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CANCIDAS Drug Profile

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Cancidas is a drug marketed by Merck and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-three patent family members in forty-seven countries.

The generic ingredient in CANCIDAS is caspofungin acetate. There are seven drug master file entries for this compound. One supplier is listed for this compound. There are two tentative approvals for this compound. Additional details are available on the caspofungin acetate profile page.

Summary for Tradename: CANCIDAS

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: CANCIDAS

Ingredient-typeLipopeptides
Drug ClassEchinocandin Antifungal

Clinical Trials for: CANCIDAS

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-001Jan 26, 2001RXYes5,514,650*PEDJul 26, 2015
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-002Jan 26, 2001RXYes5,514,650*PEDJul 26, 2015
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-001Jan 26, 2001RXYes5,952,300*PEDSep 28, 2017Y
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Expired Patents for Tradename: CANCIDAS

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-001Jan 26, 20015,378,804*PED<disabled>
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-001Jan 26, 20015,792,746*PED<disabled>
Merck
CANCIDAS
caspofungin acetate
INJECTABLE;IV (INFUSION)021227-001Jan 26, 20015,514,650*PED<disabled>
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Paragraph IV activity for: CANCIDAS

Drugname Dosage Strength RLD Submissiondate
caspofungin acetateFor Injection50 mg/vial and 70 mg/vialCancidas6/26/2009

Non-Orange Book Patents for Tradename: CANCIDAS

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,378,804 Aza cyclohexapeptide compounds<disabled in preview>
5,792,746 Aza cyclohexapeptide compounds<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: CANCIDAS

Country Document Number Estimated Expiration
Hungary9901586<disabled in preview>
Norway953648<disabled in preview>
JapanH06321986<disabled in preview>
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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: CANCIDAS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
01/029Ireland<disabled>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
C0036France<disabled>PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
C/GB02/002United Kingdom<disabled>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.
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