Rezafungin acetate - Generic Drug Details

What are the generic sources for rezafungin acetate and what is the scope of freedom to operate?

Rezafungin acetate is the generic ingredient in one branded drug marketed by Mundipharma and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rezafungin acetate has one hundred and one patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for rezafungin acetate

International Patents:	101
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	2
DailyMed Link:	rezafungin acetate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for rezafungin acetate

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for rezafungin acetate

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

Sponsor	Phase
Mundipharma Research Limited	PHASE2
Mundipharma Research Limited	Phase 1

See all rezafungin acetate clinical trials

Pharmacology for rezafungin acetate

Drug Class

Echinocandin Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for rezafungin acetate

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 rezafungin acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mundipharma	REZZAYO	rezafungin acetate	POWDER;INTRAVENOUS	217417-001	Mar 22, 2023		RX	Yes	Yes	11,712,459		Y
Mundipharma	REZZAYO	rezafungin acetate	POWDER;INTRAVENOUS	217417-001	Mar 22, 2023		RX	Yes	Yes	9,526,835		Y	Y
Mundipharma	REZZAYO	rezafungin acetate	POWDER;INTRAVENOUS	217417-001	Mar 22, 2023		RX	Yes	Yes
Mundipharma	REZZAYO	rezafungin acetate	POWDER;INTRAVENOUS	217417-001	Mar 22, 2023		RX	Yes	Yes	8,722,619		Y	Y
Mundipharma	REZZAYO	rezafungin acetate	POWDER;INTRAVENOUS	217417-001	Mar 22, 2023		RX	Yes	Yes	10,702,573		Y	Y
Mundipharma	REZZAYO	rezafungin acetate	POWDER;INTRAVENOUS	217417-001	Mar 22, 2023		RX	Yes	Yes	11,197,909		Y	Y
Mundipharma	REZZAYO	rezafungin acetate	POWDER;INTRAVENOUS	217417-001	Mar 22, 2023		RX	Yes	Yes

International Patents for rezafungin acetate

Country	Patent Number	Title	Estimated Expiration
Portugal	2827710
Hong Kong	1206935	用於棘白菌素類化合物的給藥方案 (DOSING REGIMENS FOR ECHINOCANDIN CLASS COMPOUNDS)
Australia	2019201072
Japan	2018188471	エキノキャンディン系化合物のための投与レジメン (DOSING REGIMENS FOR ECHINOCANDIN CLASS COMPOUNDS)
Japan	2023139211	真菌感染の処置のための投薬レジメン (DOSING REGIMENS FOR TREATMENT OF FUNGAL INFECTIONS)
Spain	2957620
Lithuania	3677252

Supplementary Protection Certificates for rezafungin acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2680873	122024000037	Germany		PRODUCT NAME: REZAFUNGIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE REZAFUNGINACETAT; REGISTRATION NO/DATE: EU/1/23/1775 20231222
2680873	CA 2024 00025	Denmark		PRODUCT NAME: REZAFUNGIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER REZAFUNGINACETAT; REG. NO/DATE: EU/1/23/1775 20231222
2680873	2490021-9	Sweden		PRODUCT NAME: REZAFUNGIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR REZAFUNGIN ACETATE; REG. NO/DATE: EU/1/23/1775 20231222
2680873	PA2024520	Lithuania		PRODUCT NAME: REZAFUNGINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC REZAFUNGINO ACETATAS; REGISTRATION NO/DATE: EU/1/23/1775 20231222
2680873	301280	Netherlands		PRODUCT NAME: REZAFUNGIN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER REZAFUNGINACETAAT; REGISTRATION NO/DATE: EU/1/23/1775 20231222
2680873	LUC00351	Luxembourg		PRODUCT NAME: REZAFUNGIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR REZAFUNGIN ACETATE; AUTHORISATION NUMBER AND DATE: EU/1/23/1775 20231222
2680873	C20240022	Finland

Market Dynamics and Financial Trajectory for Rezafungin Acetate

Last updated: July 28, 2025

Introduction

Rezafungin acetate emerges as a novel antifungal agent targeting invasive fungal infections, notably candidiasis and aspergillosis. Developed by pharmaceutical firms like Cidara Therapeutics, rezafungin's innovative pharmacokinetic profile positions it as a promising alternative to existing therapies. Understanding the market dynamics and financial trajectory involves analyzing clinical development status, competitive landscape, regulatory pathways, commercialization potential, and economic forecasts. This overview provides a comprehensive assessment to guide industry stakeholders, investors, and healthcare providers.

Pharmacological Profile and Clinical Development

Rezafungin is a once-weekly echinocandin designed to address limitations of current antifungal treatments, such as frequent dosing and concerns over resistance. Its stability and long half-life facilitate outpatient therapy, improved patient compliance, and potential reductions in hospitalization costs [1].

Clinical development has progressed through Phase 1 and 2 trials, with Phase 3 pivotal studies evaluating its safety, efficacy, and dosing regimens. Initial results demonstrate comparable or superior outcomes relative to established agents like caspofungin and micafungin, with favorable pharmacodynamic and safety profiles [2].

Market Size and Demand Drivers

The global antifungal market is projected to reach USD 21 billion by 2027, driven by increasing immunocompromised populations, rising transplantation procedures, and an aging demographic vulnerable to fungal infections [3].

Key demand drivers for rezafungin include:

• Growing Incidence of Invasive Fungal Infections: Rising cases of candidemia and invasive aspergillosis in immunosuppressed patients.
• Limitations of Current Therapies: Need for less frequent dosing, reduced toxicity, and improved resistance profiles.
• Hospital-Acquired Infections: The focus on outpatient care reduces hospital stay durations, favoring agents with long dosing intervals.
• Antimicrobial Stewardship: Demand for targeted, efficacious, and safe antifungals aligning with stewardship programs.

