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Gadobutrol - Generic Drug Details

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Gadobutrol is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-four patent family members in sixteen countries.

There is one drug master file entry for gadobutrol. One supplier is listed for this compound.

Summary for Generic Name: gadobutrol

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: see list1
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details

Pharmacology for Ingredient: gadobutrol

Clinical Trials for: gadobutrol

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
GADAVIST
gadobutrol
SOLUTION;INTRAVENOUS201277-004Mar 14, 2011RXYes<disabled><disabled>
Bayer Hlthcare
GADAVIST
gadobutrol
SOLUTION;INTRAVENOUS201277-006Dec 18, 2013RXYes<disabled><disabled>
Bayer Hlthcare
GADAVIST
gadobutrol
SOLUTION;INTRAVENOUS201277-002Mar 14, 2011RXYes5,980,864<disabled>YY <disabled>
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Non-Orange Book Patents for Generic Ingredient: gadobutrol

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
6,951,639 1,4,7,10-tetraazacyclododecane butyltriols, processes for their production and pharmaceutical agents containing them<disabled in preview>
6,399,043 1,4,7,10-Tetraazacyclododecane butyltriols, processes for their production and pharmaceutical agents containing them<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 Ingredient: gadobutrol

Country Document Number Estimated Expiration
Hong Kong1002811<disabled in preview>
Australia647091<disabled in preview>
Germany4009119<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: GADOBUTROL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2001 00009Denmark<disabled>
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