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CRESEMBA Drug Profile

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Which patents cover Cresemba, and what substitute generic drugs are available?

Cresemba is a drug marketed by Astellas and is included in two NDAs. There are two patents protecting this drug.

This drug has twenty-one patent family members in nineteen countries.

The generic ingredient in CRESEMBA is isavuconazonium sulfate. One supplier is listed for this compound. Additional details are available on the isavuconazonium sulfate profile page.

Summary for Tradename: CRESEMBA

Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: see list1
Bulk Api Vendors: see list2
Drug Prices:see details
DailyMed Link:CRESEMBA at DailyMed

Pharmacology for Tradename: CRESEMBA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas
CRESEMBA
isavuconazonium sulfate
CAPSULE;ORAL207500-001Mar 6, 2015RXYesYes7,459,561► SubscribeY ► Subscribe
Astellas
CRESEMBA
isavuconazonium sulfate
POWDER;IV (INFUSION)207501-001Mar 6, 2015RXYesYes7,459,561► SubscribeY ► Subscribe
Astellas
CRESEMBA
isavuconazonium sulfate
CAPSULE;ORAL207500-001Mar 6, 2015RXYesYes► Subscribe► Subscribe
Astellas
CRESEMBA
isavuconazonium sulfate
POWDER;IV (INFUSION)207501-001Mar 6, 2015RXYesYes► Subscribe► Subscribe
Astellas
CRESEMBA
isavuconazonium sulfate
POWDER;IV (INFUSION)207501-001Mar 6, 2015RXYesYes6,812,238► SubscribeY ► Subscribe
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Non-Orange Book Patents for Tradename: CRESEMBA

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
7,151,182Intermediates for N-substituted carbamoyloxyalkyl-azolium derivatives► Subscribe
7,189,858N-phenyl substituted carbamoyloxyalkyl-azolium derivatives► Subscribe
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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: CRESEMBA

Country Document Number Estimated Expiration
Canada2680292► Subscribe
Japan2003513090► Subscribe
Brazil0015254► Subscribe
Denmark1280795► Subscribe
Japan3787307► 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: CRESEMBA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90011-0Sweden► SubscribePRODUCT NAME: ISAVUCONAZOLE; REG. NO/DATE: EU/1/15/1036 20151016
C0096France► SubscribePRODUCT NAME: ISAVUCONAZOLE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
939Luxembourg► SubscribePRODUCT NAME: ISAVUCONBAZOLE EN TANT QUE SULFATE D'ISAVUCONAZONIUM OU EN TANT QUE SEL D'ISAVUCONAZONIUM AVEC TOUT AUTRE ANION PHARMACEUTIQUEMENT ACCEPTABLE, OPTIONNELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE; FIRST REGISTRATION: 20151019
0791Netherlands► SubscribePRODUCT NAME: ISAVUCONAZOL ALS ISAVUCONAZONIUM SULFAAT OF ALS EEN ISAVUCONAZONIUM ZOUT MET ELK ANDER FARMACEUTISCH AANVAARDBAAR ANION, NAAR KEUZE IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/15/1036 20151019
2016 00002Denmark► SubscribePRODUCT NAME: ISAVUCONAZOLE AS ISAVUCONAZONIUM SULFATE OR AS AN ISAVUCONAZONIUM SALT WITH ANY OTHER PHARMACEUTICALLY ACCEPTABLE ANION, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, OR SOLVATE; REG. NO/DATE: EU/1/15/1036 20151019
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