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Serving leading biopharmaceutical companies globally:

UBS
Chinese Patent Office
Novartis
QuintilesIMS
Chubb
Baxter
US Department of Justice
Deloitte
Citi
Daiichi Sankyo

Generated: February 21, 2018

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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 caspofungin acetate freedom to operate?

Caspofungin acetate
is the generic ingredient in two branded drugs marketed by Merck, Fresenius Kabi Usa, Gland Pharma Ltd, and Mylan Labs Ltd, and is included in four 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 thirteen patent family members in thirteen countries.

There are eight drug master file entries for caspofungin acetate. Six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for caspofungin acetate
Pharmacology for caspofungin acetate
Ingredient-typeLipopeptides
Drug ClassEchinocandin Antifungal
Tentative approvals for CASPOFUNGIN ACETATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up50MG/VIALINJECTABLE; INJECTION
➤ Sign Up➤ Sign Up70MG/VIALINJECTABLE; INJECTION

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
Fresenius Kabi Usa CASPOFUNGIN ACETATE caspofungin acetate POWDER;IV (INFUSION) 206110-002 Dec 30, 2016 AP RX No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Fresenius Kabi Usa CASPOFUNGIN ACETATE caspofungin acetate POWDER;IV (INFUSION) 206110-001 Dec 30, 2016 AP RX No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gland Pharma Ltd CASPOFUNGIN ACETATE caspofungin acetate POWDER;IV (INFUSION) 207092-002 Sep 29, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Labs Ltd CASPOFUNGIN ACETATE caspofungin acetate POWDER;IV (INFUSION) 207650-001 Sep 29, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck CANCIDAS caspofungin acetate POWDER;IV (INFUSION) 021227-002 Jan 26, 2001 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gland Pharma Ltd CASPOFUNGIN ACETATE caspofungin acetate POWDER;IV (INFUSION) 207092-001 Sep 29, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Labs Ltd CASPOFUNGIN ACETATE caspofungin acetate POWDER;IV (INFUSION) 207650-002 Sep 29, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck CANCIDAS caspofungin acetate POWDER;IV (INFUSION) 021227-001 Jan 26, 2001 AP RX Yes Yes ➤ 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

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Expired US Patents for caspofungin acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck CANCIDAS caspofungin acetate POWDER;IV (INFUSION) 021227-001 Jan 26, 2001 ➤ Sign Up ➤ Sign Up
Merck CANCIDAS caspofungin acetate POWDER;IV (INFUSION) 021227-001 Jan 26, 2001 ➤ Sign Up ➤ Sign Up
Merck CANCIDAS caspofungin acetate POWDER;IV (INFUSION) 021227-002 Jan 26, 2001 ➤ Sign Up ➤ Sign Up
Merck CANCIDAS caspofungin acetate POWDER;IV (INFUSION) 021227-001 Jan 26, 2001 ➤ Sign Up ➤ Sign Up
Merck CANCIDAS caspofungin acetate POWDER;IV (INFUSION) 021227-002 Jan 26, 2001 ➤ Sign Up ➤ Sign Up
Merck CANCIDAS caspofungin acetate POWDER;IV (INFUSION) 021227-002 Jan 26, 2001 ➤ Sign Up ➤ Sign Up
Merck CANCIDAS caspofungin acetate POWDER;IV (INFUSION) 021227-002 Jan 26, 2001 ➤ Sign Up ➤ Sign Up
Merck CANCIDAS caspofungin acetate POWDER;IV (INFUSION) 021227-002 Jan 26, 2001 ➤ Sign Up ➤ Sign Up
Merck CANCIDAS caspofungin acetate POWDER;IV (INFUSION) 021227-001 Jan 26, 2001 ➤ Sign Up ➤ Sign Up
Merck CANCIDAS caspofungin acetate POWDER;IV (INFUSION) 021227-001 Jan 26, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for caspofungin acetate

Supplementary Protection Certificates for caspofungin acetate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/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.
/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
00076 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
C0054 France ➤ Sign Up PRODUCT NAME: CASPOFUNGIN ACETATE; REGISTRATION NO/DATE: EU/1/01/196/001 20011024
01/029 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Citi
Moodys
QuintilesIMS
Argus Health
Fish and Richardson
UBS
Johnson and Johnson
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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