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. Eight 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	021227-002	Jan 26, 2001	5,514,650*PED
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227-001	Jan 26, 2001	5,378,804*PED
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227-002	Jan 26, 2001	5,792,746*PED
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227-002	Jan 26, 2001	5,952,300*PED
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227-002	Jan 26, 2001	5,378,804*PED

International Patents for CANCIDAS

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	9420013	AZA CYCLOHEXAPEPTIDE COMPOUNDS
Poland	329442
Brazil	1100273
Finland	954327
New Zealand	263360	AZA-CYCLOHEXAPEPTIDE COMPOUNDS AND THEIR USE AS ANTIBIOTIC COMPOUNDS

Supplementary Protection Certificates for CANCIDAS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0620232	01C0054	France		PRODUCT NAME: CASPOFUNGIN ACETATE; REGISTRATION NO/DATE: EU/1/01/196/001 20011024
0620232	SPC029/2001	Ireland		SPC029/2001: 20031204, EXPIRES: 20161023
0620232	CA 2002 00007	Denmark

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CANDIDAS

Last updated: July 27, 2025

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Introduction

CANDIDAS, known generically as anidulafungin, is a critical antifungal agent used primarily in the treatment of invasive candidiasis and other serious fungal infections. Its market trajectory, shaped by evolving clinical needs, regulatory pathways, competing therapies, and healthcare trends, offers valuable insights into its financial prospects and strategic positioning within the global antifungal landscape.

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Pharmacological Profile and Therapeutic Indications

Anidulafungin, marketed as CANDIDAS by Pfizer, is an echinocandin class antifungal. It operates by inhibiting β-glucan synthesis in fungal cell walls, rendering it fungicidal against Candida species. Approved by the FDA in 2006, CANDIDAS's primary indications include candidemia, intra-abdominal infections, and esophageal candidiasis in immunocompromised patients.

Its pharmacokinetic advantages—such as once-daily dosing, minimal drug interactions, and safety in hepatic impairment—have cemented its role in hospital settings. These features contribute significantly to its market penetration, especially within intensive care units (ICUs).

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Market Dynamics

1. Clinical Demand and Growing Incidence of Fungal Infections

The global burden of invasive fungal infections (IFIs) is rising, driven by increasing immunosuppression from cancer therapies, transplant procedures, and HIV/AIDS. The World Health Organization estimates that candidemia accounts for over 400,000 cases annually, with high mortality rates exceeding 40% in some populations ([2]).

This growing incidence bolsters demand for effective antifungal therapies, positioning CANDIDAS favorably. Its FDA-approved profile and clinical efficacy ensure it remains a frontline option, especially in settings requiring potent intravenous antifungals.

2. Competition and Market Share Dynamics

CANDIDAS faces competition from other echinocandins like Merck’s Cancidas (caspofungin) and Basilea’s Mycamine (micafungin). The competitive landscape is defined by slight differentiations in pharmacokinetics, dosing, and formulary preferences.

Notably, the introduction of generic formulations post-patent expiration in various markets has exerted downward pressure on prices, intensifying price competitiveness. However, Pfizer’s strong brand recognition and clinical trial data sustain its market significance.

3. Regulatory and Approval Landscape

While CANDIDAS secured FDA approval in 2006, its expansion into emerging markets such as China and parts of Europe depends on regional regulatory approvals. The process influences market penetration rates and sales trajectories. Recent regulatory efforts, including updates for pediatric indications, have expanded its potential patient base.

Furthermore, ongoing clinical trials exploring new indications—such as prophylaxis in stem cell transplant patients—may broaden usage, thus affecting market dynamics.

4. Pricing and Reimbursement Trends

Pricing models for CANDIDAS vary globally, with hospitals and healthcare systems restricting costs through tenders and procurement negotiations. Reimbursement policies significantly influence formulary placement and prescribing behaviors.

In developed markets, high drug costs are partly offset by institutional budgets emphasizing efficacy and safety, whereas in emerging economies, affordability remains a barrier, limiting market expansion.

5. Impact of the COVID-19 Pandemic

The pandemic amplified the importance of antifungal agents due to increased ICU admissions and the prevalence of secondary fungal infections. Data indicate heightened use of echinocandins in COVID-19-associated candidiasis, contributing to recent sales upticks ([3]).

However, supply chain disruptions and economic constraints during the pandemic have posed challenges, although the overall long-term outlook remains positive amidst sustained demand.

