CASPOFUNGIN ACETATE - Generic Drug Details

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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

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Glossary

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

Expired US Patents for CASPOFUNGIN ACETATE

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

International Patents for CASPOFUNGIN ACETATE

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Country	Patent Number	Title	Estimated Expiration
San Marino	T201600452	FORMULAZIONI DI CASPOFUNGIN ACETATO	⤷ Sign Up
Hungary	E032392		⤷ Sign Up
Poland	2922530		⤷ Sign Up
Slovenia	2922530		⤷ Sign Up
Croatia	P20161703		⤷ Sign Up
Cyprus	1120016		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CASPOFUNGIN ACETATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0620232	C300076	Netherlands	⤷ Sign Up	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	44/2001	Austria	⤷ Sign Up	PRODUCT NAME: CASPOFUNGIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE CASPOFUNGINACETAT; REGISTRATION NO/DATE: EU/01/196/001-003 20011024
0620232	2001/029	Ireland	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: CASPOFUNGIN ACETATE; REGISTRATION NO/DATE: EU/1/01/196/001 20011024
0620232	SPC/GB02/002	United Kingdom	⤷ Sign Up	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.
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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