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Last Updated: June 13, 2021

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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 patent protection?

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
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 40
Clinical Trials: 37
Patent Applications: 1,133
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in gadobutrol?gadobutrol excipients list
DailyMed Link:gadobutrol at DailyMed
Recent Clinical Trials for gadobutrol

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Bayer AG (Sponsor)Phase 4
IQVIA (Sponsor)Phase 4
Bracco (Sponsor)Phase 4

See all gadobutrol clinical trials

Pharmacology for gadobutrol

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

Expired US Patents for gadobutrol

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

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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 verification 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.