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DOTAREM Drug Profile

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Which patents cover Dotarem, and what generic alternatives are available?

Dotarem is a drug marketed by Guerbet and is included in one NDA.

The generic ingredient in DOTAREM is gadoterate meglumine. One supplier is listed for this compound. Additional details are available on the gadoterate meglumine profile page.

Summary for DOTAREM

US Patents:	0
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	23
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DOTAREM
DailyMed Link:	DOTAREM at DailyMed

Generic Entry Opportunity Date for DOTAREM

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

NDA:

204781

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for DOTAREM

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

US Patents and Regulatory Information for DOTAREM

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
Guerbet	DOTAREM	gadoterate meglumine	SOLUTION;INTRAVENOUS	204781-004	Mar 20, 2013		RX	Yes	Yes
Guerbet	DOTAREM	gadoterate meglumine	SOLUTION;INTRAVENOUS	204781-002	Mar 20, 2013		RX	Yes	Yes
Guerbet	DOTAREM	gadoterate meglumine	SOLUTION;INTRAVENOUS	204781-004	Mar 20, 2013		RX	Yes	Yes
Guerbet	DOTAREM	gadoterate meglumine	SOLUTION;INTRAVENOUS	204781-005	Mar 31, 2017		RX	Yes	Yes