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Caspofungin acetate - Generic Drug Details

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What are the generic sources for caspofungin acetate and what is the scope of patent protection?

Caspofungin acetate is the generic ingredient in two branded drugs marketed by Merck, Cipla, Fresenius Kabi Usa, Gland Pharma Ltd, Jiangsu Hengrui Med, Mylan Labs Ltd, and Xellia Pharms Aps, and is included in seven 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 eight 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:	7
NDAs:	7
Drug Master File Entries:	8
Suppliers / Packagers:	8
Bulk Api Vendors:	45
Clinical Trials:	14
Patent Applications:	645
Formulation / Manufacturing:	see details
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
European Organisation for Research and Treatment of Cancer - EORTC	Phase 3
Children's Oncology Group	Phase 3
Merck Sharp & Dohme Corp.	Phase 3

See all caspofungin acetate clinical trials

Pharmacology for caspofungin acetate

Drug Class

Echinocandin Antifungal

Paragraph IV (Patent) Challenges for CASPOFUNGIN ACETATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
CANCIDAS	POWDER;INTRAVENOUS	caspofungin acetate	021227	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
Cipla	CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	209489-002	Jul 12, 2018		DISCN	No	No
Gland Pharma Ltd	CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	207092-001	Sep 29, 2017	AP	RX	No	No
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227-001	Jan 26, 2001	AP	RX	Yes	Yes

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	021227-001	Jan 26, 2001

International Patents for caspofungin acetate

Country	Patent Number	Estimated Expiration
European Patent Office	2922530
Hong Kong	1215668
Canada	2888625

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	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