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Generated: September 19, 2018

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GADAVIST Drug Profile

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When do Gadavist patents expire, and when can generic versions of Gadavist launch?

Gadavist is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in GADAVIST is gadobutrol. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gadobutrol profile page.

Drug patent expirations by year for GADAVIST
Generic Entry Opportunity Date for GADAVIST
Generic Entry Date for GADAVIST*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for GADAVIST

US Patents and Regulatory Information for GADAVIST

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-006 Dec 18, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-003 Mar 14, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-001 Mar 14, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-002 Mar 14, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-005 Mar 14, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-004 Mar 14, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for GADAVIST

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-001 Mar 14, 2011 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-005 Mar 14, 2011 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-004 Mar 14, 2011 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-003 Mar 14, 2011 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-002 Mar 14, 2011 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for GADAVIST

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
6,399,043 1,4,7,10-Tetraazacyclododecane butyltriols, processes for their production and pharmaceutical agents containing them ➤ Sign Up
6,951,639 1,4,7,10-tetraazacyclododecane butyltriols, processes for their production and pharmaceutical agents containing them ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for GADAVIST

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2001 00009 Denmark ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Farmers Insurance
Healthtrust
Cantor Fitzgerald
Cerilliant
UBS
Accenture
Moodys
Cipla

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