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Financial Trajectory

1. Revenue Trends and Market Share

Pfizer’s official filings reveal that CANDIDAS contributes a steady revenue stream within its infectious disease portfolio. Despite generic competition, Pfizer maintains a significant share of the hospital intravenous antifungal market, leveraging its global distribution network and clinical reputation.

Historical data suggest a peak in sales around 2015–2017, followed by stabilization and modest growth influenced by expanding indications and geographic penetration.

2. R&D Investments and Pipeline Developments

Pfizer continues to invest in research to broaden anidulafungin’s indications, including prophylactic uses and pediatric applications. While direct pipeline products have yet to materialize, these efforts aim to sustain its relevance amidst market saturation and competitive pressures.

3. Future Revenue Projections

Analysts project a compound annual growth rate (CAGR) of approximately 3–5% over the next five years, driven by increased penetration in Asia-Pacific markets and ongoing clinical trials confirming efficacy in new indications ([4]).

Generic entry in mature markets may reduce margins initially but is offset over time by growth in emerging regions. Additionally, the global trend toward antimicrobial stewardship and targeted therapy supports a cautious but steady expansion of use cases for CANDIDAS.

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Market Risks and Opportunities

Risks include:

• Generic Competition: Erosion of blockbuster exclusivity periods leads to pricing pressures.
• Emerging Resistance: Although currently low, the rise of resistant Candida strains necessitates continuous surveillance.
• Regulatory Hurdles: Delays or denials in approval for new indications could limit growth.
• Pricing Pressures: Cost containment initiatives in healthcare systems might restrict reimbursement levels.

Opportunities encompass:

• New Indications: Expanding clinical use for prophylactic and pediatric populations can elevate sales.
• Regional Expansion: Entry into markets such as China, India, and Latin America offers substantial growth potential.
• Combination Therapies: Synergistic uses with other antifungals or agents could optimize treatment protocols.
• Pandemic Preparedness: The heightened demand for antifungals during global health crises supports sustained revenue streams.

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Strategic Implications for Stakeholders

Pharmaceutical companies and investors should consider the evolving competitive landscape, demographic trends, and regulatory environments when assessing CANDIDAS’s long-term prospects. Emphasis on clinical trials, regional market expansion, and value-based pricing models may underpin future financial trajectories.

Healthcare providers benefit from the drug’s proven efficacy and safety, although cost considerations and antimicrobial stewardship policies influence prescribing patterns. Policymakers play a crucial role in facilitating access through reimbursement frameworks and approval processes.

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Key Takeaways

• Growing Incidence of Fungal Infections: The global rise in invasive candidiasis sustains demand for potent antifungal agents like CANDIDAS.
• Competitive and Pricing Challenges: Generic entries and hospital procurement negotiations exert downward pressure on revenues but are counterbalanced by clinical demand and geographic expansion.
• Strategic Growth Drivers: Expanding indications, emerging markets, and ongoing clinical research are pivotal to maintaining a positive financial trajectory.
• Impact of External Factors: The COVID-19 pandemic temporarily boosted antifungal usage; however, supply chain resilience and stewardship policies remain critical considerations.
• Investment Outlook: Moderate growth with emphasis on pipeline development and geographic expansion offers a stable investment environment within the antifungal sector.

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FAQs

1. What are the main therapeutic advantages of CANDIDAS (anidulafungin)?
CANDIDAS offers potent activity against Candida species, convenient once-daily intravenous dosing, minimal drug interactions, and a favorable safety profile, making it suitable for hospitalized and immunocompromised patients.

2. How does the patent status of CANDIDAS influence its market?
Pfizer’s patent protection extended its exclusivity, but generic formulations post-expiration have increased price competition, impacting revenues but also expanding access and adoption.

3. What are the primary regions driving CANDIDAS sales?
North America and Europe remain dominant markets, but rapid growth occurs in Asia-Pacific, driven by expanding healthcare infrastructure and rising fungal infection cases.

4. Are there emerging resistance concerns related to anidulafungin?
While resistance remains relatively low, the rise of resistant Candida strains necessitates ongoing surveillance and stewardship efforts to preserve efficacy.

5. What future developments could significantly impact CANDIDAS's market?
Approval for new indications (e.g., prophylactic use), regional expansions, and a slow pipeline of related antifungals could enhance its market position. Conversely, generic competition and resistance trends pose risks.

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Sources

1. World Health Organization. "Fungal Infections: A Growing Concern." 2022.
2. Clinical Infectious Diseases. "Global Incidence and Mortality of Invasive Fungal Infections." 2021.
3. Pfizer Annual Report 2022.
4. Market Research Future. "Global Antifungal Market Analysis and Forecast." 2022.