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, Hisun Pharm Hangzhou, 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 fourteen 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. Twelve 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:	14
NDAs:	14
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	12
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 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS
		EQ 50MG 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
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005		DISCN	Yes	No
Xellia Pharms Aps	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	211713-001	Jun 2, 2021	AP	RX	No	No
Hikma	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	213261-002	Jul 9, 2021	AP	RX	No	No
Apotex	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	208366-001	Nov 5, 2020		DISCN	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	5,376,634
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	6,265,536
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	6,107,458
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	6,107,458

International Patents for micafungin sodium

Country	Patent Number	Title	Estimated Expiration
Hungary	E066069
Australia	2017376960	Micafungin compositions
World Intellectual Property Organization (WIPO)	2018112330
Japan	2020510619	ミカファンギン組成物

Supplementary Protection Certificates for micafungin sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0788511	08C0028	France		PRODUCT NAME: MICAFUNGINE; REGISTRATION NO/DATE: EU/1/08/448/001-002 20080425
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

Market Dynamics and Financial Trajectory of Micafungin Sodium

Last updated: February 19, 2026

Micafungin sodium is an echinocandin antifungal agent indicated for the treatment of invasive fungal infections. Its market performance is shaped by the prevalence of these infections, competitive landscapes, and patent expiry.

What are the primary indications for micafungin sodium?

Micafungin sodium is primarily indicated for the treatment of candidemia, esophageal candidiasis, and prophylaxis of Candida colonization in hematopoietic stem cell transplant (HSCT) recipients. The drug's efficacy against a broad spectrum of Candida species, including those with reduced susceptibility to azoles, underpins its clinical utility.

Approved Indications and Target Patient Populations:

• Candidemia: Treatment of serious Candida infections in adults and pediatric patients, including those with neutropenia.
• Esophageal Candidiasis: Treatment of esophageal candidiasis in adults and pediatric patients 16 years of age and older.
• Prophylaxis in HSCT: Prevention of Candida colonization and invasive Candida infections in patients undergoing HSCT.

These indications target a significant patient cohort, particularly immunocompromised individuals who are at higher risk for invasive fungal infections. The Centers for Disease Control and Prevention (CDC) reports that invasive fungal infections are a significant cause of morbidity and mortality in these populations.

Who are the key manufacturers and market competitors for micafungin sodium?

The market for micafungin sodium has historically been dominated by Astellas Pharma Inc., the originator, with its branded product, Mycamine. However, the landscape has evolved with the advent of generic competition following patent expirations.

Key Players and Market Dynamics:

• Astellas Pharma Inc. (Originator): Holds the original patents for micafungin sodium.
• Generic Manufacturers: A growing number of companies have entered the market with generic versions of micafungin sodium. These include, but are not limited to:
  • Teva Pharmaceutical Industries Ltd.
  • Hikma Pharmaceuticals PLC
  • Mylan N.V. (now part of Viatris)
  • Fresenius Kabi
  • Sagent Pharmaceuticals, Inc.

The entry of generics has led to price erosion and increased market accessibility. Competition is driven by pricing, supply chain reliability, and the ability to secure formulary placement in hospitals and healthcare systems.

What is the patent landscape for micafungin sodium?

The patent landscape for micafungin sodium is critical for understanding market exclusivity and the timeline for generic entry. The primary patents have expired in major markets, opening the door for generic manufacturers.

Key Patent Expirations and Geographic Markets:

Patent Type	Geographic Region	Expiration Date (Approximate)	Status
Composition of Matter	United States	2017	Expired
Formulation/Use	United States	Various, post-2017	Expired/Pending
Composition of Matter	Europe	2016	Expired
Formulation/Use	Europe	Various, post-2016	Expired/Pending
Composition of Matter	Japan	2015	Expired

Source: Patent databases and company disclosures.

The expiration of the core composition of matter patents allowed for the introduction of generic products. However, secondary patents related to specific formulations, delivery methods, or new indications could potentially extend market exclusivity for the originator or create niche markets. Patent litigation is common in this space, with originators seeking to defend their market position through challenges to generic applications.

What is the global market size and growth trajectory for micafungin sodium?

The global market for micafungin sodium is influenced by the incidence of invasive fungal infections, the availability and cost of alternative treatments, and the penetration of generic products. While specific figures are proprietary, industry analyses indicate a mature market segment with moderate growth.

Market Size and Growth Drivers:

• Prevalence of Invasive Fungal Infections: Rising rates of immunocompromised patients (e.g., cancer, transplant patients, HIV/AIDS) are a primary driver for antifungal drug demand.
• Hospital and Healthcare System Adoption: Antifungal agents are standard of care in critical care and oncology settings.
• Generic Competition: While leading to price declines, the availability of generics expands market reach and overall volume.
• Competition from Other Antifungals: Micafungin sodium competes with other echinocandins (e.g., anidulafungin, caspofungin) and other classes of antifungals (e.g., azoles, polyenes).

Market research reports from firms such as Grand View Research and Mordor Intelligence provide estimates of the global antifungal drug market, of which micafungin sodium is a component. These reports typically project a compound annual growth rate (CAGR) in the low to mid-single digits for the broader antifungal market.

What is the financial performance and profitability of micafungin sodium for key stakeholders?