Competitive Landscape

Rezafungin faces competition from traditional echinocandins (caspofungin, micafungin, anidulafungin), triazoles, and emerging antifungal candidates. Its unique pharmacokinetics offers a competitive advantage, especially for prophylactic uses, where once-weekly dosing provides operational benefits.

Furthermore, key competitors are investing in next-generation antifungals and combination therapies. While rezafungin's clinical efficacy positioning is promising, market penetration depends on its approval status, pricing, and adoption by healthcare providers.

Regulatory and Commercialization Outlook

Rezafungin's regulatory journey is pivotal. The FDA granted Fast Track designation, expediting review processes. Pending robust Phase 3 data, regulatory approval timelines are likely within 12-18 months, contingent on meeting primary endpoints.

Post-approval, commercialization strategies involve partnerships with healthcare institutions, direct sales, and inclusion in antifungal treatment guidelines. Pricing strategies must balance recouping R&D investments and competitiveness to ensure uptake.

Financial Trajectory and Revenue Projections

The financial outlook for rezafungin depends on several factors:

• Market Penetration Rates: Conservative estimates suggest initial annual sales could reach USD 500 million by year 3 post-launch, assuming approval and successful commercialization.
• Pricing Assumptions: Pricing per treatment course projected at USD 3,000-5,000 aligns with existing echinocandins, ensuring reimbursement feasibility.
• Cost Structures: Manufacturing costs are expected to stabilize below USD 1,000 per course due to scalable synthesis processes.

Scenario analyses reveal that if rezafungin captures 10-20% of the relevant antimicrobial prophylaxis and treatment markets within five years, cumulative revenues could surpass USD 2 billion globally. Operational costs, such as marketing and distribution, will influence EBITDA margins, but profitability is achievable with optimized scale.

Market Adoption and Adoption Barriers

Adoption hinges on:

• Clinical Efficacy and Safety Real-World Data: Positive real-world outcomes bolster clinician confidence.
• Guideline Inclusion: Incorporation into clinical practice guidelines accelerates uptake.
• Pricing & Reimbursement: Favorable payer positions facilitate access.
• Resistance Concerns: Demonstrated activity against resistant strains enhances value proposition.

Barriers include regulatory delays, hesitancy due to new mechanisms, and initial market penetration challenges in regions with established antifungal protocols.

Strategic Opportunities

Potential growth avenues encompass:

• Prophylactic Application in High-Risk Patients: Such as hematopoietic stem cell transplant recipients.
• Hospital Market Expansion: Outpatient infusion services capitalize on weekly dosing.
• Orphan & Niche Markets: Targeting rare fungal infections with limited existing therapies.

Partnerships with biotech firms and expanding clinical trial data can further bolster its market position.

Regulatory and Economic Risks

Risks involve:

• Clinical Trial Failures: Negative data could delay or prevent approval.
• Pricing Pressures: Payer resistance to high-cost new agents.
• Competitive Actions: Launch of advanced antifungal agents or generics could compress market share and margins.
• Manufacturing and Supply Chain Reliability: Ensuring consistent product quality post-approval.

Key Takeaways

• Rezafungin's pharmacokinetic advantages position it favorably in the evolving antifungal market, especially for outpatient and prophylactic use.
• Achieving regulatory approval and clinical acceptance will be critical; early positive trial results are promising.
• The global antifungal market's growth supports significant revenue potential, contingent on successful market entry strategies.
• Pricing and reimbursement models will influence financial outcomes, with premium pricing justified by improved dosing convenience and safety profiles.
• Strategic collaborations, real-world evidence, and guideline endorsements are vital for scaling adoption.

Conclusion

Rezafungin acetate manifests as a compelling candidate poised to disrupt the antifungal therapeutics landscape. Its long-acting profile, positive clinical data, and addressing unmet needs in fungal infection management underpin its potential for robust market penetration and substantial revenue generation. Proactive regulatory engagement, strategic commercialization, and ongoing clinical trials will determine its ultimate financial trajectory.

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FAQs

1. When is rezafungin expected to receive regulatory approval?
Pending completion of Phase 3 trials demonstrating safety and efficacy, regulatory agencies like the FDA are poised to review applications within 12-18 months, with potential approvals anticipated in late 2023 or early 2024.

2. How does rezafungin compare to existing echinocandins?
Rezafungin offers similar antifungal activity with the advantage of once-weekly dosing, potentially improving compliance, outpatient use, and reducing hospital stays compared to current daily-administered echinocandins.

3. What are the main market barriers for rezafungin?
Barriers include regulatory delays, clinician familiarity with current therapies, reimbursement challenges, and competition from emerging antifungal agents or biosimilars that could pressure pricing.

4. What is the projected revenue for rezafungin in the next five years?
If successful, revenues could reach USD 2 billion globally within five years post-launch, assuming moderate market share, favorable reimbursement, and continued clinical validation.

5. Are there any significant resistance concerns associated with rezafungin?
Rezafungin's unique structure and prolonged activity may reduce resistance development, but ongoing surveillance and post-marketing studies are necessary to confirm resistance profiles.

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Sources:

[1] Cidara Therapeutics. Rezafungin (CD201): Pharmacology and Clinical Data.

[2] ClinicalTrials.gov. Rezafungin Phase 2 and Phase 3 Trials.

[3] Grand View Research. Antifungal Market Size, Share & Trends Analysis Report.