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
ZonMw: The Netherlands Organisation for Health Research and Development	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	5,965,525
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006	7,709,444
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-001	Feb 17, 2006	5,965,525
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006	6,384,013

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

Market Dynamics and Financial Trajectory for Anidulafungin

Last updated: July 28, 2025

Introduction

Anidulafungin, a second-generation echinocandin antifungal agent, has established its position in the management of invasive fungal infections such as candidemia and other serious fungal diseases. Developed by pharmaceutical companies to combat resistant fungal strains, Anidulafungin's unique pharmacological profile and clinical efficacy have influenced its market trajectory significantly. This article explores the evolving market dynamics, competitive landscape, regulatory developments, and financial prospects shaping Anidulafungin's future.

Pharmacological Profile and Clinical Significance

Anidulafungin offers a targeted approach against Candida and Aspergillus species by inhibiting cell wall synthesis. Its once-daily intravenous formulation allows for ease of use in hospitalized settings, particularly intensive care units. Unlike other echinocandins, Anidulafungin displays a favorable safety profile with minimal hepatic metabolism, reducing drug-drug interactions [1]. These pharmacological strengths enhance its clinical adoption, especially for critically ill patients, underpinning its demand in hospitals globally.

Current Market Landscape

Global Market Size and Growth Trends

The global antifungal market was valued at approximately USD 10 billion in 2022, with echinocandins contributing a significant share. Anidulafungin, although competing with Caspofungin and Micafungin—market leaders—has steadily increased its market share, driven by its distinctive clinical profile and expanding indications [2].

The compound's growth is projected at a CAGR of approximately 5.8% over the next five years, influenced by factors including rising invasive fungal infection cases, advancements in critical care, and increasing awareness of antifungal resistance. Hospital expenditure on antifungals and supportive healthcare infrastructure expansion will further propel demand [3].

Regional Dynamics

• North America: Dominates the market due to high adoption rates, extensive healthcare infrastructure, and favorable reimbursement policies. The U.S. accounts for about 45% of the global market share for echinocandins.
• Europe: Shows steady growth, with strong clinical guidelines endorsing antifungal therapies, including Anidulafungin.
• Asia-Pacific: Emerges as a high-growth region owing to increasing healthcare access, rising fungal disease prevalence, and developing pharmaceutical manufacturing capabilities.

Key Drivers

• Rising Incidence of Fungal Infections: Globally, candidemia prevalence is increasing, especially among immunocompromised populations, such as cancer patients, transplant recipients, and ICU cases [4].
• Growing Critical Care Population: Increased hospital admissions, ICU stays, and invasive procedures lead to higher antifungal utilization.
• Advancements in Diagnostics: Improved detection methods facilitate earlier intervention, boosting antifungal treatment needs.
• Regulatory Approvals and Expanded Indications: Ongoing approvals for use in pediatric and prophylactic settings expand market scope.

Competitive Landscape

Major Players and Market Share

Anidulafungin is marketed predominantly by Pfizer, under the trade name Eraxis. It competes primarily with Caspofungin (Merck) and Micafungin (Fujifilm). Pfizer's global distribution network, clinical data, and established reputation bolster Anidulafungin's market position.

Market Challenges

• Pricing and Reimbursement Barriers: Higher costs compared to generic antifungals constrain adoption in resource-limited settings.
• Competition from Emerging Therapies: Novel antifungal agents and resistance to existing treatments challenge market share.
• Limited Oral Formulation: Currently only available intravenously, which limits outpatient use and long-term management alternatives.

Regulatory Approvals and Pipeline

While Anidulafungin has received approvals in major markets, ongoing clinical trials examine its efficacy in prophylactic use, pediatric applications, and resistant strains, potentially expanding its label. The company's pipeline also explores combination therapies to address antifungal resistance.

Financial Trajectory and Investment Outlook

Revenue Trends

Pfizer's antifungal segment reports consistent growth, with Anidulafungin contributing steadily. In 2022, the segment generated approximately USD 2.4 billion globally, with Anidulafungin's revenues estimated to account for 15-20%, driven by global sales in hospital formulary listings [5].

Pricing Strategies and Market Penetration

Premium pricing maintains profitability, yet payers' focus on cost-effective therapies pressures pharmaceutical companies to optimize pricing. Strategic alliances with healthcare providers and inclusion in treatment guidelines support market penetration.

Potential for Market Expansion

• Developing Markets: Increasing healthcare expenditures and rising fungal infections provide untapped opportunities.
• Prophylactic Indications: Expansion into prevention of fungal infections in immunocompromised patients could unlock new revenue streams.
• Formulation Innovations: Development of oral or long-acting formulations may broaden usage beyond hospital settings.

Risks and Uncertainties

• Stringent regulatory environments and patent expirations could impact market exclusivity.
• Emergence of resistance or safety concerns may reduce clinical utility.
• Economic pressures and healthcare policy reforms may influence reimbursement policies.

Regulatory and Patent Landscape

• Patent Status: Pfizer's patents for Anidulafungin are active till 2025-2027 in key jurisdictions, providing market exclusivity and pricing power.
• Regulatory Environment: Stringent approval processes necessitate ongoing pharmacovigilance, but positive clinical outcomes continue to support expansion.
• Generic Competition: Expected post-patent expiry could intensify price competition and reduce revenues.

Future Outlook

The outlook for Anidulafungin remains cautiously optimistic. With continued clinical research, regulatory approvals, and strategic market expansion, sales are likely to sustain steady growth. However, competitive pressures, resistance issues, and cost concerns necessitate adaptive strategies by stakeholders.

Key Takeaways

• Growing Demand: Rising invasive fungal infections globally, particularly in critical care and immunocompromised populations, underpin sustained demand for Anidulafungin.
• Regional Opportunities: Expanding markets in Asia-Pacific and Latin America provide significant growth potential.
• Market Challenges: Price sensitivity, competition, and resistance necessitate innovation and strategic partnerships.
• Pipeline Development: Clinical trials for prophylactic and pediatric uses could diversify revenue streams.
• Regulatory and Patent Considerations: Patent expirations post-2025 may impact future profitability, underscoring the importance of pipeline diversification.

FAQs

1. How does Anidulafungin differ from other echinocandins?
Anidulafungin boasts a favorable safety profile, minimal hepatic metabolism, and once-daily intravenous dosing, offering advantages in safety and outpatient management over competitors.

2. What are key factors influencing Anidulafungin’s market growth?
Increasing fungal infection cases, expansion in indications, hospital adoption, and regional demand in emerging markets drive growth.

3. What are potential barriers to Anidulafungin’s market expansion?
High drug pricing, lack of oral formulation, patent expirations, and emerging antifungal resistance pose challenges.

4. Are there upcoming regulatory approvals for Anidulafungin?
While existing approvals are stable, ongoing clinical trials may lead to new indications, such as prophylactic use in immunocompromised patients.

5. What strategies can stakeholders employ to maximize Anidulafungin’s commercial potential?
Investing in pipeline expansion, exploring new formulations, engaging in strategic partnerships, and optimizing pricing policies can enhance market leverage.

References

1. Pfizer. (2022). Anidulafungin Data Sheet and Clinical Profile.
2. MarketWatch. (2023). Antifungal Market Reports.
3. GlobalData. (2022). Infectious Disease Market Forecast.
4. CDC. (2021). Fungal Infections Statistics.
5. Pfizer Financial Reports. (2022). Antifungal Segment Results.