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:	37
Patent Applications:	4,963
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
Scynexis, Inc.	Phase 3
ZonMw: The Netherlands Organisation for Health Research and Development	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

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/000788 Treatment 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 Experimental

Market Dynamics and Financial Trajectory of Anidulafungin

Market Overview

Anidulafungin, a semi-synthetic echinocandin antifungal drug, is gaining significant traction in the global pharmaceutical market due to its efficacy in treating various fungal infections, including candidemia and other forms of invasive candidiasis.

Market Size and Growth

The global anidulafungin market was valued at US$ 156 million in 2023 and is projected to reach US$ 195.6 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 3.3% during the forecast period of 2024-2030[1][3].

Segmentation

By Type

The market is segmented based on the dosage forms of anidulafungin, primarily 50 mg per vial and 100 mg per vial. These segments are crucial as they cater to different treatment needs and patient populations[1][3][4].

By Application

Anidulafungin is predominantly used in hospitals and drugstores. The hospital segment is a major driver due to the high incidence of fungal infections in immunocompromised patients and those in intensive care units (ICUs)[1][3].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth dynamics driven by factors such as healthcare infrastructure, disease prevalence, and regulatory environments[1][3][4].

Key Players

The anidulafungin market is dominated by key players such as Pfizer and BrightGene Bio-Medical Technology. These companies play a significant role in manufacturing, distribution, and marketing of the drug[1][3].

Cost-Effectiveness and Budgetary Impact

Anidulafungin has been shown to be cost-effective compared to other antifungal treatments like amphotericin B deoxycholate (ABD) and amphotericin B lipid complex (ABLC). A study conducted in the Brazilian Unified Health System (SUS) indicated that the use of anidulafungin could result in savings of approximately 148 million reais over five years when compared to ABD. This is due to its better cost-effectiveness ratio and lower incidence of nephrotoxicity, which reduces the need for dialysis and other costly interventions[2].

Clinical Indications and Mechanism of Action

Anidulafungin is indicated for the treatment of candidemia, intra-abdominal abscesses, peritonitis, esophageal candidiasis, and other forms of invasive candidiasis. It works by inhibiting glucan synthase, an enzyme essential for the formation of the fungal cell wall, leading to osmotic instability and cell death[5].

Market Drivers

Increasing Incidence of Fungal Infections

The rise in immunocompromised patient populations, particularly those with HIV/AIDS, cancer, and organ transplant recipients, has led to an increased incidence of fungal infections. This trend is expected to drive the demand for effective antifungal treatments like anidulafungin[1][3].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in developing regions, are enhancing the accessibility and affordability of antifungal treatments. This expansion is likely to boost the market growth of anidulafungin[1][3].

Regulatory Approvals and Recommendations

International scientific societies recommend anidulafungin as a first-line treatment for invasive candidiasis, which has been a significant factor in its market adoption. Regulatory approvals and positive clinical trial outcomes further support its market trajectory[2][5].

Market Restraints

Competition from Alternative Treatments

The antifungal market is competitive, with several other treatments available, including amphotericin B formulations and other echinocandins. This competition can limit the market share of anidulafungin[1][2].

High Development and Production Costs

The development and production of anidulafungin are costly, which can impact its pricing and accessibility in some markets. This could be a restraint, especially in regions with limited healthcare budgets[1][3].

Financial Trajectory

Revenue Forecast

The anidulafungin market is expected to grow steadily, with revenues increasing from US$ 156 million in 2023 to US$ 195.6 million by 2030. This growth is driven by increasing demand, expanding healthcare infrastructure, and the drug's cost-effectiveness[1][3].

Cost-Benefit Analysis

Studies have shown that anidulafungin offers significant cost savings when compared to other antifungal treatments. For instance, the budget impact analysis in the Brazilian health system indicated potential savings of up to R$ 148 million over five years[2].

Regional Analysis

North America and Europe

These regions are expected to dominate the market due to advanced healthcare systems, high disease prevalence, and strong regulatory frameworks that support the use of anidulafungin[1][3].

Asia-Pacific

This region is anticipated to show significant growth due to increasing healthcare spending, improving infrastructure, and a large patient population. Countries like China and India are expected to be key markets[1][3].

Key Takeaways

• Market Growth: The anidulafungin market is projected to grow at a CAGR of 3.3% from 2024 to 2030.
• Cost-Effectiveness: Anidulafungin is cost-effective compared to other antifungal treatments, leading to potential savings in healthcare costs.
• Clinical Indications: It is used for treating various fungal infections, including candidemia and esophageal candidiasis.
• Market Drivers: Increasing incidence of fungal infections, advancements in healthcare infrastructure, and regulatory approvals are driving the market.
• Market Restraints: Competition from alternative treatments and high development costs are potential restraints.

FAQs

What is the expected market size of anidulafungin by 2030?

The global anidulafungin market is expected to reach US$ 195.6 million by 2030[1].

Which companies are the main players in the anidulafungin market?

The main players in the anidulafungin market include Pfizer and BrightGene Bio-Medical Technology[1].

What are the primary clinical indications for anidulafungin?

Anidulafungin is indicated for the treatment of candidemia, intra-abdominal abscesses, peritonitis, esophageal candidiasis, and other forms of invasive candidiasis[5].

How does anidulafungin compare to other antifungal treatments in terms of cost-effectiveness?

Anidulafungin has been shown to be more cost-effective than treatments like amphotericin B deoxycholate (ABD) and amphotericin B lipid complex (ABLC), with potential savings of up to R$ 148 million over five years[2].

What are the key drivers of the anidulafungin market?

The key drivers include the increasing incidence of fungal infections, advancements in healthcare infrastructure, and regulatory approvals and recommendations[1][2][3].

Sources

1. Global Anidulafungin for Injection Market Research Report 2024 - Valuates Reports
2. Cost-effectiveness analysis and budgetary impact of anidulafungin - SciELO
3. Global anidulafungin market size and forecast - Market Research Intellect
4. Anidulafungin Market Report 2024 (Global Edition) - Cognitive Market Research
5. Anidulafungin: Uses, Interactions, Mechanism of Action - DrugBank