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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

Drug Class	Gadolinium-based Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity

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
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-006	Dec 18, 2013		RX	Yes	Yes			Y	Y
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-005	Mar 14, 2011		RX	Yes	Yes
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-004	Mar 14, 2011		RX	Yes	Yes

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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
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-001	Mar 14, 2011
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-005	Mar 14, 2011
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-003	Mar 14, 2011

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
6,951,639	1,4,7,10-tetraazacyclododecane butyltriols, processes for their production and pharmaceutical agents containing them

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International Patents for gadobutrol

Country	Document Number	Estimated Expiration
Japan	H05320146
Hungary	910874
Portugal	97065
Spain	2074219

Supplementary Protection Certificates for gadobutrol

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2001 00009	Denmark