Gadobenate dimeglumine - Generic Drug Details

What are the generic drug sources for gadobenate dimeglumine and what is the scope of freedom to operate?

Gadobenate dimeglumine is the generic ingredient in two branded drugs marketed by Bracco and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for gadobenate dimeglumine

US Patents:	0
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	17
What excipients (inactive ingredients) are in gadobenate dimeglumine?	gadobenate dimeglumine excipients list
DailyMed Link:	gadobenate dimeglumine at DailyMed

Recent Clinical Trials for gadobenate dimeglumine

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

Sponsor	Phase
Bracco Imaging S.p.A.	PHASE3
University of California, San Diego	PHASE3
National Cancer Institute (NCI)	Phase 4

See all gadobenate dimeglumine clinical trials

Pharmacology for gadobenate dimeglumine

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

US Patents and Regulatory Information for gadobenate dimeglumine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-001	Nov 23, 2004		RX	Yes	Yes
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-004	Nov 23, 2004		RX	Yes	Yes
Bracco	MULTIHANCE MULTIPACK	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021358-002	Nov 23, 2004		RX	Yes	Yes

Expired US Patents for gadobenate dimeglumine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-001	Nov 23, 2004	4,916,246
Bracco	MULTIHANCE MULTIPACK	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021358-002	Nov 23, 2004	4,916,246
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-002	Nov 23, 2004	4,916,246

Market Dynamics and Financial Trajectory for Gadobenate Dimeglumine

Last updated: February 16, 2026

Gadobenate dimeglumine, marketed as MultiHance by Bracco Imaging, is a gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI). It enhances imaging of the CNS, liver, and other tissues. Its market depends heavily on regulatory shifts, competitive landscape, clinical guidelines, and technological advances in MRI diagnostics.

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Regulatory Status and Approvals

Gadobenate dimeglumine received FDA approval in 2004 and EMA approval shortly thereafter. U.S. prescriptions are governed by the FDA, while the European market follows EMA regulations. Regulatory updates, such as restrictions on GBCAs due to concerns over gadolinium retention, impact market presence.

In 2017, the FDA issued warnings on gadolinium retention in the brain, leading to increased scrutiny over GBCAs. These concerns prompted shifts in clinical guidelines, favoring agents with better safety profiles or alternative imaging methods.

Market Size and Growth Drivers

Global Market Valuation

• The global MRI contrast agent market was valued at approximately $2.2 billion in 2022.
• Gadobenate dimeglumine held roughly 10-15% of this market, valued at about $220-$330 million.

Growth Drivers

• Rising prevalence of neurological and liver conditions (e.g., multiple sclerosis, liver cirrhosis).
• Technological advancements in MRI imaging increasing demand for high-contrast agents.
• Expanding indications in oncology and cardiology imaging.
• Recent concerns over gadolinium retention have led clinicians to favor agents perceived as safer, sometimes affecting overall contrast agent sales.

Competitive Landscape

Major competing agents include:

• Gadopentetate dimeglumine (Magnevist)
• Gadobutrol (Gadavist)
• Gadoterate meglumine (Dotarel)
• Gadoxetate disodium (Eovist)

Gadobenate's unique property is its moderate protein binding (approximately 0.5%), which enhances the relaxivity and improves image quality at lower doses compared to some competitors.

However, emerging agents with higher relaxivity, such as gadobutrol, and the push for safer, macrocyclic GBCAs influence market share dynamics.

Pricing and Reimbursement

Pricing varies across regions. In the U.S., a standard dose (0.1 mmol/kg) costs approximately $100-$200, depending on healthcare providers and negotiated contracts. Insurance reimbursement policies, including Medicare, influence market penetration.

Reimbursement policies are evolving, especially with FDA advisories and EMA restrictions that prompt hospitals to reassess contrast agent use, potentially reducing overall sales.

Market Challenges and Opportunities

Challenges

• Gadolinium retention concerns suppress demand in some applications.
• Regulatory restrictions limit use in certain demographics.
• Competition from macrocyclic agents offering lower retention risk.

Opportunities

• Use in specialized imaging where high relaxivity enhances diagnostic accuracy.
• Development of formulations with reduced retention profiles.
• Expansion into emerging markets due to increased MRI adoption.

Financial Trajectory and Future Outlook

The revenue for gadobenate dimeglumine is expected to decline modestly over the next five years, correlating with overall contrast agent market trends, unless new indications, formulations, or markets emerge.

• Estimated Revenue in 2027: $150-$200 million, representing a 10-20% decrease from 2022 levels.
• Factors Supporting Steady Revenue: Clinical adoption in liver and neuroimaging, infrastructure investments in MRI technology, and ongoing research confirming its safety profile in certain indications.

Investment in R&D for safer, high-relaxivity GBCAs could influence future revenue streams, especially if regulatory changes favor agents with lower gadolinium retention profiles.

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Summary of Key Market Data

Aspect	Details
Market size (2022)	~$2.2 billion (global MRI contrast agents)
Gadobenate dimeglumine's share	10–15%, estimated ~$220–330 million
Pricing (US)	$100–$200 per dose
Regulatory impact	FDA/EMA restrictions affecting use
Competition	Gadopentetate dimeglumine, gadobutrol, gadoterate
Growth projection (2022–2027)	10–20% decline in revenue

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Key Takeaways

• Gadobenate dimeglumine remains a significant contrast agent for MRI, but its market share faces pressure from safety concerns and competition.
• Regulatory restrictions stemming from gadolinium retention fears impose constraints but also stimulate R&D for safer alternatives.
• Revenue is expected to decline slowly, barring innovation or market expansion.
• Technological advances and clinical demand sustain utilization in specific indications, underpinning its ongoing market relevance.

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FAQs

1. How does gadobenate dimeglumine compare to other GBCAs in safety?
It has moderate protein binding and a lower reported risk of gadolinium retention than linear agents, but macrocyclic agents are generally considered safer regarding retention.

2. What regions are primary markets for gadobenate dimeglumine?
The U.S., Europe, and Asia-Pacific are key markets, with growth driven by increasing MRI use and expanding healthcare infrastructure.

3. What are the main clinical indications for gadobenate dimeglumine?
Neuroimaging for brain and spinal cord, liver imaging to evaluate hepatocellular carcinoma, and certain oncological assessments.

4. How might regulatory changes impact future sales?
Restrictions on linear GBCAs and preferences for macrocyclic agents could reduce demand unless gadobenate is reformulated or repositioned with a safer profile.

5. Are there ongoing R&D efforts related to gadobenate dimeglumine?
Yes. Efforts focus on reducing gadolinium retention, improving relaxivity, and expanding indications, which may influence future market dynamics.

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Sources

[1] MarketWatch, "Global MRI Contrast Agents Market," 2022.
[2] FDA, Safety Communications on Gadolinium Retention, 2017.
[3] Bracco Imaging, MultiHance product info, 2023.
[4] ResearchAndMarkets, "MRI Contrast Agents Market Report," 2022.