CASPOFUNGIN ACETATE Drug Patent Profile

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Caspofungin Acetate is a drug marketed by Areva Pharms, Cipla, Fresenius Kabi Usa, Gland, Hengrui Pharma, Norvium Bioscience, and Xellia Pharms Aps. and is included in seven NDAs. There is one patent protecting this drug.

This drug has fourteen patent family members in fourteen countries.

The generic ingredient in CASPOFUNGIN ACETATE 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.

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

International Patents:	14
US Patents:	1
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	20
Patent Applications:	775
Drug Prices:	Drug price information 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

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

Drug Class	Echinocandin Antifungal

J02AX	Other antimycotics for systemic use
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

CASPOFUNGIN ACETATE is protected by one US patents.

Caspofungin acetate formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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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
Areva Pharms	CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	211263-001	Oct 1, 2021	AP	RX	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
Cipla	CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	209489-002	Jul 12, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	207650-002	Sep 29, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland	CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	207092-002	Sep 29, 2017	AP	RX	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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

See the table below for patents covering CASPOFUNGIN ACETATE around the world.

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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

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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