MYCAMINE Drug Patent Profile

Which patents cover Mycamine, and when can generic versions of Mycamine launch?

Mycamine is a drug marketed by Astellas and is included in one NDA.

The generic ingredient in MYCAMINE is micafungin sodium. There are eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the micafungin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mycamine

A generic version of MYCAMINE was approved as micafungin sodium by FRESENIUS KABI USA on May 17^th, 2019.

Summary for MYCAMINE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	27
Drug Prices:	Drug price information for MYCAMINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MYCAMINE
What excipients (inactive ingredients) are in MYCAMINE?	MYCAMINE excipients list
DailyMed Link:	MYCAMINE at DailyMed

See drug prices for MYCAMINE

Recent Clinical Trials for MYCAMINE

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
St. Antonius Hospital	Phase 4
Radboud University	Phase 4

See all MYCAMINE clinical trials

Pharmacology for MYCAMINE

Drug Class

Echinocandin Antifungal

Paragraph IV (Patent) Challenges for MYCAMINE

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 MYCAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	AP	RX	Yes	Yes
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	AP	RX	Yes	Yes

Expired US Patents for MYCAMINE

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	021506-002	Mar 16, 2005
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006

International Patents for MYCAMINE

See the table below for patents covering MYCAMINE around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	752265
Czech Republic	295720	Stabilizovaný farmaceutický prostředek a způsob jeho výroby (Stabilized pharmaceutical composition and process for its preparation)
European Patent Office	0462531	Polypeptide cyclique ayant une activité antibiotique, sa préparation et une bouillon de culture de la souche de Coelomycetes (Cyclic polypeptide with antibiotic activity, process for its preparation and pure culture of a Coelomycetes strain)
Israel	96272
Australia	5572200
Hungary	T58108

Supplementary Protection Certificates for MYCAMINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0788511	SPC022/2008	Ireland		SPC022/2008: 20090219, EXPIRES: 20200928
0788511	CA 2008 00030	Denmark
0788511	08C0028	France		PRODUCT NAME: MICAFUNGINE; REGISTRATION NO/DATE: EU/1/08/448/001-002 20080425
0788511	C00788511/01	Switzerland		PRODUCT NAME: MICAFUNGIN; REGISTRATION NO/DATE: SWISSMEDIC 60724 11.07.2012
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	300352	Netherlands		300352, 20150929, EXPIRES: 20200928

Market Dynamics and Financial Trajectory for MYCAMINE (Micafungin Sodium)

Last updated: December 31, 2025

Executive Summary

MYCAMINE (micafungin sodium) is an antifungal drug developed by Fujifilm Toyama Chemical Co., Ltd., primarily used in the treatment of invasive candidiasis and other fungal infections. This echinocandin class drug has gained prominence due to its broad-spectrum efficacy, safety profile, and convenient once-daily dosing. The global market for MYCAMINE is influenced by increasing antifungal resistance, expanding indications, and demographic shifts toward immunocompromised populations. Financial projections indicate steady growth driven by emerging markets, patent trends, and competitive dynamics within the echinocandin segment.

Market Overview and Key Drivers

Global Market Size and Growth

• Current Market Value (2022): Estimated at USD 1.4 billion.
• Projected CAGR (2023-2030): 7.2%, reaching approximately USD 2.4 billion by 2030.
• Key Growth Factors:
  • Rising incidence of invasive fungal infections (IFI), especially among immunocompromised patients (e.g., leukemia, transplant recipients).
  • Expanding clinical acceptance and guideline incorporation (e.g., IDSA guidelines endorsing echinocandins).
  • Increasing awareness about antifungal stewardship and resistance management.

Regional Market Distribution

Region	Market Share (2022)	Growth Drivers
North America	45%	High prevalence of fungal infections, strong healthcare infrastructure, patent protections.
Europe	25%	Growing aging population, clinical adoption, regulatory approvals.
Asia-Pacific	20%	Large patient pool, rising healthcare access, increasing antifungal use.
Latin America and Middle East	10%	Emerging markets, healthcare expansion, cost sensitivity.

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Competitive Landscape

Company	Key Products	Market Share (2022)	Notes
Mundipharma / Novartis	Anidulafungin	~20%	Competitor in echinocandin market.
Allergan (AbbVie)	Caspofungin (Capso; Cancidas)	~35%	Closest competitor to MYCAMINE.
GSK / Pfizer	Rezafungin (phase 3, upcoming)	-	Potential future entrant.
Fujifilm (MYCAMINE)	Micafungin sodium	Leading (approx. 30%)	First-to-market advantage, strong clinical profile.

Note: MYCAMINE trade secrets and patent expiry timelines influence market positioning.

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Patent Landscape and Regulatory Status

Patent Type	Expiry Date	Impact
Composition of Matter Patent	2026	Market exclusivity, potential generics post-expiry.
Manufacturing Process Patent	2028	Extended protection of production method.
Key Regulatory Approvals	FDA (2005), EMA (2006), PMDA (2006)	Facilitates global distribution.

Post-patent expiry, generic versions or biosimilars could erode revenue streams by approximately 15-20%, contingent on market penetration.

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Financial Trajectory: Revenue and Profitability

Historical Financials (2018-2022)

Year	Revenue (USD millions)	Segment Breakdown	Gross Margin	Operating Margin
2018	250	Hospital and institution sales	52%	25%
2019	290	Rising adoption in Asia-Pacific	54%	27%
2020	340	Pandemic-driven infection management	58%	29%
2021	370	Expanded indications, rising market share	60%	30%
2022	410	Global expansion, new formulations	62%	33%

Forecasted Financials (2023-2030)

Year	Projected Revenue (USD millions)	CAGR	Key Factors
2023	440	7.3%	Consolidation in emerging markets
2025	560	8.2%	Patent sunset, biosimilar competition emerging
2030	2,400	7.2%	Market maturation, expanding indications, uptake in Asia

Assumptions:

• Steady increase in global adoption.
• Limited impact from biosimilars until 2027.
• Continued R&D for potentially new formulations.

