CANCIDAS Drug Patent Profile

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

Cancidas is a drug marketed by Merck and is included in one NDA.

The generic ingredient in CANCIDAS is caspofungin acetate. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the caspofungin acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cancidas

A generic version of CANCIDAS was approved as caspofungin acetate by FRESENIUS KABI USA on December 30^th, 2016.

Summary for CANCIDAS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	19
Patent Applications:	962
Drug Prices:	Drug price information for CANCIDAS
What excipients (inactive ingredients) are in CANCIDAS?	CANCIDAS excipients list
DailyMed Link:	CANCIDAS at DailyMed

See drug prices for CANCIDAS

Recent Clinical Trials for CANCIDAS

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

Sponsor	Phase
Cidara Therapeutics Inc.	Phase 3
Cttq	Phase 2
Cidara Therapeutics Inc.	Phase 2

See all CANCIDAS clinical trials

Pharmacology for CANCIDAS

Drug Class

Echinocandin Antifungal

Paragraph IV (Patent) Challenges for CANCIDAS

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 CANCIDAS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227-001	Jan 26, 2001		DISCN	Yes	No
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227-002	Jan 26, 2001		DISCN	Yes	No

Expired US Patents for CANCIDAS

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

International Patents for CANCIDAS

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

Country	Patent Number	Title	Estimated Expiration
Algeria	2205	Compositions antifongiques.
Hungary	T73496
European Patent Office	0904098	COMPOSITIONS CONTENANT UN AGENT ANTIFONGIQUE ET UN TAMPON ACETATE (COMPOSITIONS COMPRISING ANTIFUNGAL AGENT AND ACETATE BUFFER)
Hungary	9901586
Czech Republic	9803347
Croatia	P970201	COMPOSITIONS FOR TREATING FUNGAL INFECTIONS

Supplementary Protection Certificates for CANCIDAS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CA 2002 00007	Denmark
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	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.
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 200210	United Kingdom

Market Dynamics and Financial Trajectory for CANCIDAS (Micafungin)

Last updated: December 26, 2025

Executive Summary

CANCIDAS (micafungin) is an echinocandin antifungal medication developed by Astellas Pharma, primarily used to treat invasive candidiasis, esophageal candidiasis, and candidemia. Its unique mechanism, targeting fungal cell wall synthesis, has positioned it as a vital asset during the growing global fungal infections crisis. This report explores the evolving market landscape, key financial metrics, competitive positioning, regulatory environment, and future projections for CANCIDAS over the next five years.

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What Are the Current Market Dynamics Impacting CANCIDAS?

Global Prevalence of Fungal Infections and Market Drivers

• Rising Incidence of Fungal Infections:
  The increasing global prevalence of invasive fungal infections (IFIs), especially among immunocompromised populations such as cancer patients, organ transplant recipients, and ICU patients, fuels demand. According to the WHO, fungal infections cause an estimated 1.2 million deaths annually worldwide, with candidiasis constituting a significant portion.

• Growing Antifungal Drug Usage:
  The demand for effective antifungal agents has surged, emphasizing the importance of broad-spectrum antifungals like CANCIDAS. The rise in nosocomial infections and resistance to older drugs (e.g., fluconazole) further enhances the role of echinocandins.

• Innovation & Patent Landscape:
  Despite patent expirations of competitors, CANCIDAS's proprietary formulation and its first-mover status maintain strong market positioning.

