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Last Updated: November 21, 2019

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Gadoterate meglumine - Generic Drug Details

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What are the generic drug sources for gadoterate meglumine and what is the scope of patent protection?

Gadoterate meglumine is the generic ingredient in one branded drug marketed by Guerbet and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for gadoterate meglumine
Recent Clinical Trials for gadoterate meglumine

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

SponsorPhase
Boston Medical CenterPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloN/A
University of Campinas, BrazilN/A

See all gadoterate meglumine clinical trials

Pharmacology for gadoterate meglumine

US Patents and Regulatory Information for gadoterate meglumine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Guerbet DOTAREM gadoterate meglumine SOLUTION;INTRAVENOUS 204781-005 Mar 31, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Guerbet DOTAREM gadoterate meglumine SOLUTION;INTRAVENOUS 204781-001 Mar 20, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Guerbet DOTAREM gadoterate meglumine SOLUTION;INTRAVENOUS 204781-003 Mar 20, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Guerbet DOTAREM gadoterate meglumine SOLUTION;INTRAVENOUS 204781-004 Mar 20, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Guerbet DOTAREM gadoterate meglumine SOLUTION;INTRAVENOUS 204781-002 Mar 20, 2013 RX Yes Yes   Start Trial   Start Trial   Start 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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