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
Radboud University	Phase 4
St. Antonius Hospital	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	021506-003	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

International Patents for MYCAMINE

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

Country	Patent Number	Title	Estimated Expiration
Japan	H05966	NEW USE OF POLYPEPTIDE COMPOUND
Luxembourg	91452
Canada	2029766
Russian Federation	2165423	ПОЛИПЕПТИДНОЕ СОЕДИНЕНИЕ, СПОСОБ ЕГО ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (POLYPEPTIDE COMPOUND, METHOD OF ITS SYNTHESIS AND PHARMACEUTICAL COMPOSITION)
European Patent Office	0486011
Norway	912347
Poland	346297

Supplementary Protection Certificates for MYCAMINE

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	91452	Luxembourg		91452, EXPIRES: 20200929
0788511	300352	Netherlands		300352, 20150929, EXPIRES: 20200928
0788511	CA 2008 00030	Denmark
0788511	SPC022/2008	Ireland		SPC022/2008: 20090219, EXPIRES: 20200928
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 the Pharmaceutical Drug: Mycamine

Last updated: July 27, 2025

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Introduction

Mycamine (micafungin sodium), an antifungal agent marketed by Astellas Pharma Inc., has established itself as an essential component in the treatment of invasive fungal infections, particularly candidiasis and Aspergillus-related diseases. As the global healthcare landscape evolves, understanding the market dynamics and financial trajectory of Mycamine is critical for stakeholders—including pharmaceutical companies, investors, and healthcare providers—aiming to navigate opportunities and anticipate challenges within the antifungal segment.

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Market Landscape and Disease Burden

The rising incidence of invasive fungal infections (IFIs), especially among immunocompromised populations such as oncology patients, organ transplant recipients, and critically ill individuals, has driven the demand for potent antifungal therapies. According to the Infectious Diseases Society of America (IDSA), IFIs contribute significantly to morbidity and mortality, compelling healthcare systems to prioritize effective antifungal treatments like echinocandins, which include Mycamine [1].

The global antifungal market is characterized by a high unmet need for broad-spectrum, safe, and resistance-averse agents. Mycamine’s broad activity against Candida and Aspergillus species positions it favorably amidst these demands. Its intravenous formulation caters primarily to hospitalized, immunocompromised populations, underpinning a steady, albeit specialized, market.

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Market Drivers

1. Growing Incidence of IFIs:
The global burden of fungal infections has intensified due to increasing immunosuppressive therapies and an aging population. The rise in hematologic malignancies and organ transplantation rates, notably in North America, Europe, and parts of Asia, sustains demand for potent antifungal agents like Mycamine [2].

2. Clinical Guidelines and Adoption:
Major clinical guidelines, such as those by IDSA and the European Society for Clinical Microbiology and Infectious Diseases (ESCMID), recommend echinocandins as first-line treatments for specific invasive candidiasis cases, bolstering Mycamine’s market relevance [3].

3. Technological Advantages:
Compared to older antifungals like amphotericin B and azoles, Mycamine offers favorable safety profiles, low toxicity, and minimal drug-drug interactions, enhancing its acceptance in clinical practice.

4. Regulatory Approvals and Expanding Indications:
Initially approved for invasive candidiasis, invasive aspergillosis, and esophageal candidiasis, Mycamine’s expanding indications and label updates contribute to sustained market penetration.

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Market Challenges

1. Competition from Other Antifungal Agents:
Other echinocandins (e.g., caspofungin, anidulafungin) and newer antifungal molecules like ibrexafungerp introduce competitive pressures. Pricing strategies, brand loyalty, and clinical efficacy influence market share dynamics.

2. Market Penetration in Emerging Economies:
Limited access, regulatory hurdles, and cost considerations impede widespread adoption of Mycamine in low- and middle-income countries, constraining growth potential.

3. Resistance Development:
Emerging fungal strains demonstrating resistance to echinocandins could threaten long-term efficacy, compelling ongoing surveillance and development efforts.

4. Price Sensitivity and Reimbursement Policies:
Healthcare payers increasingly scrutinize costs, impacting formulary inclusion and reimbursement for high-priced antifungal treatments.

