CASPOFUNGIN ACETATE - Generic Drug Details

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

Caspofungin acetate is the generic ingredient in two branded drugs marketed by Merck, Areva Pharms, Cipla, Fresenius Kabi Usa, Gland, Hangzhou Zhongmei, Hengrui Pharma, Pharmobedient, and Xellia Pharms Aps, and is included in nine NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Caspofungin acetate has fourteen patent family members in fourteen countries.

There are six drug master file entries for caspofungin acetate. Eight suppliers are listed for this compound.

Summary for CASPOFUNGIN ACETATE

International Patents:	14
US Patents:	1
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	20
Patent Applications:	959
Drug Prices:	Drug price trends for CASPOFUNGIN ACETATE
What excipients (inactive ingredients) are in CASPOFUNGIN ACETATE?	CASPOFUNGIN ACETATE excipients list
DailyMed Link:	CASPOFUNGIN ACETATE at DailyMed

See drug prices for CASPOFUNGIN ACETATE

Recent Clinical Trials for CASPOFUNGIN ACETATE

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

Sponsor	Phase
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Phase 4
European Organisation for Research and Treatment of Cancer - EORTC	Phase 3
Children's Oncology Group	Phase 3

See all CASPOFUNGIN ACETATE clinical trials

Pharmacology for CASPOFUNGIN ACETATE

Drug Class

Echinocandin Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for CASPOFUNGIN ACETATE

J02AX	Other antimycotics for systemic use
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for CASPOFUNGIN ACETATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CANCIDAS	for Injection	caspofungin acetate	50 mg/vial and 70 mg/vial	021227	1	2009-06-26

US Patents and Regulatory Information for CASPOFUNGIN ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xellia Pharms Aps	CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	205923-001	Jul 2, 2018		DISCN	No	No
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227-001	Jan 26, 2001		DISCN	Yes	No
Gland	CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	207092-002	Sep 29, 2017	AP	RX	No	No
Xellia Pharms Aps	CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	205923-002	Jul 2, 2018		DISCN	No	No
Hengrui Pharma	CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	200833-001	Jun 28, 2018	AP	RX	No	Yes
Pharmobedient	CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	207650-001	Sep 29, 2017		DISCN	No	No
Fresenius Kabi Usa	CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	206110-001	Dec 30, 2016	AP	RX	No	No			Y

Expired US Patents for CASPOFUNGIN ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227-002	Jan 26, 2001
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227-001	Jan 26, 2001
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227-002	Jan 26, 2001
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227-002	Jan 26, 2001
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227-002	Jan 26, 2001
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227-001	Jan 26, 2001
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227-002	Jan 26, 2001

International Patents for CASPOFUNGIN ACETATE

Country	Patent Number	Title	Estimated Expiration
Canada	2888625	COMPOSITIONS D'ACETATE DE CASPOFUNGINE (CASPOFUNGIN ACETATE FORMULATIONS)
Lithuania	2922530
Slovenia	2922530
World Intellectual Property Organization (WIPO)	2014081443
Hong Kong	1215668	醋酸卡泊芬淨製劑 (CASPOFUNGIN ACETATE FORMULATIONS)
Portugal	2922530
San Marino	T201600452	FORMULAZIONI DI CASPOFUNGIN ACETATO

Supplementary Protection Certificates for CASPOFUNGIN ACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0620232	2001/029	Ireland		PRODUCT NAME: CASPOFUNGIN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY CASPOFUNGIN ACETATE; REGISTRATION NO/DATE: EU/1/01/196/001-003 20011024; PAEDIATRIC INV. PLAN: P/30/2008
0620232	01C0054	France		PRODUCT NAME: CASPOFUNGIN ACETATE; REGISTRATION NO/DATE: EU/1/01/196/001 20011024
0620232	44/2001	Austria		PRODUCT NAME: CASPOFUNGIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE CASPOFUNGINACETAT; REGISTRATION NO/DATE: EU/01/196/001-003 20011024
0620232	C300076	Netherlands		PRODUCT NAME: CASPOFUNGINE, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT, IN HET BIJZONDER CASPOFUNGINE ACETAAT; REGISTRATION NO/DATE: EU/1/01/196/001-003 20011024
0620232	SPC/GB02/002	United Kingdom		A SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB02/002 GRANTED TO MERCK SHARP + DOHME, CORP IN RESPECT OF THE PRODUCT CASPOFUNGIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY CASPOFUNGIN ACETATE, WHICH WAS ADVERTISED AS COMING INTO FORCE IN JOURNAL NO 5919 DATED 30 OCTOBER 2002 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, IT WILL EXPIRE ON 24 OCTOBER 2016.

