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:	53
Clinical Trials:	11
Patent Applications:	4,555
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
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-001	Feb 17, 2006

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/000788Treatment 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
Brazil	9301232
Hungary	211562

Supplementary Protection Certificates for ERAXIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0561639	CA 2008 00017	Denmark
0561639	300334	Netherlands		300334, 20130318, EXPIRES: 20180317

Market Dynamics and Financial Trajectory for ERAXIS (Eravacycline)

Last updated: July 27, 2025

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Introduction

ERAXIS (eravacycline) is an innovative synthetic tetracycline antibiotic developed by Tetraphase Pharmaceuticals. Approved in 2018 by the U.S. Food and Drug Administration (FDA), ERAXIS represents an important advance in combating multi-drug resistant (MDR) bacterial infections. Its unique mechanism and efficacy profile position it within a competitive landscape characterized by increasing antibiotic resistance and a persistent global demand for novel therapeutics. This article offers a comprehensive analysis of the market dynamics influencing ERAXIS and projects its financial trajectory considering current industry trends, competitive forces, and regulatory factors.

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Market Landscape and Disease Burden

The rising prevalence of bacterial infections resistant to existing antibiotics drives the demand for new antimicrobials. According to the CDC, hospitals in the U.S. face an endemic rise in Carbapenem-resistant Enterobacteriaceae (CRE), Pseudomonas aeruginosa, and Acinetobacter baumannii infections—pathogens for which ERAXIS demonstrates activity[1].

Globally, antimicrobial resistance (AMR) is classified by WHO as a significant health threat, exacerbating mortality, morbidity, and healthcare costs. The global antibiotic market is projected to surpass $50 billion by 2027, with higher-margin drugs serving critical niches such as hospital-acquired pneumonia, complicated urinary tract infections, and intra-abdominal infections[2].

ERAXIS’s primary indications—complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI)—align with high-demand treatment areas. Its spectrum of activity against resistant Gram-negative pathogens positions it favorably amid this landscape, especially as existing therapies face limitations due to resistance patterns.

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Competitive Landscape

ERAXIS faces competition primarily from other broad-spectrum antibiotics and novel agents targeting resistant pathogens. Notable competitors include:

• Ertapenem, Meropenem, and other Carbapenems: Standard treatments with broad activity but limited efficacy against carbapenem-resistant strains.

• Tigecycline: Similar spectrum, but with limitations in bloodstream infections and safety concerns.

• Retapamulin and omadacycline: Other tetracycline derivatives with niche applications.

• Newly approved agents such as Imipenem-relebactam and Cefiderocol offer enhanced activity against resistant Gram-negative bacteria and could encroach upon ERAXIS’s market share.

The uniqueness of ERAXIS stems from its demonstrated efficacy against carbapenem-resistant strains and its inventive tetracycline scaffold, which grants it activity against resistant bacteria. Still, the eventual introduction of competing agents with broader indications, better safety profiles, or improved convenience could influence ERAXIS’s market penetration.

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Regulatory and Commercial Considerations

While ERAXIS’s initial FDA approval marked a critical milestone, ongoing regulatory challenges influence its commercial outlook. The drug's orphan designation for specific indications offers market exclusivity, but broader approvals are necessary to expand its utility.

Reimbursement policies and formulary inclusion patterns significantly decide market access. Hospitals and healthcare systems increasingly prioritize antibiotic stewardship, which restricts the use of broad-spectrum agents like ERAXIS to cases with proven necessity, impacting sales volumes.

Moreover, antimicrobial stewardship efforts aim to curb the overuse of antibiotics, potentially limiting ERAXIS’s prescribing frequency despite its clinical benefits. However, the urgent need for effective agents against resistant infections ensures continued demand in high-acuity settings.

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Market Penetration and Adoption Trends

The adoption trajectory of ERAXIS depends on factors including physician awareness, clinical guidelines, and comparative effectiveness data. Despite initial FDA approval, uptake has been modest, attributable to:

• Limited awareness among prescribers.

• The presence of established therapeutic alternatives.

• Pricing strategies and insurance reimbursement considerations.

Nevertheless, as clinical data accumulates demonstrating ERAXIS’s efficacy against resistant pathogens, and as antimicrobial resistance intensifies, physicians are more likely to incorporate ERAXIS into treatment protocols, especially for infections unresponsive to existing options.

