynamics

Key Drivers

Rising Incidence of Invasive Fungal Infections (IFIs)

The global surge in immunosuppressive therapies, chemotherapies, organ transplants, and HIV/AIDS prevalence has amplified the risk of IFIs. According to the CDC, fungal infections cause significant morbidity and mortality among immunocompromised populations, fueling demand for effective antifungal therapies like micafungin sodium.

Advancements in Diagnostics and Treatment Protocols

Rapid diagnostic tools facilitate early detection of fungal infections, prompting timely initiation of potent antifungals. Moreover, clinicians prefer drugs with favorable safety profiles and broad-spectrum efficacy, characteristics exemplified by micafungin.

Regulatory Approvals and Expanded Indications

Regulatory authorities such as the FDA and EMA have approved micafungin for various indications, reinforcing market stability. Ongoing clinical trials also explore new uses, potentially broadening its application scope.

Healthcare Infrastructure Development in Emerging Markets

Expanding healthcare infrastructure, increasing hospital admissions, and rising awareness about fungal infections support market expansion in emerging regions, notably Asia-Pacific.

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Key Challenges

High Cost and Reimbursement Barriers

Micafungin sodium's high production costs and intravenous-only formulation contribute to its premium pricing. In many low- and middle-income countries, reimbursement challenges limit accessibility.

Limited Oral Formulation

The absence of an oral form restricts outpatient use, positioning micafungin primarily as a hospital-inpatient medication, potentially limiting market penetration in outpatient settings.

Competitive Landscape

Other echinocandins, such as caspofungin and anidulafungin, compete with micafungin, offering similar efficacy. Patent expirations and generics could influence pricing pressure over time.

Emerging Resistance

While resistance to echinocandins remains relatively low, concerns about emerging fungal resistance necessitate ongoing surveillance and impact long-term demand.

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Financial Trajectory and Strategic Outlook

Revenue Trends

Leading pharmaceutical companies like Mitsubishi Tanabe Pharma and Astellas Pharma, key producers of micafungin, have reported steady revenue streams over the past five years, reflecting consistent demand from healthcare providers (e.g., Mitsubishi's core antifungal sales). However, revenue growth is expected to stabilize unless new indications are established.

Pipeline and Innovation

Current developments focus on:

• Formulation Innovations: Efforts to develop oral or redesigned formulations could expand usage beyond inpatient settings.
• Combination Therapies: Studies exploring micafungin in combination with other antifungals could improve efficacy and address resistance.
• New Indications: Investigations into prophylactic uses and treatment of other fungal pathogens could unlock new revenue streams.

Market Expansion Strategies

Producers are adopting strategies such as licensing, regional manufacturing, and collaborations to increase market share, especially in emerging economies. Price competitiveness and payer negotiations will be pivotal in expanding access.

Regulatory and Patent Outlook

The expiration of patents in some regions could lead to the entry of generic competitors, exerting downward pressure on prices but potentially increasing volume sales due to broader access.

Long-term Profitability

Despite challenges, the strategic focus on expanding indications, enhancing formulations, and penetrating emerging markets positions micafungin sodium for sustained growth. Investment in R&D and strategic partnerships will be critical to maintaining a competitive edge.

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Conclusion

The market landscape for micafungin sodium is characterized by steady growth driven by the rising burden of invasive fungal infections, advances in diagnostic technology, and expanding healthcare infrastructure across developing regions. While high costs and limited formulations pose challenges, innovation and strategic market expansion are expected to sustain its financial trajectory. The next decade may witness increased adoption bolstered by pipeline developments, regulatory approvals, and efforts to improve affordability.

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Key Takeaways

• Market Expansion: The global antifungal market's CAGR of approximately 8.1% indicates promising growth for micafungin, especially in the Asia-Pacific region.
• Demand Drivers: Rising immunosuppressive treatments and improved diagnostics are major catalysts.
• Pricing and Accessibility: High costs and IV-only formulations constrain broader outpatient and low-income country access.
• Competitive Dynamics: Patent expirations and generic entries could influence dynamics but also expand overall market volume.
• Innovation Opportunities: Developing oral formulations, combination therapies, and new indications will be crucial for sustained financial success.

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FAQs

1. What factors influence the pricing of micafungin sodium?
Pricing is influenced by manufacturing costs, patent status, market competition, regulatory approvals, and reimbursement policies. As patent protections expire and generics enter the market, prices may decline, affecting revenue streams.

2. How does resistance impact the future prospects of micafungin?
Currently, resistance to echinocandins remains relatively rare, but emerging resistant strains necessitate vigilance. Resistance development could limit drug efficacy, prompting the need for combination therapies or new agents.

3. Which regions offer the most growth opportunities for micafungin?
Emerging markets such as Asia-Pacific and Latin America present significant growth opportunities due to expanding healthcare infrastructure, increasing fungal infections, and rising medical tourism.

4. Are there ongoing pipeline developments for micafungin?
Yes. Research is focused on alternative formulations (oral), combination therapies, and expanding indications to enhance usability and market penetration.

5. How do competitive echinocandins influence micafungin’s market share?
Competing agents like caspofungin and anidulafungin have similar efficacy profiles; thus, competition often hinges on pricing, formulation, and indication scope. Market differentiation strategies are vital for maintaining market share.

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References
[1] Grand View Research. (2022). Antifungal Market Size, Share & Trends Analysis Report.