Market Dynamics and Financial Trajectory for Caspofungin Acetate

Last updated: July 27, 2025

Introduction

Caspofungin acetate, a frontline antifungal medication, has established itself as a vital therapeutic agent against invasive fungal infections, notably candidiasis and aspergillosis. Since its introduction, understanding the market dynamics and financial trajectory of caspofungin acetate is crucial for stakeholders ranging from pharmaceutical companies to healthcare providers. This analysis delineates recent industry trends, competitive landscape, regulatory influences, and revenue projections shaping the future of caspofungin acetate.

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Market Overview

Caspofungin acetate was developed by Merck & Co. (known as MSD outside the U.S. and Canada) and gained FDA approval in 2001. As an echinocandin class antifungal, it operates by inhibiting β-glucan synthesis, essential for fungal cell wall integrity. Its broad spectrum activity positions it as a critical option in treating life-threatening systemic fungal infections, particularly in immunocompromised patients, including transplant recipients and cancer patients.

According to industry reports, the global antifungal market, valued at approximately USD 10 billion in 2021, is projected to grow at a CAGR of 4-6% through 2028, driven by increasing incidence of invasive fungal infections and expanding immunocompromised populations. Caspofungin's share within this expanding market sustains robust demand, supported by its efficacy and a relatively favorable safety profile compared to older agents like amphotericin B.

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Market Dynamics Influencing Caspofungin Acetate

1. Epidemiological Drivers

The rising prevalence of invasive fungal infections (IFIs) correlates with increased survival rates in immunocompromised patients. Oncology, transplant medicine, and intensive care are sectors significantly impacted. The number of solid organ transplant procedures globally grew by approximately 5% annually, boosting the need for potent antifungal agents such as caspofungin [1].

2. Competitive Landscape

The antifungal market features key players: Merck (original developer), Pfizer, Basilea Pharmaceutica, and F2G Ltd. The primary competitors include other echinocandins like micafungin and anidulafungin. Biosimilars and generic versions of these agents are entering markets in regions with patent expirations, exerting downward pressure on prices.

However, caspofungin maintains; a competitive advantage due to its established clinical data and widespread clinician familiarity. The recent approval of various formulations and combination therapies enhances its market positioning.

3. Regulatory and Patent Environment

Merck’s patent for caspofungin in many regions expired around 2017-2018, opening the door for generic manufacturers. Generic entries generally lead to significant price reductions, impacting revenue streams for originators. Nonetheless, distribution agreements, brand loyalty, and clinical preferences sustain caspofungin’s profitability in several markets.

4. Pricing Strategies and Reimbursements

Pricing remains pivotal. Developed markets like the US and Europe typically offer higher reimbursement rates, maintaining revenue margins. Conversely, in emerging markets, price sensitivity and regulatory price controls challenge profitability, compelling companies to adopt tiered pricing or licensing agreements.

5. Research and Development Trends

Continued R&D efforts focus on expanding indications, improving formulations, and developing combination regimens. New delivery methods, such as liposomal formulations, aim to enhance bioavailability and reduce adverse effects, further consolidating market share.

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Financial Trajectory and Revenue Projections

1. Historical Revenue Analysis

Merck reported global sales of caspofungin at approximately USD 700 million in fiscal year 2021, primarily derived from North America and Europe [2]. Sales performance reflects the product’s clinical utility, with growth driven by increased fungal infection diagnoses.

