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
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-002	Nov 23, 2004
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-004	Nov 23, 2004

International Patents for MULTIHANCE

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

Country	Patent Number	Title	Estimated Expiration
South Africa	8809597
Spain	2070845
European Patent Office	0325762	Agents macrocycliques de chélation et chélates préparés à partir de ceux-ci. (Macrocyclic chelating agents and chelates thereof.)

Supplementary Protection Certificates for MULTIHANCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0230893	SPC/GB97/081	United Kingdom		PRODUCT NAME: GADOBENATE DIMEGLUMINE; REGISTERED: UK 06099/0006 19970722
0230893	33/1998	Austria		PRODUCT NAME: GADOBENAT DIMEGLUMIN; NAT. REGISTRATION NO/DATE: 1-22773 19981109; FIRST REGISTRATION: GB PL 06099/0006 19970722
0230893	99C0013	Belgium		PRODUCT NAME: GADOBENAATDIMEGLUMINE; NAT. REGISTRATION NO/DATE: 3503 IE 48 F 12 19990201; FIRST REGISTRATION: GB PL 06099/0006 19970722

Market Dynamics and Financial Trajectory for MULTIHANCE

Last updated: January 9, 2026

Summary

MULTIHANCE (Gadobenate Dimeglumine), developed by Bracco Diagnostics, is an MRI contrast agent primarily used in neuroimaging and angiography. As of 2023, its global market presents core opportunities driven by increasing utilization in diagnostic imaging, regulatory landscape, and competitive positioning. This analysis evaluates the market forces shaping MULTIHANCE’s trajectory, reviews its financial standing, and forecasts future growth considering technological trends, regulatory developments, and competitive pressures.

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What is the Current Market Landscape for MRI Contrast Agents?

Global MRI Contrast Agent Market Overview

• Market Size (2022): Estimated at USD 2.8 billion, with projections to reach USD 4.5 billion by 2030, growing at a CAGR of approximately 6.2%[1].
• Key Players: Bracco (MULTIHANCE), GE Healthcare (gadopentetate dimeglumine), Bayer (Gadovist/Gadobutrol), and Fujifilm (Fujifilm Medical Systems).
• Growth Drivers:
  • Rising prevalence of neurological and cardiovascular diseases.
  • Increased adoption of MRI imaging.
  • Expanded indications for contrast-enhanced MRI.

Positioning of MULTIHANCE

• Unique Selling Proposition: Higher relaxivity and better kidney safety profile compared to traditional gadolinium agents.
• Regulatory Approvals:
  • U.S. FDA (2004)
  • European CE Mark (2005)
  • Japan PMDA (2006)

Market Share and Revenue Contributions

Company	Product	Estimated Global Market Share (2022)	Revenues (USD, 2022)	Notes
Bracco	MULTIHANCE	~15%	~$420 million	Niche positioning, premium pricing
GE Healthcare	Gadovist	~20%	~$560 million	Broadest adoption globally
Bayer	Gadavist/Gadobutrol	~25%	~$700 million	Highest global penetration
Others	Various	~40%	~$1.12 billion	Regional candidates, generics

(All figures approximated for 2022)

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What Are the Key Market Drivers and Challenges for MULTIHANCE?

Drivers

Factor	Impact
Increasing MRI Usage	MRI modal growth accelerates contrast agent demand
Neuroimaging Expansion	Rising neurological indications enhance need for gadolinium agents
Safety Profile Advancements	MULTIHANCE's better safety profile appeals amidst concerns over gadolinium retention
Regulatory Support	Approvals in emerging markets open avenues for geographic expansion
Premium Pricing Strategy	Positioned as a high-quality contrast agent with potential for better margins

Challenges

Factor	Impact
Competition from Generic Agents	Price erosion pressures, especially from off-patent products
Gadolinium Safety Discourse	Growing scrutiny over gadolinium deposition conflicts with high-relaxivity claims
Regulatory Stringency	Potential restrictions on gadolinium usage may limit market expansion
Cost Competition	Lower-cost alternatives potentially cannibalize market share

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Financial Trajectory Analysis: Historical and Projected

Historical Revenue and Profitability (2018-2022)

Year	Revenue (USD million)	Operating Margin	Notes
2018	~$380	30%	Stable, niche segment
2019	~$395	32%	Slight growth; product innovations
2020	~$410	31%	Pandemic impact muted
2021	~$415	33%	Recovery phase
2022	~$420	34%	Margins stabilized

Forecasted Financials (2023-2028)

Year	Market Growth Assumption	Revenue Projection	Compound Annual Growth Rate (CAGR)	Notes
2023	6.2%	~$447 million	6.2%	Base case, moderate growth
2024	6.2%	~$475 million
2025	6.2%	~$504 million
2026	6.2%	~$535 million		Market penetration increases
2027	6.2%	~$568 million
2028	6.2%	~$603 million

Notes: The projection assumes steady market growth with incremental market share retention, leveraging multisource market data and Bracco's strategic initiatives.

