MICAFUNGIN SODIUM - Generic Drug Details

What are the generic drug sources for micafungin sodium and what is the scope of freedom to operate?

Micafungin sodium is the generic ingredient in four branded drugs marketed by Apotex, Aspiro, Biocon Pharma, Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Jiangsu Hansoh Pharm, Meitheal, Qilu Pharm Hainan, Xellia Pharms Aps, Yichang Humanwell, Zydus Pharms, Astellas, Ph Health, Teva Pharms Usa Inc, and Baxter Hlthcare Corp, and is included in sixteen 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. Thirteen 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:	16
NDAs:	16
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	5
Patent Applications:	924
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
Teva Pharms Usa Inc	MICAFUNGIN	micafungin sodium	POWDER;INTRAVENOUS	212125-001	Jul 30, 2021		DISCN	Yes	No
Zydus Pharms	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	215241-001	Oct 24, 2022	AP	RX	No	No
Hisun Pharm Hangzhou	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	219712-001	Jan 21, 2026	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	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	5,376,634
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	6,265,536

International Patents for MICAFUNGIN SODIUM

Country	Patent Number	Title	Estimated Expiration
Australia	2017376960	Micafungin compositions
Denmark	3554474
European Patent Office	3554474	COMPOSITIONS DE MICAFUNGINE (MICAFUNGIN COMPOSITIONS)
Spain	2972008

Supplementary Protection Certificates for MICAFUNGIN SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Last updated: June 19, 2026

Micafungin Sodium Market Dynamics and Financial Trajectory (Revenue, Pricing, Competition, and Exclusivity)

Micafungin sodium has sustained branded-led revenue in the US and key ex-US markets since approval of IV micafungin for invasive candidiasis, with volume growth driven by hospital formulary uptake and guideline use. Revenue trajectory is shaped by (1) loss of exclusivity timing, (2) generic and authorized generic entrants in select geographies, and (3) competitive pressure from other echinocandins (anidulafungin, caspofungin) that limit pricing power even when micafungin remains the market share leader in several hospital settings.

What is the micafungin sodium market size and revenue trajectory by year?

No complete, reliable year-by-year global revenue dataset is available in the provided information, and producing a quantified trajectory without verifiable source coverage would be incomplete.

Revenue drivers that determine annual trajectory

• Hospital-focused utilization: Micafungin is used largely in inpatient settings for invasive candidiasis prophylaxis and treatment, with demand tied to hospital admissions, oncology and transplant programs, and ICU case mix.
• Formulary position and contracting: Annual revenue tends to track hospital group purchasing organization (GPO) contracting cycles and tender pricing rather than retail dynamics.
• Therapeutic substitution within echinocandin class: Clinicians often switch between echinocandins based on local availability, cost, and specific safety or dosing preferences.
• Guideline adherence: Continued guideline inclusion supports baseline demand, while updates that alter preferred drug selection affect share.

How do generic and authorized generic entries affect micafungin sodium pricing and gross margin?

Generic entry typically compresses realized net price in hospital supply chains, with margins falling faster for the original branded product if rebates and contracting discounts are not rebalanced.

What market dynamics usually follow generic entry

• Rapid net price decline after exclusivity loss, often uneven across channels and geographies due to contracting and inventory cycles.
• Share stabilization when multiple suppliers exist: once several generics are listed, competition becomes less about share capture and more about contract price renegotiation.
• Brand survival via contracting: the branded manufacturer can retain share if it matches price, improves access, or supplies value-based contracting terms.

Why micafungin is exposed to class competition during price compression

Even if micafungin remains a preferred choice, echinocandins compete for the same hospital budget line. When price drops on micafungin, formularies do not always “lock in” the class-leader because therapeutic interchange is common.

When does micafungin sodium lose exclusivity in the US and what does that imply for financial performance?

A definitive exclusivity timeline depends on the exact branded NDA/and or BLA product, Orange Book listing for micafungin sodium, and the relevant patent and exclusivity expiration dates. The necessary Orange Book identifiers and expiration dates are not provided here.

Financial impact pattern around exclusivity expiration

• Pre-expiry: revenue held by scarcity premiums and payer inertia in hospital contracting.
• At-expiry: revenue step-down driven by increased generic competition.
• Post-expiry: stabilization at lower price with persistent volume if suppliers maintain tender and formulary listings.

What patents protect micafungin sodium, and how strong is the patent estate commercially?

Patent strength and enforceability drive the length and magnitude of branded revenue protection. The patent numbers, claims, and jurisdictions are not included in the provided information, so a full patent-coverage assessment cannot be produced.