2. Impact of Patent Expiry and Generics

Post-patent expiration, generic versions entered major markets by 2019-2020. Data indicates a decline of approximately 15-20% in branded caspofungin revenue during this transition, aligning with typical patterns in pharmaceutical patent cliffs.

3. Forecasted Revenue Trends

Analysts project an average annual decline of 4-6% in US and European markets attributable to generics, countered by emerging markets' growth, which compensates partially. New formulations and expanded clinical indications could offset decline rates by 2025.

In the long term (2023-2028), projections suggest stable revenues in developed countries with incremental growth in Asia-Pacific, Latin America, and the Middle East, driven by rising healthcare access and infection prevalence.

4. Market Expansion Opportunities

The increasing adoption of prophylactic antifungal therapies in oncology and transplant protocols presents upside potential. Additionally, strategic licensing and partnership agreements in emerging markets could bolster sales.

5. Operational Cost Considerations

Manufacturing costs for caspofungin are optimized through scalable fermentation processes. However, fluctuating raw material prices and regulatory compliance expenses influence profit margins.

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Strategic Implications for Stakeholders

Pharmaceutical companies must address patent expiries proactively, either by developing next-generation echinocandins, investing in biosimilars, or expanding indication portfolios. Clinicians and payers are increasingly favoring cost-effective generic options; thus, differentiation strategies underline the importance of clinical efficacy and pricing.

Market penetration into emerging economies necessitates adaptable pricing strategies and local partnerships. Continued innovation in formulations and combination therapies may sustain demand and profitability despite patent expiries.

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Key Takeaways

• Market Expansion Driven by Demographics: The growing immunocompromised patient base sustains demand for caspofungin, especially in developed regions.

• Patent Dynamics: Expiration of patents has led to price erosion and increased generic competition, impacting revenues but also expanding access.

• Regional Variations: Developed markets maintain higher prices due to reimbursement mechanisms; emerging markets offer growth opportunities with suitable pricing strategies.

• Innovation and Portfolio Diversification: R&D investments in formulations, new uses, and combination therapies are vital for maintaining market relevance amid evolving competitive landscapes.

• Regulatory Landscape: Tightening approval standards and patent strategies influence future product development and lifecycle management.

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Frequently Asked Questions

1. How has patent expiration affected caspofungin’s market share?
Patent expiration around 2017-2018 facilitated generic entry, leading to decreased prices and a reduction in branded sales by approximately 15-20%, though clinical preference and established efficacy maintain steady utilization in key markets.

2. What are the primary competitors to caspofungin?
Micafungin and anidulafungin are the main echinocandin competitors. Additionally, azole antifungals like voriconazole are alternative treatments for certain fungal infections.

3. How is the rise of biosimilars impacting the antifungal market?
Biosimilars are gradually entering markets with lower-cost options, pressuring the pricing of branded echinocandins and emphasizing the need for differentiation through clinical outcomes and formulation improvements.

4. What emerging markets show promise for caspofungin growth?
Asia-Pacific, Latin America, and the Middle East demonstrate significant growth potential due to expanding healthcare infrastructure, increased healthcare access, and rising incidence rates of invasive fungal infections.

5. What future innovations could influence caspofungin’s financial outlook?
Next-generation formulations, combination therapies, and expanded indications—such as prophylactic uses—are expected to enhance clinical utility and sustain revenue streams.

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Conclusion

Caspofungin acetate remains a critical component in the antifungal therapeutic landscape, navigating a complex market characterized by patent expiries, emerging competition, and evolving regional dynamics. While challenges in maintaining profit margins exist, opportunities for growth persist through innovation, strategic partnerships, and expanding indications. Stakeholders must monitor epidemiological trends, regulatory policies, and competitive actions to optimize the financial trajectory of caspofungin in the coming years.

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Sources

[1] Global Observatory on Health, Transplant Statistics 2022.
[2] Merck & Co. Annual Report 2021.