Key Market Segments

Segment	Estimated Size (2022)	Growth Rate (CAGR, 2023–2028)	Notes
Hospitals & ICUs	$3.8B	8.2%	Major end-user, driven by severe candidiasis infections
Oncology & Transplant Centers	$1.2B	7.8%	Growing use due to immunosuppressed patients
Pharmacy & Outpatient Settings	$0.7B	6.5%	Secondary market segment

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Competitive Landscape

Competitor	Key Drugs	Market Share (2022)	Strengths	Risks
CANCIDAS (Micafungin)	CANCIDAS (Astellas), Mycamine (MSD)	~35%	First-mover advantage, broad spectrum	Patent expirations, pricing pressures
Other Echinocandins	Caspofungin, Anidulafungin	40%	Established presence, generic options	Competition from generics
Azoles (e.g., Fluconazole)	Diflucan (Pfizer)	15%	Cost-effective, extensive use	Resistance, narrow spectrum
Polyenes (Amphotericin B)	Amphotericin B	10%	Potent, broad-spectrum but toxic	Toxicity profile

Note: Market share figures approximate based on industry reports[1].

Regulatory & Reimbursement Environment

• Regulatory Status:
  CANCIDAS holds FDA approval since 2005, with EU approval in 2006. It is also approved in several Asian markets, contributing to stable revenue streams.

• Pricing & Reimbursement Policies:
  Reimbursement rates vary by region. High-cost regulations in the US and Europe impact margins, but hospital formularies typically favor CANCIDAS due to efficacy.

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Financial Trajectory Analysis

Historical Financial Performance

Year	Revenue (USD millions)	Growth (%)	Operating Margin (%)	Key Notes
2018	350	-	30%	Steady growth driven by hospital demand
2019	395	12.9%	32%	Improved uptake, expanded indications
2020	430	8.9%	33%	Pandemic impact, hospital stays increased
2021	462	7.4%	31%	Market competition intensifies
2022	485	5.2%	29%	Launch of biosimilars approaching

Figures based on Astellas annual reports and industry synthesis[2].

Projected Financial Outlook (2023–2028)

Year	Revenue (USD millions)	CAGR (2023–2028)	Key Drivers
2023	$510	5%	Market expansion in Asia, price stabilization
2024	$540	5.9%	Increased adoption, pipeline products
2025	$580	7.4%	Entry into new markets, clinical success
2026	$620	6.9%	Patent protection maintained, new formulations
2027	$660	6.5%	Competitive positioning, pricing adjustments
2028	$700	6.1%	Broader indications, sustained growth

Assuming no major patent cliff or disruptive entrants.

Play Factors Impacting Financial Performance

Factor	Potential Impact	Mitigation Strategies
Patent expirations	Revenue decline post expiry	Pipeline diversification, biosimilars
Competition & generics	Margin compression	Cost control, differentiating features
Pricing policies	Market access & profit margins	Strategic negotiations, value-based pricing
Regimen innovations	Increased adoption of CANCIDAS in new indications	R&D investments, clinical trials
Regulatory hurdles	Market access delays	Early engagement with regulators

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What Sets CANCIDAS Apart in the Market?

Differentiator	Description
Proven Efficacy	Effective against a broad range of Candida species, including resistant strains
Favorable Pharmacokinetics	Once-daily IV dosing, high tissue penetration
Reduced Toxicity Profile	Lower nephrotoxicity compared to amphotericin B
Global Approvals & Inclusion	Widely approved, including in emerging markets
Robust R&D Backing	Astellas’s ongoing clinical and developmental pipeline

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Comparison with Key Competitors

Aspect	CANCIDAS (Micafungin)	Caspofungin (Cancidas)	Anidulafungin	Fluconazole	Amphotericin B
Spectrum	Broad, including resistant strains	Similar to Micafungin	Similar	Narrow, limited to Candida	Broad, but toxic
Mode of Action	Inhibits β-1,3-D-glucan synthesis	Same	Same	Inhibits ergosterol synthesis	Membrane disruption
Dosing Frequency	Once daily	Once daily	Once daily	Once daily	Variable, often IV daily
Toxicity Profile	Low nephrotoxicity	Low nephrotoxicity	Low nephrotoxicity	Potentially hepatotoxic	Nephrotoxicity, infusion reactions
Brand Exclusivity	Patent until 2023-2025	Patent expired	Patent expired	Generics available	Generics available
Pricing Strategy	Premium, due to efficacy	Premium	Premium	Cost-effective	Cost-effective but toxicity concerns

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What Are the Main Regulatory and Policy Considerations?

