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, Hengrui Pharma, Norvium Bioscience, and Xellia Pharms Aps, and is included in eight 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:	8
NDAs:	8
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	20
Patent Applications:	1,198
Drug Prices:	Drug price trends for CASPOFUNGIN ACETATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
Norvium Bioscience	CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	207650-002	Sep 29, 2017		DISCN	No	No
Areva Pharms	CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	211263-002	Oct 1, 2021	AP	RX	No	No
Norvium Bioscience	CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	207650-001	Sep 29, 2017		DISCN	No	No
Cipla	CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	209489-001	Jul 12, 2018		DISCN	No	No
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227-001	Jan 26, 2001	AP	RX	Yes	Yes
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	021227-001	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	021227-001	Jan 26, 2001

International Patents for CASPOFUNGIN ACETATE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2014081443
San Marino	T201600452	FORMULAZIONI DI CASPOFUNGIN ACETATO
European Patent Office	2922530	COMPOSITIONS D'ACÉTATE DE CASPOFUNGINE (CASPOFUNGIN ACETATE FORMULATIONS)
Slovenia	2922530
Canada	2888625	COMPOSITIONS D'ACETATE DE CASPOFUNGINE (CASPOFUNGIN ACETATE FORMULATIONS)
Hong Kong	1215668	醋酸卡泊芬淨製劑 (CASPOFUNGIN ACETATE FORMULATIONS)
Hungary	E032392

Supplementary Protection Certificates for CASPOFUNGIN ACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	01C0054	France		PRODUCT NAME: CASPOFUNGIN ACETATE; REGISTRATION NO/DATE: EU/1/01/196/001 20011024
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	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

CASPOFUNGIN ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Caspofungin Acetate

Introduction to Caspofungin Acetate

Caspofungin acetate, marketed as Cancidas by Merck Sharp & Dohme (U.S.), is a pioneering antifungal drug belonging to the echinocandin class. It has been approved for use in patients with invasive aspergillosis who are refractory to or intolerant of conventional therapy, as well as for treating candidiasis and other fungal infections[5].

Global Market Size and Growth

The global caspofungin market has shown a steady, albeit modest, growth trajectory. In 2018, the market was valued at US$ 484.60 million and is projected to reach US$ 496.20 million by 2027, growing at a Compound Annual Growth Rate (CAGR) of 0.18% from 2019 to 2027[1].

However, more recent projections suggest a slightly more optimistic outlook. By 2023, the market size had increased to USD 471.57 million and is expected to grow at a CAGR of 1.9% from 2024 to 2030[3].

Key Drivers of Market Growth

Several factors are driving the growth of the caspofungin market:

• Rise in Prevalence of Fungal Diseases: The increasing incidence of candidiasis, particularly among individuals with advanced HIV infection and the elderly, is a significant driver. For instance, the CDC reported that over one-third of people with advanced HIV infection also had oral and throat candidiasis[3].
• Growing Geriatric Population: The rise in the geriatric population, who are more susceptible to candidemia and severe aspergillosis, is another key factor[3].
• Public Awareness and Preventive Measures: Increased public awareness about preventive measures for various microbial infections has also contributed to the market growth[1][3].
• COVID-19 Pandemic Impact: Although the COVID-19 pandemic disrupted healthcare systems, it also highlighted the need for effective antifungal therapies, including caspofungin, especially in patients with severe COVID-19 and underlying hematological conditions[3].

Regional Market Analysis

The global caspofungin market is segmented into several regions:

• North America and Europe: These regions accounted for the leading shares of the global market in 2018, driven by a large patient population and the presence of major pharmaceutical companies. The rise in prevalence of fungal diseases and the growing geriatric population in these regions further fuel the market[1].
• Asia Pacific: This region is expected to expand at a high CAGR due to rapidly improving healthcare facilities in countries like India, China, South Korea, and Malaysia. China dominated the caspofungin market in Asia Pacific in 2018, and India is anticipated to grow significantly during the forecast period[1].
• Latin America and Middle East & Africa: These regions are expected to expand at a steady pace during the forecast period[1].

