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Last Updated: March 2, 2021

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CASPOFUNGIN ACETATE Drug Profile

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Which patents cover Caspofungin Acetate, and when can generic versions of Caspofungin Acetate launch?

Caspofungin Acetate is a drug marketed by Cipla, Fresenius Kabi Usa, Gland Pharma Ltd, Jiangsu Hengrui Med, Mylan Labs Ltd, and Xellia Pharms Aps. and is included in six 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.

US ANDA Litigation and Generic Entry Outlook for Caspofungin Acetate

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

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Drug patent expirations by year for CASPOFUNGIN ACETATE
Drug Prices for CASPOFUNGIN ACETATE

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Recent Clinical Trials for CASPOFUNGIN ACETATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
European Organisation for Research and Treatment of Cancer - EORTCPhase 3
Children's Oncology GroupPhase 3
Merck Sharp & Dohme Corp.Phase 3

See all CASPOFUNGIN ACETATE clinical trials

Pharmacology for CASPOFUNGIN ACETATE
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 209489-001 Jul 12, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Jiangsu Hengrui Med CASPOFUNGIN ACETATE caspofungin acetate POWDER;INTRAVENOUS 200833-001 Jun 28, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa CASPOFUNGIN ACETATE caspofungin acetate POWDER;INTRAVENOUS 206110-002 Dec 30, 2016 AP RX No No   Start Trial   Start Trial Y   Start Trial
Xellia Pharms Aps CASPOFUNGIN ACETATE caspofungin acetate POWDER;INTRAVENOUS 205923-002 Jul 2, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Jiangsu Hengrui Med CASPOFUNGIN ACETATE caspofungin acetate POWDER;INTRAVENOUS 200833-002 Jun 28, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Cipla CASPOFUNGIN ACETATE caspofungin acetate POWDER;INTRAVENOUS 209489-002 Jul 12, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa CASPOFUNGIN ACETATE caspofungin acetate POWDER;INTRAVENOUS 206110-001 Dec 30, 2016 AP RX No No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for CASPOFUNGIN ACETATE

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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Johnson and Johnson
Medtronic
Express Scripts
McKesson

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