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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Citi
Chinese Patent Office
Mallinckrodt
Express Scripts
Farmers Insurance
Moodys
Boehringer Ingelheim
Accenture

Generated: June 18, 2018

DrugPatentWatch Database Preview

Gadobutrol - Generic Drug Details

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What are the generic drug sources for gadobutrol and what is the scope of gadobutrol freedom to operate?

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.

Gadobutrol has twenty-five patent family members in sixteen countries.

There is one drug master file entry for gadobutrol. One supplier is listed for this compound.
Summary for gadobutrol
International Patents:25
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Suppliers / Packagers: 1
Bulk Api Vendors: 20
Clinical Trials: 25
Formulation / Manufacturing:see details
DailyMed Link:gadobutrol at DailyMed
Pharmacology for gadobutrol
Synonyms for gadobutrol
(10-((1SR,2RS)-2,3-Dihydroxy-1-(hydroxymethyl)propyl)-1,4,7,10-tetraazacyclodecane-1,4,7-triacetato(3-))gadolinium
[1,4,7-Tris(carboxymethyl)-10-(1-(hydroxymethyl)-2,3-dihydroxypropyl)-1,4,7,10-tetraazacyclododecanato] gadolinium(III)
10-((1RS,2SR)-2,3-Dihydroxy-1-(hydroxymethyl)propyl)-1,4,7,10-tetraazacyclododecane-1,4,7-triacetato(3-))gadolinium
138071-82-6
2-[4,10-bis(2-oxido-2-oxoethyl)-7-[(2R,3S)-1,3,4-trihydroxybutan-2-yl]-1,4,7,10-tetrazacyclododec-1-yl]acetate; gadolinium(3+)
770691-21-9
AC1L2HBP
AC1O0V4Y
CHEBI:68841
CS-2214
D07420
D0P1IZ
DB06703
Gadavist
Gadavist (TN)
Gadobutorol
Gadobutrol (JAN/USAN/INN)
Gadobutrol [USAN:INN:JAN]
gadobutrolum
Gadograf
Gadolinium-DO3A-butriol
Gadolinium, (10-(2,3-Dihydroxy-1-(hydroxymethyl)propyl)-1,4,7,10-tetraazacyclodecane-1,4,7-triacetato(3-)-N1,N4,N7,N10,O1,O4,O7)-
Gadolinium, (10-(2,3-Dihydroxy-1-(hydroxymethyl)propyl)-1,4,7,10-tetraazacyclododecane-1,4,7-triacetato(3-)-N1,N4,N7,N10,O1,O4,O7)-
gadolinium(3+) 2-[4,7-bis(carboxylatomethyl)-10-(1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecan-1-yl]acetate
gadolinium(III) 2,2',2''-(10-((2R,3S )-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,4,7-triyl)triacetate
Gadovist
gallium 2-[4,10-bis(2-oxido-2-oxoethyl)-7-[(2R,3S)-1,3,4-trihydroxybutan-2-yl]-1,4,7,10-tetrazacyclododec-1-yl]acetate
Gd-BT-DO3A
Gd-DO3A-butriol
Gd-DO3A-butrol
Gd3+-10-(2,3-dihydroxy-1-hydroxymethylpropyl)-1,4,7,10-tetraazacyclododecane-1,4,7-triacetic acid
HY-16217
Protovist
rac-[2,2',2''-{10-[(2S,3R)-1,3,4-trihydroxybutan-2-yl]-1,4,7,10-tetraazacyclododecane-1,4,7-triyl-kappa(4)N(1),N(4),N(7),N(10)}triacetato(3-)]gadolinium
SCHEMBL1651120
UNII-1BJ477IO2L component ZPDFIIGFYAHNSK-CTHHTMFSSA-K
ZK 135079
ZPDFIIGFYAHNSK-UHFFFAOYSA-K

US Patents and Regulatory Information for gadobutrol

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 201277-002 Mar 14, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-006 Dec 18, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-005 Mar 14, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-004 Mar 14, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 gadobutrol

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

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Non-Orange Book US Patents for 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
6,399,043 1,4,7,10-Tetraazacyclododecane butyltriols, processes for their production and pharmaceutical agents containing them ➤ Try a Free Trial
6,951,639 1,4,7,10-tetraazacyclododecane butyltriols, processes for their production and pharmaceutical agents containing them ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for gadobutrol

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2001 00009 Denmark ➤ Try a Free Trial
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health
Daiichi Sankyo
Medtronic
Colorcon
Moodys
Deloitte
AstraZeneca
Julphar

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.