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Financial Trajectory Projections

Short-term Outlook (Next 1-3 Years)

In the immediate future, sales of ERAXIS are expected to grow modestly, driven by:

• Increased utilization in hospitals managing resistant infections.

• Expansion of approved indications.

• New clinical trial data supporting broader use.

Tetraphase Pharmaceuticals projected revenues of approximately $20-25 million in 2022, largely from U.S. markets[3]. The company has been investing in clinical research to validate additional indications, which could catalyze growth.

Medium to Long-term Outlook (4-10 Years)

The long-term financial trajectory hinges upon:

• Market Expansion: Approval for broader indications, including community-acquired infections, could significantly elevate sales.

• Global Markets: Expanding into Europe, Asia, and other regions offering higher growth potential.

• Competitive Dynamics: Entry of newer agents could erode ERAXIS’s market share unless it maintains clinical advantages.

• Pricing and Reimbursement: Reimbursement policies remain critical, especially as antibiotic stewardship evolves.

Given these factors, a reported compound annual growth rate (CAGR) of 8-12% for ERAXIS’s sales over the next five years appears plausible, assuming additional indications, broader market access, and stable competitive positioning[4].

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Challenges and Opportunities

Challenges

• Resistance Development: The emergence of resistance to ERAXIS can curtail its long-term utility.

• Market Saturation: Competition from other new agents could limit growth.

• Pricing Pressures: Healthcare payers’ push for cost containment could restrain profitable pricing strategies.

Opportunities

• Combination Therapy: Combining ERAXIS with other antibiotics could expand its efficacy.

• Specialized Niches: Targeting multi-drug resistant pathogens in niche hospital settings.

• Strategic Partnerships: Collaborations with global pharma entities can accelerate approvals and market access.

• Clinical Pipeline Expansion: Ongoing trials in severe infections like ventilator-associated pneumonia (VAP) could unlock further revenue avenues.

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Regulatory and Policy Impact

Regulatory authorities’ increasing emphasis on antimicrobial resistance metrics incentivizes approval and adoption of novel antibiotics like ERAXIS. The FDA’s Qualified Infectious Disease Product (QIDP) designation for eravacycline offers incentives such as priority review and extended market exclusivity. Such policies support the drug’s long-term commercial viability, especially if approved for additional indications.

However, regulators also emphasize stewardship, demanding robust post-market surveillance data that may influence prescribing behavior and coverage decisions.

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Key Takeaways

• ERAXIS caters to a high-need market segment driven by rising antibiotic resistance and limited current treatment options.

• Market penetration remains limited but has potential to grow with broader indications, increased clinical familiarity, and geographic expansion.

• Competition from other advanced antibiotics and evolving resistance patterns represent both a challenge and an incentive for ongoing innovation.

• The financial trajectory indicates modest early growth with prospects for accelerated sales contingent upon regulatory approvals, clinical validation, and strategic collaborations.

• Payers’ reimbursement policies and stewardship initiatives pose challenges but also offer opportunities to demonstrate ERAXIS’s value in targeted, resistant infections.

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FAQs

1. What are the primary hurdles in expanding ERAXIS’s market share?
Limited awareness among clinicians, competition from newer antibiotics, resistance development, and reimbursement constraints hinder market expansion.

2. How does ERAXIS’s mechanism of action differentiate it from other antibiotics?
ERAXIS is a synthetic tetracycline that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, with enhanced activity against resistant strains due to structural modifications.

3. Can ERAXIS be used to treat outpatient infections?
Currently, ERAXIS is primarily approved for hospital-associated infections. Its use in outpatient settings depends on future approvals and clinical guidelines.

4. What role do regulatory incentives play in ERAXIS’s commercial outlook?
Designations like QIDP provide market exclusivity and expedited review, encouraging investment and facilitating market entry.

5. How might global markets influence ERAXIS’s long-term revenue?
Approval and adoption in Europe and Asia can substantially augment revenues, especially in regions with high resistance burdens and unmet medical needs.

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References

[1] CDC. Antibiotic Resistance Threats in the United States, 2019.

[2] Grand View Research. Antibiotic Market Size & Trends Report, 2020-2027.

[3] Tetraphase Pharmaceuticals. Annual Report, 2022.

[4] EvaluatePharma. 2023 World Preview - Outlook to 2028.

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