Market Segmentation

The caspofungin market is segmented based on several criteria:

• Indication: The market is primarily segmented into candidiasis, thrush, and other indications. Candidiasis holds the largest market share due to its high prevalence, especially among the elderly and those with compromised immune systems[3].
• Distribution Channel: The market is also segmented by distribution channels, including hospitals, clinics, and retail pharmacies[1].

Competitive Landscape

The global caspofungin market is competitive, with several key players:

• Merck & Co., Inc.: As the original developer and marketer of caspofungin, Merck holds a significant position.
• Teva Pharmaceutical Industries Ltd.: Known for its generic offerings, Teva is a major player.
• Mylan N.V: Another significant generic drug manufacturer.
• Fresenius SE & Co. KGaA: A global healthcare company with a diverse portfolio.
• Gland Pharma Limited: An Indian pharmaceutical company with a strong presence in the generics market.
• Xellia Pharmaceuticals: Specializes in the development and manufacture of anti-infective treatments[1].

Financial Performance and Investments

The financial performance of the caspofungin market is influenced by various factors, including research and development investments and market dynamics.

• Research and Development: Companies like Cidara Therapeutics are investing heavily in clinical trials and research for new antifungal agents. For example, Cidara's rezafungin program involves significant R&D expenses, which were $9.2 million and $32.6 million for the three and nine months ended September 30, 2017, respectively[2].
• Market Revenue: The market revenue is expected to grow, driven by the increasing demand for effective antifungal therapies. However, the growth rate is modest, reflecting the competitive and somewhat saturated nature of the market[1][3].

Challenges and Opportunities

• Antifungal Resistance: The increasing focus on antifungal resistance presents both a challenge and an opportunity for the development of new and more effective antifungal agents[4].
• Generic Competition: The introduction of generic versions of caspofungin by companies like Teva and Mylan can impact the market share of branded products but also expands access to the drug[1].
• Partnerships and Collaborations: Partnerships in the pharmaceutical sector to develop new antifungal therapies can drive innovation and growth in the market[4].

Key Takeaways

• The global caspofungin market is driven by the rise in fungal infections, growing geriatric population, and public awareness.
• North America and Europe dominate the market, while Asia Pacific is expected to grow rapidly.
• The market is segmented by indication, with candidiasis being the largest segment.
• Key players include Merck, Teva, Mylan, and others.
• Financial performance is influenced by R&D investments and market dynamics.

FAQs

Q: What is caspofungin acetate used for? A: Caspofungin acetate is used to treat invasive aspergillosis and candidiasis, including esophageal candidiasis and candidemia.

Q: Which regions dominate the caspofungin market? A: North America and Europe currently dominate the caspofungin market due to a large patient population and the presence of major pharmaceutical companies.

Q: How has the COVID-19 pandemic affected the caspofungin market? A: The COVID-19 pandemic has increased the demand for caspofungin due to the higher incidence of fungal co-infections in COVID-19 patients, especially those with underlying hematological conditions.

Q: Who are the key players in the caspofungin market? A: Key players include Merck & Co., Inc., Teva Pharmaceutical Industries Ltd., Mylan N.V, Fresenius SE & Co. KGaA, Gland Pharma Limited, and Xellia Pharmaceuticals.

Q: What is the expected growth rate of the caspofungin market from 2024 to 2030? A: The global caspofungin market is expected to grow at a CAGR of 1.9% from 2024 to 2030.

Cited Sources

1. Transparency Market Research - Caspofungin Market | Global Analysis Report 2027
2. Cidara Therapeutics - Cidara Provides Corporate Update and Reports Third Quarter 2017 Financial Results
3. Grand View Research - Caspofungin Market Size, Share And Growth Report, 2030
4. Market Research Intellect - Caspofungin Acetate Market Takes Center Stage in the Battle Against Fungal Diseases
5. PubMed - Safety and tolerability of caspofungin acetate in the treatment of fungal infections.