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Last Updated: January 26, 2020

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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 two branded drugs marketed by Ge Healthcare and Guerbet, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for gadoterate meglumine
Recent Clinical Trials for gadoterate meglumine

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

Boston Medical CenterPhase 4
University of Campinas, BrazilN/A
Fundação de Amparo à Pesquisa do Estado de São PauloN/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 204781-001 Mar 20, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Guerbet DOTAREM gadoterate meglumine SOLUTION;INTRAVENOUS 204781-004 Mar 20, 2013 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Ge Healthcare CLARISCAN gadoterate meglumine SOLUTION;INTRAVENOUS 210016-003 Nov 1, 2019 AP RX No No   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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