GADOTERATE MEGLUMINE - Generic Drug Details

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

Gadoterate meglumine is the generic ingredient in three branded drugs marketed by Ge Healthcare, Guerbet, Hainan Poly, and Hengrui Pharma, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for GADOTERATE MEGLUMINE

US Patents:	0
Tradenames:	3
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	4
Clinical Trials:	15
What excipients (inactive ingredients) are in GADOTERATE MEGLUMINE?	GADOTERATE MEGLUMINE excipients list
DailyMed Link:	GADOTERATE MEGLUMINE at DailyMed

Recent Clinical Trials for GADOTERATE MEGLUMINE

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

Sponsor	Phase
Bayer	Phase 3
Boehringer Ingelheim	Phase 2
Massachusetts General Hospital	Phase 2

See all GADOTERATE MEGLUMINE clinical trials

Pharmacology for GADOTERATE MEGLUMINE

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

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
Hengrui Pharma	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	215304-005	Apr 15, 2022	AP	RX	No	No
Guerbet	DOTAREM	gadoterate meglumine	SOLUTION;INTRAVENOUS	204781-002	Mar 20, 2013	AP	RX	Yes	Yes
Hengrui Pharma	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	215304-002	Apr 11, 2022	AP	RX	No	No
Ge Healthcare	CLARISCAN	gadoterate meglumine	SOLUTION;INTRAVENOUS	210016-002	Nov 1, 2019	AP	RX	No	No
Guerbet	DOTAREM	gadoterate meglumine	SOLUTION;INTRAVENOUS	204781-004	Mar 20, 2013	AP	RX	Yes	Yes
Hainan Poly	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	218073-004	Jun 17, 2024	AP	RX	No	No