ANIDULAFUNGIN - Generic Drug Details

What are the generic sources for anidulafungin and what is the scope of patent protection?

Anidulafungin is the generic ingredient in one branded drug marketed by Vicuron Holdings and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for anidulafungin. One supplier is listed for this compound.

Summary for ANIDULAFUNGIN

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	38
What excipients (inactive ingredients) are in ANIDULAFUNGIN?	ANIDULAFUNGIN excipients list
DailyMed Link:	ANIDULAFUNGIN at DailyMed

Recent Clinical Trials for ANIDULAFUNGIN

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

Sponsor	Phase
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	PHASE4
Scynexis, Inc.	Phase 3
Stichting Hemato-Oncologie voor Volwassenen Nederland	Phase 3

See all ANIDULAFUNGIN clinical trials

Pharmacology for ANIDULAFUNGIN

Drug Class

Echinocandin Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for ANIDULAFUNGIN

J02AX	Other antimycotics for systemic use
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for ANIDULAFUNGIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006		RX	Yes	Yes
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-001	Feb 17, 2006		RX	Yes	Yes

Expired US Patents for ANIDULAFUNGIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-001	Feb 17, 2006
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-001	Feb 17, 2006
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-001	Feb 17, 2006

EU/EMA Drug Approvals for ANIDULAFUNGIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Ecalta	anidulafungin	EMEA/H/C/000788Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years.	Authorised	no	no	no	2007-09-20

ANIDULAFUNGIN Market Analysis and Financial Projection

Last updated: February 14, 2026

What Is the Current Market Size and Growth Trajectory for Anidulafungin?

Anidulafungin, an antifungal agent, has an established role primarily in hospital settings for invasive candidiasis. The global antifungal market was valued at approximately USD 5.3 billion in 2022, with echinocandins, including anidulafungin, representing about 20% of this figure (around USD 1.06 billion) [1]. The market is projected to grow at a compound annual growth rate (CAGR) of roughly 7% from 2023 to 2030, driven mainly by increasing fungal infections and rising antifungal resistance [2].

Within this context, anidulafungin accounts for an estimated 15-20% of echinocandin sales, which translates to USD 160-210 million in 2022. Its market share remains stable, supported by its broad-spectrum activity, minimal drug interactions, and favorable safety profile.

How Do Pricing and Revenue Trends Evolve for Anidulafungin?

Pricing for anidulafungin varies across regions. In the US, hospitals typically pay between USD 50 and USD 70 per 50 mg vial, translating into about USD 2,500 to USD 3,500 per treatment course for an average patient [3]. These figures reflect high ICU utilization rates, as inpatient fungemia treatments rarely extend beyond a week.

Revenue growth for the drug is constrained by generic competition in some markets, although patent protections and exclusivity in major regions have limited this. Several generics entered the European market post-2018, causing price reductions of approximately 20-30% in those regions [4]. In the US, the drug remains under patent protection until at least 2028, with some regional patent extensions possible.

What Are the Key Drivers and Barriers in the Anidulafungin Market?

Drivers:

• Rising incidence of candidemia and invasive fungal infections, particularly among immunocompromised and ICU patients.
• Increasing awareness and diagnostic improvements leading to higher detection rates.
• High efficacy against Candida species, including fluconazole-resistant strains.
• Favorable safety profile and fewer drug interactions compared to alternative antifungals like azoles.

Barriers:

• High treatment costs relative to existing options, limiting use in resource-constrained settings.
• Competition from other echinocandins, such as caspofungin and micafungin, which are marketed globally.
• Limited oral formulations; anidulafungin is only available intravenously, which restricts outpatient use.
• Patent expiry timelines influence pricing and market entry of generics.

What Is the Financial Outlook for Anidulafungin Product Developers?

Currently, the commercial landscape is characterized by limited players — Fresenius Kabi and Pfizer (through its acquisition of a majority stake in the drug from Boehringer Ingelheim) dominate sales in key markets. Pfizer's portfolio includes a marketed formulation under the name Eraxis in the US.

The introduction of generics post-patent expiration is expected to pressure prices downward by 30-50%, reducing revenue per unit. Forecasts suggest that the branded drug's global sales could decline from USD 200 million in 2022 to around USD 100 million by 2030, assuming no new indications or formulations.

However, emerging markets are seeing increased adoption, partly due to lower prices and expanding healthcare infrastructure. These markets could offset some declines experienced in developed nations.

Are There Opportunities for Market Expansion or Product Differentiation?

Developing oral formulations or combination therapies could enable outpatient management, expanding the drug's use beyond inpatient settings. Additionally, exploring new indications, such as prophylactic uses in high-risk transplant or oncology patients, could create new revenue streams.

Combination therapy trials with other antifungals are ongoing, aiming to improve efficacy and resistance management. Regulatory pathways in emerging markets remain less saturated, presenting potential for licensing and registration.

What Strategic Considerations Should Stakeholders Prioritize?

• Patent management to delay generic entry, including regional extensions.
• Investment in formulation innovations to broaden administration routes.
• Focused marketing on clinical evidence demonstrating superiority or safety advantages.
• Market access strategies addressing cost sensitivities, especially in developing regions.

Key Takeaways

• The global anidulafungin market was valued at about USD 160-210 million in 2022 and is projected to grow at a 7% CAGR until 2030.
• Revenue growth faces pressure from generics after patent expiry and competition from other echinocandins.
• Pricing varies widely, influenced by region-specific healthcare policies and market competition.
• Key drivers include increasing fungal infections, resistance mitigation, and safety profiles; barriers involve high costs and limited formulations.
• Opportunities exist in developing oral formulations, expanding indications, and targeting emerging markets.

FAQs

1. When does patent expiration threaten anidulafungin's exclusivity?
   Patent protections extend until at least 2028 in major markets, with regional extensions possible.

2. Are there generic versions of anidulafungin available?
   Generics have entered some regions, notably Europe, post-patent expiry, leading to price reductions.

3. What are the main competitors to anidulafungin?
   Candidiasis treatments like caspofungin and micafungin, also echinocandins, dominate the market.

4. Can anidulafungin be used outside hospital settings?
   Currently, no; the lack of oral formulations limits outpatient application.

5. What clinical developments could impact the market?
   New indications, improved formulations, and combination therapies could expand usage and revenue potential.

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References

[1] MarketResearch.com, 2022. "Global Antifungal Market Overview."
[2] Future Market Insights, 2023. "Antifungal Agents Market Forecast 2023-2030."
[3] Drug Pricing Reports, 2022. "Anidulafungin Price Trends."
[4] European Medicines Agency, 2018. "Post-Patent Market Entry and Price Dynamics."