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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Julphar
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Merck
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Generated: November 22, 2017

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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 Fresenius Kabi Usa, Merck, Mylan Labs Ltd, and Gland Pharma Ltd, and is included in four NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Caspofungin acetate has sixty-four patent family members in forty-two countries and five supplementary protection certificates in five countries.

There are eight drug master file entries for caspofungin acetate. Five suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for caspofungin acetate

Ingredient-typeLipopeptides
Drug ClassEchinocandin Antifungal

Tentative approvals for CASPOFUNGIN ACETATE

Applicant Application No. Strength Dosage Form
u► Subscribe50MG/VIALINJECTABLE; INJECTION
u► Subscribe70MG/VIALINJECTABLE; INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gland Pharma Ltd
CASPOFUNGIN ACETATE
caspofungin acetate
POWDER;IV (INFUSION)207092-002Sep 29, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Gland Pharma Ltd
CASPOFUNGIN ACETATE
caspofungin acetate
POWDER;IV (INFUSION)207092-001Sep 29, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Merck
CANCIDAS
caspofungin acetate
POWDER;IV (INFUSION)021227-002Jan 26, 2001APRXYesYes► Subscribe► SubscribeY► Subscribe
Mylan Labs Ltd
CASPOFUNGIN ACETATE
caspofungin acetate
POWDER;IV (INFUSION)207650-002Sep 29, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
CASPOFUNGIN ACETATE
caspofungin acetate
POWDER;IV (INFUSION)206110-002Dec 30, 2016APRXNoNo► Subscribe► SubscribeY ► Subscribe
Merck
CANCIDAS
caspofungin acetate
POWDER;IV (INFUSION)021227-001Jan 26, 2001APRXYesYes► Subscribe► SubscribeY► Subscribe
Merck
CANCIDAS
caspofungin acetate
POWDER;IV (INFUSION)021227-001Jan 26, 2001APRXYesYes► Subscribe► SubscribeY► Subscribe
Fresenius Kabi Usa
CASPOFUNGIN ACETATE
caspofungin acetate
POWDER;IV (INFUSION)206110-001Dec 30, 2016APRXNoNo► Subscribe► SubscribeY ► Subscribe
Mylan Labs Ltd
CASPOFUNGIN ACETATE
caspofungin acetate
POWDER;IV (INFUSION)207650-001Sep 29, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Merck
CANCIDAS
caspofungin acetate
POWDER;IV (INFUSION)021227-002Jan 26, 2001APRXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: caspofungin acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
CANCIDAS
caspofungin acetate
POWDER;IV (INFUSION)021227-002Jan 26, 2001► Subscribe► Subscribe
Merck
CANCIDAS
caspofungin acetate
POWDER;IV (INFUSION)021227-002Jan 26, 2001► Subscribe► Subscribe
Merck
CANCIDAS
caspofungin acetate
POWDER;IV (INFUSION)021227-001Jan 26, 2001► Subscribe► Subscribe
Merck
CANCIDAS
caspofungin acetate
POWDER;IV (INFUSION)021227-001Jan 26, 2001► Subscribe► Subscribe
Merck
CANCIDAS
caspofungin acetate
POWDER;IV (INFUSION)021227-001Jan 26, 2001► Subscribe► Subscribe
Merck
CANCIDAS
caspofungin acetate
POWDER;IV (INFUSION)021227-002Jan 26, 2001► Subscribe► Subscribe
Merck
CANCIDAS
caspofungin acetate
POWDER;IV (INFUSION)021227-001Jan 26, 2001► Subscribe► Subscribe
Merck
CANCIDAS
caspofungin acetate
POWDER;IV (INFUSION)021227-002Jan 26, 2001► Subscribe► Subscribe
Merck
CANCIDAS
caspofungin acetate
POWDER;IV (INFUSION)021227-001Jan 26, 2001► Subscribe► Subscribe
Merck
CANCIDAS
caspofungin acetate
POWDER;IV (INFUSION)021227-002Jan 26, 2001► Subscribe► Subscribe
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International Patent Family for Ingredient: caspofungin acetate

Country Document Number Estimated Expiration
European Patent Office2922530► Subscribe
Peru63998► Subscribe
World Intellectual Property Organization (WIPO)2014081443► Subscribe
Cyprus2374► Subscribe
Spain2607646► Subscribe
Czech Republic9803347► Subscribe
Australia706250► Subscribe
Poland329442► Subscribe
Colombia4940486► Subscribe
Yugoslavia45098► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: CASPOFUNGIN ACETATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00076Netherlands► SubscribePRODUCT NAME: CASPOFUNGINE, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT, IN HET BIJZONDER CASPOFUNGINE ACETAAT; REGISTRATION NO/DATE: EU/1/01/196/001-003 20011024
/2001Austria► SubscribePRODUCT NAME: CASPOFUNGIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE CASPOFUNGINACETAT; REGISTRATION NO/DATE: EU/01/196/001-003 20011024
C/GB02/002United Kingdom► SubscribeA 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.
01/029Ireland► SubscribePRODUCT 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
C0054France► SubscribePRODUCT NAME: CASPOFUNGIN ACETATE; REGISTRATION NO/DATE: EU/1/01/196/001 20011024
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Covington
Cipla
US Army
Johnson and Johnson
Queensland Health
Julphar
Colorcon
UBS

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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