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REZZAYO Drug Patent Profile

Which patents cover Rezzayo, and when can generic versions of Rezzayo launch?

Rezzayo is a drug marketed by Mundipharma and is included in one NDA. There are seven patents protecting this drug.

This drug has ninety-two patent family members in twenty-four countries.

The generic ingredient in REZZAYO is rezafungin acetate. One supplier is listed for this compound. Additional details are available on the rezafungin acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Rezzayo

Rezzayo will be eligible for patent challenges on March 22, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 22, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for REZZAYO

International Patents:	92
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for REZZAYO
What excipients (inactive ingredients) are in REZZAYO?	REZZAYO excipients list
DailyMed Link:	REZZAYO at DailyMed

See drug prices for REZZAYO

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

217417

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.

Pharmacology for REZZAYO

Drug Class

Echinocandin Antifungal

US Patents and Regulatory Information for REZZAYO

REZZAYO is protected by seven US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	10,702,573		Y	Y
Mundipharma	REZZAYO	rezafungin acetate	POWDER;INTRAVENOUS	217417-001	Mar 22, 2023		RX	Yes	Yes	11,819,533		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 REZZAYO

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

Country	Patent Number	Title	Estimated Expiration
Canada	2867132
Poland	3677252
Canada	2867132	POSOLOGIES POUR COMPOSES DE LA CLASSE DES ECHINOCANDINES (DOSING REGIMENS FOR ECHINOCANDIN CLASS COMPOUNDS)
Spain	2955711

REZZAYO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for REZZAYO

Introduction to REZZAYO

REZZAYO, developed by Cidara Therapeutics, is a novel once-weekly echinocandin antifungal drug approved for the treatment of candidemia and invasive candidiasis in adults. This drug marks a significant advancement in antifungal therapy, being the first FDA-approved echinocandin in over a decade.

Market Approval and Expansion

FDA Approval in the U.S.

In March 2023, REZZAYO received FDA approval for treating candidemia and invasive candidiasis in adults with limited options. This approval was a crucial milestone, highlighting the drug's potential in managing fungal infections as demonstrated in clinical trials[1].

European and UK Approvals

Following the U.S. approval, REZZAYO was approved in the European Union and the United Kingdom in December 2023 and January 2024, respectively. These approvals were triggered by positive results from the ReSTORE Phase III clinical trial, which showed non-inferiority to the standard of care, caspofungin[3][4].

Market Penetration and Adoption

Addressing a Treatment Gap

The introduction of REZZAYO addresses a significant gap in the antifungal market, particularly since it is the first new treatment option in 15 years. This gap is expected to drive increased adoption rates among healthcare providers, given the drug's convenient weekly dosing regimen and non-inferiority to existing treatments[4].

Clinical Significance

REZZAYO's approval is clinically significant as it provides a new treatment option for invasive candidiasis, a serious infection with high morbidity and mortality rates. The drug's weekly dosing regimen offers improved patient compliance and outcomes compared to daily dosing of current treatments[4].

Financial Trajectory

Revenue and Milestone Payments

Cidara Therapeutics has seen significant financial benefits from the approvals and commercialization of REZZAYO. The company received milestone payments of approximately $11.1 million and $2.8 million from Mundipharma for the EU and UK approvals, respectively[3][5].

Revenue Streams

For the year ended December 31, 2023, Cidara's revenue included $16.4 million from milestones and ongoing research and development services, $0.2 million in royalty revenue following the U.S. commercial launch, and $4.3 million in product revenue related to REZZAYO shipments to Melinta and Mundipharma[3].

Cost Structure and Expenses

The company's research and development expenses decreased from $77.4 million in 2022 to $68.5 million in 2023, primarily due to lower clinical expenses associated with the rezafungin trials. Selling, general, and administrative (SG&A) expenses also decreased from $20.5 million in 2022 to $18.3 million in 2023, reflecting lower consulting, personnel, and legal costs[3].

Cash and Cash Equivalents

As of December 31, 2023, Cidara's cash and cash equivalents totaled $35.8 million, compared to $32.7 million at the end of 2022. This increase is partly due to the milestone payments received from Mundipharma[3].

Partnerships and Collaborations

Melinta and Mundipharma Partnerships

Cidara has strategic partnerships with Melinta for the U.S. market and Mundipharma for markets outside the U.S. and Japan. These partnerships are crucial for the global commercialization of REZZAYO and have contributed to the company's revenue through milestone payments and product shipments[2][3].

Janssen Collaboration

Cidara also has a collaboration with Janssen for the development of CD388, a program aimed at the universal prevention of influenza A and B. This collaboration further validates the potential of Cidara's clinical programs and provides additional revenue streams through research and development services[2].

Future Outlook

Global Market Reach

The completion of enrollment in the Phase 3 ReSTORE trial in China and the ongoing approvals in various regions indicate that REZZAYO is on track to become a globally available treatment option. This expanded market reach is expected to increase revenue streams and solidify Cidara's market position[3].

Cloudbreak Platform Advancement

The milestone payments from Mundipharma will advance Cidara’s Cloudbreak platform, which is focused on developing drug-Fc conjugate (DFC) immunotherapies. This platform holds promise for targeted immunotherapies, particularly in oncology, with CBO421 being a lead candidate[5].

Key Takeaways

• Market Approval: REZZAYO has received approvals in the U.S., EU, and UK, marking significant milestones in its commercialization.
• Financial Benefits: Milestone payments and revenue from product shipments have contributed to Cidara's financial growth.
• Market Penetration: The drug addresses a treatment gap and offers a convenient dosing regimen, likely increasing adoption rates.
• Partnerships: Strategic partnerships with Melinta and Mundipharma are crucial for global commercialization.
• Future Outlook: Expanded market reach and advancements in the Cloudbreak platform are expected to drive long-term revenue growth.

FAQs

What is REZZAYO and what is it used for?

REZZAYO is a novel once-weekly echinocandin antifungal drug approved for the treatment of candidemia and invasive candidiasis in adults.

Who are the key partners for REZZAYO's commercialization?

Cidara Therapeutics has partnerships with Melinta for the U.S. market and Mundipharma for markets outside the U.S. and Japan.

What are the significant financial milestones for REZZAYO?

Cidara received milestone payments of $11.1 million and $2.8 million from Mundipharma for the EU and UK approvals, respectively.

How does REZZAYO compare to existing antifungal treatments?

REZZAYO offers a convenient weekly dosing regimen and has shown non-inferiority to the standard of care, caspofungin, in clinical trials.

What is the current financial status of Cidara Therapeutics?

As of December 31, 2023, Cidara's cash and cash equivalents totaled $35.8 million, with a net loss of $22.9 million for the full year.

Sources

1. Grand View Research: Antifungal Drugs Market Size, Share & Growth Report, 2030.
2. Cidara Therapeutics: Corporate Update and Reports Third Quarter 2023 Financial Results.
3. BioSpace: Cidara Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results.
4. StockTitan: Cidara Therapeutics Announces Approval of REZZAYO by the MHRA for the Treatment of Invasive Candidiasis in Adults.
5. Cidara Therapeutics: Receives $11.14 Million Milestone Payment Following European Approval of REZZAYO.