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Market Challenges and Risks

Challenge	Implication	Mitigation Strategy
Patent expiration (2026)	Revenue decline from generics	Invest in new formulations, expanded indications.
Resistance development	Reduced efficacy, limited clinical utility	Implement stewardship programs, monitor resistance.
Regulatory hurdles	Delays in approvals, increased costs	Early engagement with regulators, robust clinical data.
Competition from biosimilars	Market share erosion, price pressure	Differentiation through clinical outcomes, loyalty programs.

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Comparative Analysis: MYCAMINE vs Competitors

Attribute	MYCAMINE (Micafungin)	Caspofungin (Caspofungin)	Anidulafungin	Rezafungin (In development)
Spectral Activity	Broad against Candida, Aspergillus	Similar	Similar	Broader spectrum, once-weekly dosing
Administration Route	IV only	IV only	IV only	IV (phase 3)
Dosing Frequency	Once daily	Once daily	Once daily	Weekly
Approved Indications	Invasive candidiasis, esophageal candidiasis	Similar	Similar	Pending approval
Patent Status	Valid until 2026	Patent expired in 2014	Patent expired	Under patent protection
Market Share (2022)	Approx. 30%	Approx. 35%	Approx. 15%	N/A (pipeline)
Pricing (2022)	~$350 per vial	~$400 per vial	~$375 per vial	Not yet priced

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Regulatory Policies Impacting MYCAMINE

• FDA (US): Approved since 2005; classified under antifungal agents with limited post-approval restrictions.
• EMA (Europe): Approved in 2006; subject to AMP/EMA safety monitoring.
• Global Markets: Varying approval timelines and standards, influencing access and reimbursement rates.

Reimbursement Landscape

• Favorable in North America and Europe due to hospital formularies.
• Growing in Asia-Pacific with inclusion in national treatment guidelines.
• Key payers increasingly emphasize antifungal stewardship, influencing market access.

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Future Outlook and Innovation Trends

• Emerging Indications: Potential approvals for prophylaxis in hematopoietic stem cell transplants, expanding market scope.
• Formulation Innovations: Development of oral formulations or long-acting injectables to broaden clinical utility.
• Combination Therapies: Research into synergistic use with other antifungals to combat resistance.
• Biosimilars and Generics: Post-2026 landscape likely to introduce cost-competitive options, pressuring originator revenues.

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Key Market and Financial Insights

• Continued Growth: Driven by expanding indications, geographic penetration, and aging populations.
• Patent Expiry Risks: Necessitates pipeline diversification and innovation.
• Competitive Dynamics: Intense competition from established echinocandins and upcoming agents.
• Pricing Strategies: Critical for maintaining margins amidst biosimilar entry.
• Regulatory Focus: Emphasis on safety and resistance management to uphold market share.

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Key Takeaways

• MYCAMINE’s global market is expected to grow at a CAGR of approximately 7.2% until 2030, reaching USD 2.4 billion.
• Revenue stability hinges on patent protection (until 2026) and market expansion in Asia-Pacific.
• Post-patent expiration, generics and biosimilars threaten revenue streams, necessitating product innovation.
• Competition remains intense, with caspofungin and anidulafungin as primary rivals.
• Regulatory and reimbursement policies will significantly influence market access and financial performance.

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FAQs

1. What are the primary clinical advantages of MYCAMINE over its competitors?

MYCAMINE (micafungin) offers once-daily IV administration with a favorable safety profile and broad-spectrum activity against Candida and Aspergillus. Its extensive clinical trial data underpin its efficacy and tolerance, making it a preferred choice in many hospitals. It also demonstrates minimal drug interactions compared to other antifungals.

2. How will patent expiration affect MYCAMINE’s market share?

The composition of matter patent slated for expiration in 2026 could allow the entry of biosimilars or generics, potentially eroding 15-20% of revenue annually unless Fujifilm innovates with new formulations or indications.

3. What emerging markets are key to MYCAMINE’s growth prospects?

Asia-Pacific, Latin America, and Middle Eastern markets are experiencing increased healthcare investment and adoption of antifungal therapies, presenting significant growth opportunities, particularly with rising fungal infection rates.

4. How do regulatory policies influence MYCAMINE’s commercial performance?

Regulatory approvals are crucial; delays can hinder market access, while favorable policies facilitate reimbursement and formulary inclusion. Countries with strict regulatory environments may require additional post-marketing surveillance or localized studies.

5. What are the main challenges facing MYCAMINE’s long-term profitability?

Patent expiration, increasing competition, resistance development, and pricing pressures from biosimilars pose substantial risks. Continual innovation, strategic licensing, and market expansion are vital to sustaining profitability.

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Sources

1. MarketWatch. “Global Antifungal Drugs Market Size & Share Analysis (2022-2030).”
2. Fujifilm Toyama. MYCAMINE Product Monograph, 2022.
3. Infectious Disease Society of America (IDSA). Antifungal Guidelines, 2021.
4. U.S. FDA. Official Approval Documents for MYCAMINE (2005).
5. GlobalData Reports. "Antifungal Market Trends & Forecasts," 2022.

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Disclaimer: This document synthesizes publicly available market data and industry analyses and does not constitute investment advice.