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Details for Generic Name: gadoteridol

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Gadoteridol is the generic ingredient in two branded drugs marketed by Bracco and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has ten patent family members in five countries.

One supplier is listed for this compound.

Summary for Generic Name: gadoteridol

Tradenames:2
Patents:1
Applicants:1
NDAs:2
Drug Master File Entries: 0
Suppliers: see list1
Formulation / Manufacturing:see details

Pharmacology for Ingredient: gadoteridol

Clinical Trials for: gadoteridol

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bracco
PROHANCE MULTIPACK
gadoteridol
INJECTABLE;INJECTION021489-001Oct 9, 2003RXYes5,846,519<disabled><disabled>
Bracco
PROHANCE
gadoteridol
INJECTABLE;INJECTION020131-001Nov 16, 1992RXYes5,846,519<disabled><disabled>
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Non-Orange Book Patents for Generic Ingredient: gadoteridol

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,674,470 Method for imaging mammalian tissue using 1-substituted- 4,7,10-tricarboxymethyl-1,4,7,10-tetraazacyclododecane and analogs<disabled in preview>
4,885,363 1-substituted-1,4,7-triscarboxymethyl-1,4,7,10-tetraazacyclododecane and analogs<disabled in preview>
6,143,274 Method for imaging and radiopharmaceutical therapy using 1-substituted-4,7,10-tricarboxymethyl-1,4,7,10-tetraazacyclododecane and analogs<disabled in preview>
5,474,756 Method for imaging mammalian tissue using 1-substituted-1,4,7-tricarboxymethyl-1,4,7,10-tetraazacyclododecane and analogs<disabled in preview>
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International Patent Family for Ingredient: gadoteridol

Country Document Number Publication Date
European Patent Office0292689Nov 30, 1988
Germany3855451Sep 05, 1996
Canada1296715Mar 03, 1992
European Patent Office0232751Sep 11, 1991
Mexico174467May 17, 1994
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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