MULTIHANCE Drug Patent Profile

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

Multihance is a drug marketed by Bracco and is included in two NDAs.

The generic ingredient in MULTIHANCE is gadobenate dimeglumine. One supplier is listed for this compound. Additional details are available on the gadobenate dimeglumine profile page.

Summary for MULTIHANCE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Patent Applications:	775
Drug Prices:	Drug price information for MULTIHANCE
What excipients (inactive ingredients) are in MULTIHANCE?	MULTIHANCE excipients list
DailyMed Link:	MULTIHANCE at DailyMed

See drug prices for MULTIHANCE

Pharmacology for MULTIHANCE

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

US Patents and Regulatory Information for MULTIHANCE

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	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-002	Nov 23, 2004		RX	Yes	Yes

Expired US Patents for MULTIHANCE

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	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-004	Nov 23, 2004	4,916,246
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-003	Nov 23, 2004	4,916,246

International Patents for MULTIHANCE

See the table below for patents covering MULTIHANCE around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	6753987
Hong Kong	95793	PARAMAGNETIC CHELATES
Japan	H0364504

Supplementary Protection Certificates for MULTIHANCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0230893	99C0013	Belgium		PRODUCT NAME: GADOBENAATDIMEGLUMINE; NAT. REGISTRATION NO/DATE: 3503 IE 48 F 12 19990201; FIRST REGISTRATION: GB PL 06099/0006 19970722
0230893	C980024	Netherlands		PRODUCT NAME: GADOBEENZUUR,DESGEWENST IN DE VORM VAN EEN ZOUT MET EEN ALKA- LIMETAAL, AARDALKALIMETAAL, OF BASISCH GEPROTONEERD AMINOZUUR OF VAN EEN ALKYLAMMONIUM-, ALKANOLAMMONIUM- OF POLYHYDROXYAL- KYLAMMONIUMZOUT, IN HET BIJZONDER DIMEGLUMINI GADOBENAS; NAT. REGISTRATION NO/DATE: RVG 22324 19980706; FIRST REGISTRATION: GB PL 06099/0006 19970722
0230893	SPC/GB97/081	United Kingdom		PRODUCT NAME: GADOBENATE DIMEGLUMINE; REGISTERED: UK 06099/0006 19970722

Market Dynamics and Financial Trajectory for MULTIHANCE

Last updated: July 30, 2025

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Introduction

MULTIHANCE (gadoversetamide) Operations: Overview

MULTIHANCE, a gadolinium-based contrast agent (GBCA), is primarily used for magnetic resonance imaging (MRI) to enhance imaging quality in various clinical scenarios such as central nervous system (CNS) lesions and vascular abnormalities. Developed and marketed by Bracco Imaging, MULTIHANCE operates within a competitive landscape characterized by technological advances, regulatory scrutiny, and evolving clinical guidelines.

This document comprehensively analyzes the market forces shaping MULTIHANCE's economic prospects, explores key drivers and constraints, and projects its financial trajectory over the coming years for healthcare industry stakeholders.

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Market Landscape and Competitive Environment

Global MRI Contrast Agent Market

The MRI contrast agents market was valued at approximately USD 2.8 billion in 2022 and is projected to reach nearly USD 4 billion by 2030, registering a compound annual growth rate (CAGR) of around 5.2% (1). The segment comprises gadolinium-based agents, macrocyclic agents (like MULTIHANCE), and linear agents. The increasing prevalence of chronic diseases, broader adoption of MRI diagnostics, and technological innovations underpin market growth.

Positioning of MULTIHANCE

As a macrocyclic agent, MULTIHANCE benefits from a higher stability profile and a lower risk of gadolinium retention compared to linear counterparts, aligning well with safety-conscious clinical practices. Its niche positioning in neuroimaging grants it priority in specific markets, especially where enhanced image clarity is crucial.

Competitive Dynamics

The marketplace features several key players including Bayer's Dotarem, GE Healthcare's Omniscan, and Guerbet's Primovist. Generic entrants and emerging formulations challenge the market share of established products. Recent regulatory restrictions on linear GBCAs, driven by safety concerns over gadolinium retention, favor macrocyclic agents like MULTIHANCE, potentially bolstering its market position.

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Regulatory Environment and Clinical Guidelines Impact

Regulatory Developments

In 2017, the FDA recommended against initiating new patients on linear GBCAs and emphasized the cautious use of existing linear agents due to gadolinium retention concerns (2). The European Medicines Agency (EMA) also restricted certain linear agents, emphasizing macrocyclic contrast agents’ superior safety profiles.

This regulatory landscape favors macrocyclic agents like MULTIHANCE, fostering increased adoption where safety is prioritized. Nevertheless, in regions with less regulatory stringency, linear agents retain a foothold, constraining the market expansion potential.

Clinical Practice Trends

Contemporary guidelines increasingly recommend macrocyclic GBCAs for high-risk patients. The American College of Radiology (ACR) updated its guidelines to reflect these safety preferences. As clinicians favor safer options, demand for MULTIHANCE benefits, provided its efficacy and safety profile align with evolving standards.