The financial performance of micafungin sodium varies significantly between the originator and generic manufacturers. Astellas Pharma reported substantial sales of Mycamine during its period of market exclusivity. For generic manufacturers, profitability is primarily driven by volume and cost-effective production.

Financial Considerations:

• Originator (Astellas Pharma): Mycamine generated significant revenue for Astellas Pharma. For example, in fiscal year 2020, Mycamine sales were approximately ¥39.6 billion (USD 380 million at an exchange rate of 100 JPY/USD). [1] As patent protection wanes, originator sales typically decline due to generic competition.
• Generic Manufacturers: Profitability for generic companies is characterized by lower per-unit prices but potentially higher sales volumes. Success hinges on efficient manufacturing, robust distribution networks, and competitive bidding for hospital contracts. Gross margins on generic pharmaceuticals are generally lower than for branded drugs.

The financial trajectory post-patent expiry is one of declining revenue for the originator and a shift in market share towards generic producers. The overall market value may stabilize or grow at a slower pace due to price pressures.

What are the regulatory considerations and challenges impacting micafungin sodium?

Regulatory bodies worldwide oversee the approval, manufacturing, and marketing of micafungin sodium. Compliance with Good Manufacturing Practices (GMP) and post-market surveillance are critical.

Key Regulatory Aspects:

• FDA Approval: The U.S. Food and Drug Administration (FDA) approved Mycamine (micafungin sodium for injection) in 2005. [2] Generic versions also require FDA approval through the Abbreviated New Drug Application (ANDA) process.
• EMA Approval: The European Medicines Agency (EMA) also approved micafungin sodium.
• Pharmacovigilance: Continuous monitoring for adverse events and safety signals is required.
• Manufacturing Standards: Strict adherence to GMP is mandatory for all manufacturers to ensure product quality, safety, and efficacy.
• Intellectual Property Enforcement: Patent disputes and challenges are common regulatory and legal battlegrounds.

Regulatory hurdles can impact the speed of generic market entry and the ability of manufacturers to maintain market access.

What are the future trends and opportunities in the micafungin sodium market?

The future of micafungin sodium is tied to ongoing trends in infectious disease management and the evolution of antifungal resistance.

Future Outlook:

• Emerging Fungal Resistance: The increasing prevalence of antifungal resistance may necessitate new treatment strategies or combination therapies, potentially impacting the role of existing agents like micafungin sodium.
• Pediatric Formulations and Dosing: Continued research into optimized pediatric dosing and potentially novel delivery methods could expand the drug's utility.
• Geographic Market Expansion: Generic manufacturers may seek to expand their reach into emerging markets where antifungal treatment access is growing.
• Combination Therapies: Research into the synergistic effects of micafungin sodium with other antifungal agents or immunomodulatory drugs could lead to new therapeutic approaches.

The market will likely remain competitive, with generic penetration continuing to be a dominant factor in pricing and accessibility.

Key Takeaways

Micafungin sodium is a well-established antifungal agent with a defined set of indications, primarily for immunocompromised patients. The market has transitioned from originator-led exclusivity to a competitive generic landscape following patent expiries in major regions. While the originator, Astellas Pharma, saw significant revenue from Mycamine, generic manufacturers now drive market volume through price competition. The global market for micafungin sodium is mature, with growth moderated by increased generic availability and the presence of alternative antifungal therapies. Future trends will be shaped by the ongoing challenge of antifungal resistance, potential for new therapeutic combinations, and expansion into new geographic markets by generic producers.

Frequently Asked Questions

1. What is the mechanism of action for micafungin sodium?

Micafungin sodium inhibits the synthesis of $\beta(1\to3)$-D-glucan, a critical component of the fungal cell wall. This inhibition leads to cell lysis and fungal death.

2. How does micafungin sodium compare to other echinocandin antifungals?

Micafungin sodium, caspofungin, and anidulafungin are all echinocandins with similar mechanisms of action. Clinical differences often relate to pharmacokinetics, dosing regimens, and specific approvals for certain infections or patient populations. Studies comparing these agents generally show comparable efficacy in treating various Candida infections.

3. Are there any significant drug-drug interactions with micafungin sodium?

Micafungin sodium has a relatively low potential for drug-drug interactions compared to some other antifungal agents, particularly azoles. However, it can interact with drugs that affect cytochrome P450 enzymes and with sirolimus and nifedipine. Healthcare providers must review patient medication lists for potential interactions.

4. What are the common side effects of micafungin sodium?

Common side effects include nausea, vomiting, diarrhea, rash, pruritus, and infusion-related reactions. Hematological changes such as leukopenia and anemia have also been reported.

5. What is the typical route of administration and dosage for micafungin sodium?

Micafungin sodium is administered intravenously. The dosage and duration of treatment depend on the patient's age, weight, clinical condition, and the specific indication being treated. For adult candidemia, a common dose is 100 mg daily.

Cited Sources

[1] Astellas Pharma Inc. (2021). Financial Results for Fiscal Year Ended March 31, 2021. https://www.astellas.com/en/investors/financial-results/financial-results-FY2020

[2] U.S. Food and Drug Administration. (2005). FDA Approves Mycamine (micafungin sodium for injection) for the Treatment of Invasive Fungal Infections. (Press Release).