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Isavuconazonium sulfate - Generic Drug Details

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Isavuconazonium sulfate is the generic ingredient in one branded drug marketed by Astellas and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty patent family members in eighteen countries.

One supplier is listed for this compound.

Summary for Generic Name: isavuconazonium sulfate

Tradenames:1
Patents:2
Applicants:1
NDAs:2
Drug Master File Entries: 0
Suppliers / Packaging: see list1
Drug Prices:see low prices

Pharmacology for Ingredient: isavuconazonium sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas
CRESEMBA
isavuconazonium sulfate
POWDER;IV (INFUSION)207501-001Mar 6, 2015RXYes6,812,238► subscribeY ► subscribe
Astellas
CRESEMBA
isavuconazonium sulfate
POWDER;IV (INFUSION)207501-001Mar 6, 2015RXYes► subscribe► subscribe
Astellas
CRESEMBA
isavuconazonium sulfate
CAPSULE;ORAL207500-001Mar 6, 2015RXYes► subscribe► subscribe
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Non-Orange Book Patents for Generic Ingredient: isavuconazonium sulfate

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
7,189,858N-phenyl substituted carbamoyloxyalkyl-azolium derivatives► subscribe
7,151,182Intermediates for N-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 Ingredient: isavuconazonium sulfate

Country Document Number Estimated Expiration
Japan3787307► subscribe
Austria291575► subscribe
Australia777859► 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: ISAVUCONAZONIUM SULFATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
C0096France► subscribePRODUCT NAME: ISAVUCONAZOLE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
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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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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