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, Xellia Pharms Aps, Zydus Pharms, Astellas, Endo Operations, Teva Pharms Usa Inc, and Baxter Hlthcare Corp, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for micafungin sodium

US Patents:	0
Tradenames:	4
Applicants:	12
NDAs:	12
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	5
Patent Applications:	121
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
Zydus Pharms	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	215241-001	Oct 24, 2022	AP	RX	No	No
Xellia Pharms Aps	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	211713-002	Jun 2, 2021	AP	RX	No	No
Biocon Pharma	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	216438-002	May 29, 2024	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	021506-003	Jun 27, 2006
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006

Micafungin sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Micafungin Sodium

Market Size and Growth Projections

The micafungin sodium market is poised for significant growth over the coming years. As of 2023, the market size was valued at USD 3.49 billion and is projected to reach USD 6.38 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 8.2% during the forecast period[1].

Key Drivers of Market Growth

Several factors are driving the growth of the micafungin sodium market:

Increasing Prevalence of Fungal Infections

The rise in invasive fungal infections, particularly among immunocompromised patients, is a major driver. The World Health Organization (WHO) has reported an increase in fungal infections, leading to a heightened demand for effective antifungal treatments like micafungin sodium[3].

Advancements in Pharmaceutical Formulations

Innovations in drug formulations and delivery methods have enhanced the efficacy, stability, and convenience of micafungin sodium administration. This includes the development of injectable formulations, which are preferred in hospital settings[1].

Regulatory Approvals and Market Expansion

New approvals and indications for micafungin sodium can open up additional market opportunities, especially in regions with improving healthcare access. Regulatory environments, such as those in the EU, facilitate drug approval processes, further boosting market growth[1].

Healthcare Infrastructure Development

Improvements in healthcare infrastructure, particularly in developing regions, increase the accessibility of antifungal treatments. This is evident in regions like the Asia-Pacific, where rising healthcare expenditures and growing awareness of fungal infections are driving market growth[1].

Distribution Channels and End-User Segments

Distribution Channels

The micafungin sodium market is segmented by distribution channels, primarily including hospitals, clinics, and online pharmacies. Hospitals are the primary distribution channel due to the urgent and frequent need for this medication, especially for treating fungal infections in hospitalized patients[1].

End-User Segments

The market is categorized into key end-user segments, including healthcare providers (hospitals, clinics, and specialized treatment centers) and pharmaceutical companies. Healthcare providers directly influence adoption rates and treatment protocols, while pharmaceutical companies play a crucial role in manufacturing, distribution, and research and development[1].

Geographical Market Dynamics

North America and Europe

North America, particularly the United States, and Europe are dominant players in the micafungin sodium market. These regions benefit from advanced healthcare systems, high healthcare expenditures, and robust research and development initiatives. The CDC has reported a rising trend in candidiasis cases, underscoring the demand for effective antifungal treatments in these regions[3].

Asia-Pacific and Emerging Markets

The Asia-Pacific region is witnessing rapid growth driven by increasing healthcare access and rising awareness of fungal infections. Countries like India and China are investing heavily in healthcare, leading to a higher demand for antifungal treatments. Latin America is also emerging as a significant market, although access to sophisticated treatments can be limited[1][3].

Financial Trajectory and Recent Transactions

Market Value and Growth Rate

The market is expected to grow significantly, with a projected CAGR of 8.2% from 2024 to 2031. However, some reports suggest varying growth rates, with one indicating a decline to USD 286.8 million by 2030 at a CAGR of -2.4%, though this seems to be an outlier compared to other projections[1][4].

Asset Purchase Agreements

A notable financial transaction involves Astellas Pharma Inc. transferring the worldwide product rights for micafungin sodium (MYCAMINE) to Sandoz AG. The agreement includes an upfront payment of USD 62.5-75 million and potential sales-based milestone payments. This transaction is part of Astellas’ efforts to optimize resource allocation and achieve sustainable growth[2].

Competitive Landscape

The micafungin sodium market is characterized by strategic investments in research and development, diverse pricing models, and proactive market access strategies. Key players include Astellas Pharma Inc., Pfizer Inc., Reddy’s Laboratories Ltd., Mylan N.V., Sun Pharmaceutical Industries Ltd., and Cipla Ltd. These companies are engaged in enhancing formulations, improving efficacy, and determining new indications for micafungin sodium[1].

Future Projections

The demand for micafungin sodium is expected to surge due to rising global incidences of fungal infections and increasing awareness of antifungal treatments. The global antifungal market is projected to reach approximately USD 16 billion by 2025, with micafungin sodium capturing a notable share due to its favorable safety profile and ease of administration. The shift towards outpatient care and personalized medicine further enhances the prospects for this drug[3].

Key Takeaways

• The micafungin sodium market is projected to grow significantly, driven by increasing fungal infections and advancements in pharmaceutical formulations.
• North America and Europe are dominant markets, while the Asia-Pacific region is emerging as a significant growth area.
• Hospitals and healthcare providers are crucial distribution channels and end-users.
• Strategic transactions, such as the asset purchase agreement between Astellas and Sandoz, are shaping the market landscape.
• The market is expected to reach USD 6.38 billion by 2031, growing at a CAGR of 8.2%.

Frequently Asked Questions (FAQs)

Q: What is the projected market size of micafungin sodium by 2031? A: The micafungin sodium market is projected to reach USD 6.38 billion by 2031[1].

Q: Which regions are driving the growth of the micafungin sodium market? A: North America and Europe are currently dominant, while the Asia-Pacific region is emerging as a significant growth area[1][3].

Q: What are the primary distribution channels for micafungin sodium? A: The primary distribution channels include hospitals, clinics, and online pharmacies, with hospitals being the most critical due to urgent needs[1].

Q: Who are the key players in the micafungin sodium market? A: Key players include Astellas Pharma Inc., Pfizer Inc., Reddy’s Laboratories Ltd., Mylan N.V., Sun Pharmaceutical Industries Ltd., and Cipla Ltd.[1].

Q: What is the significance of the asset purchase agreement between Astellas and Sandoz? A: The agreement involves the transfer of worldwide product rights for micafungin sodium, reflecting Astellas’ strategy to optimize resource allocation and achieve sustainable growth[2].

Cited Sources:

1. Verified Market Research - Micafungin Sodium For Injection Market Size And Forecast[1]
2. Astellas - Astellas Transfers MYCAMINE ® Product Worldwide News[2]
3. PMarketResearch - Worldwide Micafungin Sodium Drug Market Research 2024 by Type, Application, Participants, and Countries Forecast to 2030[3]
4. Valuates Reports - Micafungin Sodium for Injection Market Size[4]