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Last Updated: July 28, 2021

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Gadoxetate disodium - Generic Drug Details

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What are the generic drug sources for gadoxetate disodium and what is the scope of patent protection?

Gadoxetate disodium 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.

Gadoxetate disodium has thirty-three patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for gadoxetate disodium
International Patents:33
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 19
Clinical Trials: 7
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in gadoxetate disodium?gadoxetate disodium excipients list
DailyMed Link:gadoxetate disodium at DailyMed
Recent Clinical Trials for gadoxetate disodium

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

SponsorPhase
IQVIA (Sponsor)Phase 4
Bracco (Sponsor)Phase 4
GuerbetPhase 4

See all gadoxetate disodium clinical trials

Pharmacology for gadoxetate disodium

US Patents and Regulatory Information for gadoxetate disodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare EOVIST gadoxetate disodium SOLUTION;INTRAVENOUS 022090-001 Jul 3, 2008 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Bayer Hlthcare EOVIST gadoxetate disodium SOLUTION;INTRAVENOUS 022090-002 Feb 4, 2013 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for gadoxetate disodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0405704 16/2005 Austria ⤷  Free Forever Trial PRODUCT NAME: GADOXETSAEURE DINATRIUM; NAT. REGISTRATION NO/DATE: 1-25757, 1-25758 20050302; FIRST REGISTRATION: SE 18929, 18930 20040326
0405704 300182 Netherlands ⤷  Free Forever Trial 300182, 20100627, EXPIRES: 20150626
0405704 C00405704/01 Switzerland ⤷  Free Forever Trial FORMER OWNER: BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, DE
0405704 C300182 Netherlands ⤷  Free Forever Trial PRODUCT: GADOXETINEZUUR, DESGEWENST IN DE VORM VAN EEN ZOUT, IN HET BIJZONDER HET NATRIUMZOUT. FIRST AUTHORIZATION NO/DATE: 1829 AND 18930, 20040326 (SE); NATIONAL AUTHORIZATION NO/DATE: RVG 31393 AND 31394, 20050113
0405704 SPC/GB05/021 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: GADOXETIC ACID, OPTIONALLY IN THE FORM OF A SALT; REGISTERED: SE 18929 20040326; SE 18930 20040326; UK PL 00053/0348 20041110; UK PL 00053/0349 20041110
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Medtronic
McKinsey
AstraZeneca
Baxter
Johnson and Johnson

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