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Market Drivers and Restraints

Key Drivers

• Aging Population and Disease Prevalence: The rising incidence of neurodegenerative disorders (Alzheimer’s, Parkinson’s) and cerebrovascular diseases underpins increased MRI diagnostics, favoring contrast agents.
• Technological Advancements: Higher-resolution MRI systems and enhanced imaging techniques expand the scope of contrast-enhanced imaging.
• Safety Profile of Macrocyclic Agents: The favorable safety and stability profile of MULTIHANCE in comparison to linear agents increases its clinical appeal.
• Regulatory restrictions on linear GBCAs: These regulations prompt institutions to favor macrocyclic options, including MULTIHANCE, accelerating its market adoption.

Key Restraints

• High Cost of Contrast Agents: Gadolinium agents are costly, and hospitals increasingly scrutinize their utilization to manage expenses.
• Environmental and Safety Concerns: Gadolinium retention and potential long-term effects restrict usage and influence physician choice.
• Competitive Pricing and Generics: Entry of lower-priced generics pressures profit margins and market share of branded products like MULTIHANCE.
• Limited Indications: MRI contrast agents are primarily used for imaging specific conditions; the niche indications limit growth potential.

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Financial Trajectory and Market Opportunities

Historical Performance

Bracco's strategic focus on macrocyclic agents has facilitated stable revenue streams for MULTIHANCE in regions emphasizing safety. The product's sales were relatively stable pre-2017 but experienced volatility aligned with regulatory shifts and competitive pressures.

Projected Growth

Based on current market trends, the demand for macrocyclic agents, including MULTIHANCE, is expected to grow at a CAGR of approximately 4–6% over the next five years (1). The primary growth catalysts include increased diagnostic imaging in aging populations and regulatory mandates favoring safer agents.

Emerging Opportunities

• Expanding into Emerging Markets: Rapid healthcare infrastructure development in Asia-Pacific and Latin America presents growth avenues.
• Product Line Expansion: Development of new formulations or combination products could diversify usage.
• Increased Adoption in Specialty Imaging: Enhanced utilization in cerebrovascular, oncologic, and neurodegenerative diagnostics.

Potential Challenges

• Pricing Pressures: Cost containment initiatives in healthcare could suppress revenue growth.
• Environmental Regulations: Growing environmental concerns regarding gadolinium disposal and retention might limit usage.
• Regulatory Approvals and Patent Expirations: Patent cliffs and regulatory pipeline issues could impact profitability.

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Future Outlook and Strategic Implications

The outlook for MULTIHANCE remains cautiously optimistic, hinging on regulatory trends favoring safety, technological advancements, and market expansion into emerging economies. Companies need to invest in lifecycle management, including health economic studies demonstrating value and safety, to sustain and grow revenues.

Bracco's strategy might include:

• Focusing on regions with lax regulations and expanding educational efforts about macrocyclic agents’ safety.
• Developing next-generation contrast agents with improved safety, efficacy, and environmental profiles.
• Collaborating with healthcare providers to optimize contrast agent usage, aligning with cost-effectiveness and patient safety.

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Key Takeaways

• The shift towards macrocyclic GBCAs due to safety concerns favors MULTIHANCE's market position.
• Market growth is driven by rising MRI use, aging populations, and regulatory support, although cost pressures limit rapid expansion.
• Competitive dynamics require continuous innovation and strategic regional expansion.
• Environmental and safety regulations pose both risks and opportunities, influencing future product development.
• Healthcare providers’ preference for safety enhances MULTIHANCE’s long-term prospects but necessitates ongoing evidence generation and compliance.

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FAQs

1. What factors are most influencing the demand for MULTIHANCE?
   Growing safety concerns over linear GBCAs, increasing MRI utilization, and regulatory shifts favor macrocyclic agents bolster demand.

2. How might regulatory trends impact MULTIHANCE’s market share in the future?
   Regulations limiting linear agents and emphasizing safety are likely to enhance MULTIHANCE’s position, provided safety and efficacy are maintained.

3. What are key challenges facing MULTIHANCE’s growth?
   Price competition, environmental concerns related to gadolinium retention, and regulatory restrictions pose significant challenges.

4. Are there emerging markets for MULTIHANCE?
   Yes, regions like Asia-Pacific and Latin America present growth opportunities due to expanding healthcare infrastructure and increasing imaging procedures.

5. What strategies should companies pursue to optimize the financial trajectory of macrocyclic contrast agents?
   Strategies include regional expansion, innovation in formulation, educational campaigns emphasizing safety, and cost-effectiveness demonstrations.

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References

1. MarketsandMarkets. “MRI Contrast Agents Market Analysis & Trends.” 2022.
2. U.S. Food and Drug Administration (FDA). “Gadolinium-Based Contrast Agents: Safety Communications.” 2017.