Commercially relevant patent categories for injectable antifungals

• Composition-of-matter and salt forms
• Manufacturing and crystallization/control processes
• Method-of-use (indication and dosing regimen claims)
• Formulation and stability (lyophilized cake, reconstitution, excipient systems)
• Polymorph/particle characteristics that can affect generic design-around

How does micafungin sodium compare with anidulafungin and caspofungin on market dynamics?

Without sourced share and pricing data, only structural comparisons are possible.

Class substitution effects (how competitors shift micafungin share)

• Procurement-led switching: hospitals may switch to the lowest net-cost echinocandin in recurring tenders.
• Clinical comfort and institutional protocols: centers often standardize one agent for ease of stewardship, but protocols update when a supplier offers better supply terms.
• Safety and administration considerations: dosing convenience and perceived safety profiles influence local switching patterns, especially in ICU and transplant settings.

Typical outcome for micafungin

Micafungin’s financial trajectory is usually less sensitive to incremental clinical differentiation than to procurement and contracting, because echinocandins are broadly interchangeable for many invasive candidiasis use cases in practice.

What is the Orange Book status of micafungin sodium in the US?

Orange Book status requires the specific listed product, NDA number, and listing data. This information is not provided, so an accurate Orange Book mapping cannot be produced.

What patent litigation or Paragraph IV challenges affect micafungin sodium commercialization?

Paragraph IV risk and litigation outcomes materially change the time-to-generic and therefore the branded revenue curve. The provided information contains no docket-level litigation, settlement terms, or court dates, so this cannot be constructed.

What FDA pathway and regulatory milestones shape micafungin sodium supply and uptake?

Micafungin sodium is an established IV antifungal; regulatory milestones typically affect (1) supply continuity, (2) labeling, and (3) post-marketing commitments.

Milestones that matter for financial trajectory

• Label expansions that broaden eligible patient populations.
• Safety communications that influence prescribing comfort.
• Manufacturing changes that can trigger supply disruptions and temporary demand shifts.
• Generic approvals that can alter pricing rapidly if multiple suppliers enter.

How much revenue is exposed to generics and biosimilars risks for micafungin sodium?

Micafungin is a small-molecule injectable antifungal; biosimilar risk is not applicable. Generic exposure depends on specific Orange Book-listed patents and the factual entry timeline in each major market. No listing or entry facts are provided.

Which companies hold key market share and where is competition strongest for micafungin sodium?

Company-level share requires validated market data. In the absence of sourceable share tables, only qualitative competitive structure can be described: micafungin competes with other echinocandins and with any available generic or authorized generic supply depending on geography. A quantified list of competitors cannot be produced from the provided information.

How do hospital formulary and payer contracting dynamics influence micafungin sodium net price?

Net price drivers

• GPO tender pricing and contract renewals determine realized price, not list price.
• Rebate structures shift with competition intensity.
• Switching friction is driven by pharmacy committee governance and infection control protocols.

Market consequence

Even when micafungin remains clinically used, net revenue can decline if contracting prices reset downward after generic entry.

What manufacturing and IP barriers affect supply of micafungin sodium generics?

Supply constraints affect short-term revenue stability for the brand and can delay price erosion. But the specific manufacturing/IP barriers (process patents, regulatory manufacturing approvals, or inspection outcomes) are not provided.

Barriers that commonly influence echinocandin supply entry

• Sterile manufacturing capacity and inspection history.
• Formulation/process controls tied to IP or regulatory review.
• Analytical method validation that can delay tech transfer and commercialization.

Key takeaways

• Micafungin sodium revenue trajectory is primarily shaped by hospital contracting, generics timing, and class competition from anidulafungin and caspofungin.
• Generic or authorized-generic entry typically compresses net price and margins quickly; the degree depends on tender dynamics and the number of competing suppliers.
• A defensible view of exclusivity, patent strength, and litigation impact requires Orange Book listing and case-specific data that are not included in the provided prompt.
• Without quantified sources, this market-dynamics read must be treated as structural rather than forecasted by year.

FAQs

1. How do echinocandin class tenders typically shift micafungin prescribing versus anidulafungin?
2. What factors determine whether the branded micafungin manufacturer retains formulary share after generic entry?
3. Which micafungin labeling changes most affect hospital uptake and reimbursement?
4. How do sterility assurance and sterile manufacturing capacity constraints affect availability of IV antifungals like micafungin?
5. How should a competitor assess Paragraph IV risk for micafungin sodium without relying on list-price revenue?

References

1. No sources were provided in the prompt to cite.