ERAXIS Drug Patent Profile

When do Eraxis patents expire, and when can generic versions of Eraxis launch?

Eraxis is a drug marketed by Vicuron Holdings and is included in one NDA.

The generic ingredient in ERAXIS is anidulafungin. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the anidulafungin profile page.

Summary for ERAXIS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	11
Patent Applications:	4,174
Drug Prices:	Drug price information for ERAXIS
What excipients (inactive ingredients) are in ERAXIS?	ERAXIS excipients list
DailyMed Link:	ERAXIS at DailyMed

See drug prices for ERAXIS

Recent Clinical Trials for ERAXIS

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

Sponsor	Phase
University of Texas Southwestern Medical Center	Phase 4
National Center for Research Resources (NCRR)	Phase 4
Texas Tech University Health Sciences Center	Phase 4

See all ERAXIS clinical trials

Pharmacology for ERAXIS

Drug Class

Echinocandin Antifungal

US Patents and Regulatory Information for ERAXIS

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	021632-001	Feb 17, 2006		RX	Yes	Yes
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006		RX	Yes	Yes

Expired US Patents for ERAXIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006	6,743,777
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006	5,965,525
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-001	Feb 17, 2006	6,743,777
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-001	Feb 17, 2006	6,960,564
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 ERAXIS

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

International Patents for ERAXIS

See the table below for patents covering ERAXIS around the world.

Country	Patent Number	Title	Estimated Expiration
Yugoslavia	49108
Japan	2002226500	CYCLIC PEPTIDE ANTIFUNGAL AGENT AND METHOD FOR PRODUCING THE SAME
Cyprus	1114631
Hungary	T63637
European Patent Office	1582204	Formulations pharmaceutiques d'échinocandine contenant des tensioactifs formant des micelles (Echinocandin pharmaceutical formulations containing micelle-forming surfactants)
China	1345229

Supplementary Protection Certificates for ERAXIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0561639	C00561639/01	Switzerland		PRODUCT NAME: ANIDULAFUNGIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58325 03.09.2009
0561639	CA 2008 00017	Denmark
0561639	SPC002/2008	Ireland		SPC002/2008: 20081105, EXPIRES: 20180317
0561639	91406	Luxembourg		91406, EXPIRES: 20180318
0561639	08C0009	France		PRODUCT NAME: ANIDULAFUNGINE; REGISTRATION NO/DATE: EU/1/07/416/001 20070920
0561639	SPC/GB08/016	United Kingdom		PRODUCT NAME: ANIDULAFUNGIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/416/001 20070920

Market Dynamics and Financial Trajectory for Eraxis (Anidulafungin)

Introduction to Eraxis

Eraxis, also known as anidulafungin, is an intravenous antifungal drug developed by Vicuron Pharmaceuticals and later acquired by Pfizer. It is primarily used for the treatment of candidemia and other forms of invasive candidiasis, which are serious and potentially life-threatening fungal infections[4].

Market Size and Growth

The global echinocandins market, which includes Eraxis, is projected to grow significantly. As of 2021, the echinocandins market was valued at USD 515.20 million and is expected to reach USD 796.69 million by 2029, growing at a CAGR of 5.6% during the forecast period of 2022-2029[1].

Drivers of Market Growth

Several factors are driving the growth of the echinocandins market, including Eraxis:

Rise in Fungal Infections

The increasing incidence of fungal infections, particularly in hospital settings and among immunocompromised patients, is a major driver. These infections are often severe and require effective antifungal treatments like Eraxis[1].

Healthcare Infrastructure and Expenditure

Rising healthcare expenditure and improvements in healthcare infrastructure are also significant factors. These investments enhance the availability and accessibility of advanced antifungal treatments[1].

Research and Development

The ongoing research and development activities, including clinical trials, are expected to further propel the market growth. New indications and improved formulations can expand the market for echinocandins like Eraxis[1].

Competitive Landscape

Eraxis operates in a competitive landscape within the antifungal market:

Patent and Exclusivity Status

Eraxis's patent expired in 2020, but it remained under an exclusivity clause for the treatment of a new patient population until September 2023. Despite the expiration, there were no immediate generic approvals in the pipeline, which helped maintain its market position[3].

Market Share and Sales Projections

When Eraxis was first approved, analysts predicted it would reach sales of $350 million annually by 2010. While specific recent sales figures for Eraxis are not provided, its position in the market is influenced by its efficacy and the lack of immediate generic competition[4].

Financial Impact of Patent Expiration

The expiration of patents and exclusivity clauses can significantly impact a drug's financial performance:

Generic Competition

Although Eraxis did not face immediate generic competition after its patent expiration, the eventual entry of generics can lead to a decline in sales. However, Pfizer's diverse portfolio is expected to mitigate this impact, as seen with other drugs facing similar challenges[3].

Revenue Impact

For smaller companies, the loss of exclusivity can be more critical. However, for Pfizer, the impact is likely to be minimal due to its broad range of products. This is exemplified by the minimal expected impact on Pfizer's bottom line despite the loss of exclusivity for Eraxis[3].

Regional Market Dynamics

The growth of the echinocandins market, including Eraxis, varies by region:

Asia-Pacific

This region is expected to see significant growth due to rising healthcare expenditure and government initiatives to improve healthcare infrastructure. The growing geriatric population and increasing disposable income also contribute to the market's expansion in this region[1].

Challenges and Restraints

Despite the growth potential, there are several challenges facing the echinocandins market:

High Development and Distribution Costs

The high costs associated with drug development and distribution can hinder market growth. Additionally, the increasing number of people with antifungal drug resistance and the lack of healthcare infrastructure in developing economies pose significant challenges[1].

Side Effects

Eraxis, like other echinocandins, can have side effects such as severe rash, itching, fever, and hepatitis, which can act as a market restraint and further impede growth[1].

Key Takeaways

• The echinocandins market, including Eraxis, is expected to grow at a CAGR of 5.6% from 2022 to 2029.
• Rising incidences of fungal infections and improvements in healthcare infrastructure are key drivers.
• The lack of immediate generic competition has helped maintain Eraxis's market position despite patent expiration.
• Regional growth, particularly in the Asia-Pacific region, is driven by increasing healthcare expenditure and government initiatives.
• High development costs, antifungal resistance, and side effects are significant challenges.

FAQs

1. What is Eraxis used for? Eraxis (anidulafungin) is used for the treatment of candidemia and other forms of invasive candidiasis.

2. When did Eraxis lose its patent? Eraxis's patent expired in 2020, but it remained under an exclusivity clause until September 2023.

3. How does the lack of generic competition affect Eraxis's sales? The lack of immediate generic competition has helped maintain Eraxis's sales, as there were no generic approvals in the pipeline after its patent expiration.

4. What are the major drivers of the echinocandins market growth? The major drivers include the rise in fungal infections, increasing healthcare expenditure, and ongoing research and development activities.

5. What are the significant challenges facing the echinocandins market? High development and distribution costs, increasing antifungal drug resistance, lack of healthcare infrastructure in developing economies, and side effects are significant challenges.

Cited Sources

1. Global Echinocandins Market – Industry Trends and Forecast to 2029 - Data Bridge Market Research
2. AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results - AbbVie Investors
3. The Biopharma Patent Cliff: 9 Drugs Losing Exclusivity by the End of 2023 - BioSpace
4. Pfizer blood-infection drug Eraxis approved by FDA - MM+M
5. AbbVie Reports Second-Quarter 2024 Financial Results - AbbVie Investors