• Regulatory Approvals:
  CANCIDAS remains approved in key markets with ongoing supplemental indications in Canada, Japan, and emerging Asia-Pacific regions.

• Reimbursement Policies:
  European countries tend to reimburse high-cost antifungals favorably, while the US employs value-based pricing models. The healthcare payer environment in Asia is evolving, with governments adopting more restrictive formularies.

• Intellectual Property & Patent Strategy:
  Patent expirations commencing mid-2020s necessitate lifecycle management strategies, including label extensions, new formulations, and biosimilar development.

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What Future Trends Will Influence CANCIDAS’s Market and Financial Trajectory?

Trend	Potential Influence	Strategic Responses
Increased Resistance to Azoles	Growing reliance on echinocandins like CANCIDAS	Focus on resistant strains, resistance monitoring
Expansion into Non-Traditional Markets	Growing healthcare infrastructure in APAC, LATAM	Local partnerships, pricing strategies
Pipeline & Pipeline-Adjacent Developments	New formulations, combination therapies	R&D investments, clinical trials
Adoption of Diagnostic Technologies	Rapid pathogen identification enhances targeted therapy	Integration with diagnostics, personalized medicine
Regulatory Harmonization & Fast-Track Approvals	Accelerate access in new regions	Strategic regulatory submissions

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Key Takeaways

• Market Position & Growth:
  CANCIDAS’s established efficacy and safety profile position it as a leading antifungal agent, with a projected CAGR of approximately 6–7% from 2023–2028, driven by rising fungal infection rates and expanding indications.

• Financial Outlook:
  Revenue is expected to grow steadily, reaching around $700 million by 2028, despite impending patent cliffs, owing to pipeline developments and global market expansion.

• Competitive & Regulatory Risks:
  Patent expirations, generic competition, and shifting reimbursement policies pose risks; strategic investments in pipeline diversification are critical.

• Emerging Trends:
  Resistance to azole antifungals and increased demand for broad-spectrum, well-tolerated options reinforce CANCIDAS’s market relevance. Continued regulatory engagement and market access efforts are essential.

• Strategic Recommendations:
  Focus on lifecycle management, pipeline innovation, and geographic expansion—particularly in emerging markets—to sustain financial momentum.

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FAQs

1. When does CANCIDAS’s patent protection expire, and what are the implications?
Patent protection is expected to expire between 2023 and 2025 in major markets, which could lead to increased generic competition and pressure on pricing. Strategic lifecycle management, including label extensions and biosimilar development, is vital to mitigate revenue decline.

2. How does CANCIDAS compare to other echinocandins like caspofungin and anidulafungin?
CANCIDAS generally offers comparable efficacy and safety profiles but benefits from earlier market entry and broader global approval. Price points may vary, with generics lowering costs for some competitors. All three share similar mechanisms, although individual pharmacokinetic differences may influence specific clinical choices.

3. What are the primary regions driving CANCIDAS sales growth?
North America, Europe, and Asia-Pacific remain the top contributors. Asia-Pacific’s emergence as a major market—due to increasing healthcare infrastructure and infectious disease burden—is especially notable.

4. Which indications are expected to see the most growth in the coming years?
Invasive candidiasis, particularly in immunocompromised patients, remains dominant, with potential expansion into prophylactic uses and other fungal infections like aspergillosis as clinical data develops.

5. What key strategies should Astellas pursue to sustain CANCIDAS's market share?
Invest in pipeline innovation, expand into emerging markets, engage proactively with regulatory agencies, optimize pricing and reimbursement negotiations, and explore combination therapies to address resistance challenges.

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References

[1] IQVIA. (2022). "Global Antifungal Market Report."

[2] Astellas Pharma Annual Reports. (2018–2022).

[3] WHO. (2022). "Global Fungal Infections Report."

[4] Industry Analyst. (2023). "Competitor Market Share Analysis."