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Financial Trajectory Analysis

1. Revenue Trends and Market Share
Astellas Pharma reports that Mycamine has maintained a steady revenue stream, particularly in North America and Japan, where the drug is heavily utilized. The drug’s revenues are approximately $300–400 million annually, with modest growth driven by increased adoption and expanding indications [4].

2. Geographic Expansion and Markets
European and Asian markets represent growth opportunities. The Asia-Pacific region, especially China and India, show increasing hospital-based use, though barriers related to pricing and regulatory pathways temper rapid growth.

3. Pipeline and Formulation Innovations
Efforts to develop oral formulations and combination therapies may enhance Mycamine’s utility, catering to outpatient settings and reducing hospitalization costs. Though these innovations are at early stages, they could influence future revenue streams.

4. Impact of Patent and Market Exclusivity
Mycamine’s patent protection extends until the early 2030s, offering a period of market exclusivity. Post-expiry, generic competition may erode market share and compress profit margins, necessitating lifecycle management strategies.

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Future Outlook and Strategic Considerations

Growth Opportunities:

• Indications Expansion: Trials for prophylactic use, longer-duration treatments, and broader fungal species spectrum are ongoing.
• Formulation Evolution: Developing oral or long-acting formulations could open outpatient markets, diversifying revenue sources.
• Regional Penetration: Strengthening presence in emerging markets through partnerships and local manufacturing could drive incremental growth.

Potential Risks:

• Market Saturation: The current niche market may experience saturation, limiting revenue growth without diversification.
• Competitive Innovation: Disruptive competitors or novel antifungal classes could threaten Mycamine's market position.
• Price and Reimbursement Pressures: Heightened cost-containment policies may restrict pricing strategies.

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Conclusion

Mycamine stands as a vital antifungal agent with a stable yet gradually evolving market footprint, driven by the increasing prevalence of invasive fungal infections in vulnerable patient populations. While current revenues demonstrate resilience, near-term growth hinges on geographic expansion, formulation innovations, and maintaining a competitive edge amidst rising resistance and competition. Strategic investments in pipeline development, strategic alliances, and cost-effective positioning are essential for optimizing the drug’s long-term financial trajectory.

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Key Takeaways

• The global rise in invasive fungal infections sustains steady demand for Mycamine, especially in developed healthcare markets.
• Clinical guideline endorsements and its safety profile underpin its strong market positioning.
• Competition and resistance remain significant hurdles; innovation, especially in formulations, is critical for future growth.
• Geographic expansion and regulatory approvals in emerging markets present meaningful revenue opportunities.
• Post-patent expiration, competitive pressures and generic entry could impact profitability, emphasizing the importance of lifecycle management.

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FAQs

1. What are the primary indications for Mycamine?
Mycamine is approved for invasive candidiasis, invasive aspergillosis, and esophageal candidiasis, mainly in hospitalized, immunocompromised patients.

2. How does Mycamine compare to other antifungal agents?
It offers a favorable safety profile, minimal drug interactions, and broad activity against Candida and Aspergillus species, positioning it as a preferred first-line agent in certain clinical scenarios.

3. What are the main competitive challenges facing Mycamine?
The main challenges include competition from other echinocandins, resistance development, emerging antifungal agents, and market access barriers in emerging economies.

4. Is there potential for Mycamine’s revenue growth in emerging markets?
Yes, provided regulatory pathways are navigated effectively, and pricing strategies are adapted, growth opportunities exist in regions like Asia-Pacific and Latin America.

5. What strategic measures can secure Mycamine’s long-term market position?
Investing in pipeline development, expanding indications, innovating formulations, and building strategic partnerships will be pivotal in maintaining market relevance.

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References

[1] Infectious Diseases Society of America (IDSA). "Practice Guidelines for the Diagnosis and Management of Invasive Fungal Infections." 2016.
[2] World Health Organization. "Global Epidemiology of Fungal Infections." 2020.
[3] European Society for Clinical Microbiology and Infectious Diseases (ESCMID). "Guidelines on the use of echinocandins." 2018.
[4] Astellas Pharma Inc. Annual Financial Reports. 2022.

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Note: All financial figures are approximations based on publicly available data and are subject to change with market conditions.