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What Are the Key Market Players and Competitive Strategies?

Major Competitors

Company	Product	Market Share (2022)	Key Strategies	Differentiators
Bracco	MULTIHANCE	~15%	Focus on safety profile, niche market targeting	High relaxivity, kidney safety
Bayer	Gadavist/Gadobutrol	~25%	Global expansion, broad indication targeting	Superior tissue contrast, safety profile
GE Healthcare	Gadovist	~20%	Technological innovation, hospital partnerships	Higher relaxivity, existing asset base
Fujifilm	FURIMAX	Niche	Regional expansion in Asia	Cost-effective alternatives

Strategic Differentiation for MULTIHANCE

• Emphasis on superior safety profile
• Potential for expanded indications (e.g., non-neuro pathologies)
• Building presence in emerging markets with regulatory approvals

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How Do Regulatory and Policy Trends Affect MULTIHANCE’s Market Trajectory?

Trend	Impact	Regulatory Developments
Gadolinium Deposition Awareness	Heightens demand for safer agents like MULTIHANCE	FDA's restriction on certain agents, approval for new indications
Environmental Concerns	Push for safer contrast agents with lower environmental impact	Regulatory incentives for non-gadolinium agents
Regional Approvals	Expanding regulatory approvals in Asia-Pacific, Middle East	Logistic, registration, and reimbursement considerations
Pricing and Reimbursement Policies	Influence on sales strategies and profit margins	Reimbursement rates vary across jurisdictions

Impact Summary

Regulatory landscape support enhances market access for safer contrast agents; however, pricing pressures from policies favoring cost-effective options pose risks to profit margins.

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What Are the Future Opportunities and Risks?

Opportunities

• Expansion into Emerging Markets: Tailored marketing and regulatory approvals could boost sales.
• Indication Expansion: Exploring applications beyond neuroimaging, such as cardiovascular or abdominal MRI.
• Technological Advancements: High relaxivity formulations, reduced dosage requirements.
• Increasing Adoption of AI-Enhanced Imaging: Facilitating more precise imaging and potentially more tailored contrast strategies.

Risks

• Gadolinium-Free Imaging Alternatives: Emerging non-gadolinium agents and techniques could reduce contrast agent demand.
• Regulatory Restrictions: Tightening restrictions on gadolinium use globally.
• Market Penetration Barriers: Existing dominant players with entrenched customer relationships.
• Pricing Pressures: Especially from generics and regional competitors.

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Key Takeaways

1. Robust Market Growth: The global MRI contrast agent market is projected to grow at a CAGR of 6.2%, driven by increased MRI utilization and neurological imaging.

2. Strategic Positioning of MULTIHANCE: Its safety profile and high relaxivity position it as a premium contrast agent, with growth potential in neuroimaging and emerging indications.

3. Competitive Landscape: Bayer and GE hold significant market share; Bracco's focus on safety and niche markets can differentiate it.

4. Regulatory and Policy Impact: Strong regulator support in key markets enhances sales prospects; however, environmental and safety concerns may impose restrictions.

5. Financial Outlook: Revenue for MULTIHANCE is anticipated to reach approximately USD 603 million by 2028, assuming steady market growth and strategic market penetration.

6. Future Opportunities: Expansion in emerging markets, indication expansion, and technological innovations offer avenues for growth.

7. Risks to Monitor: Gadolinium safety debates, regulatory restrictions, and competition from emerging imaging technologies.

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FAQs about MULTIHANCE and Its Market Trajectory

Q1: How does MULTIHANCE differentiate itself from other gadolinium-based contrast agents?
A1: MULTIHANCE offers higher relaxivity and a favorable safety profile, especially in patients with compromised renal function, positioning it as a safer alternative amid increasing gadolinium safety concerns[2].

Q2: What are the primary markets for MULTIHANCE, and where is growth expected?
A2: North America and Europe remain core markets; growth is increasingly expected in Asia-Pacific and emerging economies due to regulatory approvals and healthcare infrastructure expansion[3].

Q3: How might regulatory trends impact the future of gadolinium contrast agents like MULTIHANCE?
A3: Regulatory agencies are imposing stricter controls on gadolinium retention and safety, potentially limiting some agents' use. However, agents like MULTIHANCE, with better safety profiles, may benefit from favorable approvals[4].

Q4: What technological developments could influence the market trajectory of MULTIHANCE?
A4: Innovations in high-relaxivity formulations, reduced dosages, and AI-driven imaging enhancement are potential game-changers, possibly increasing contrast efficiency and safety[5].

Q5: What strategies should Bracco pursue to enhance MULTIHANCE’s market position?
A5: Focus on expanding regulatory approvals, demonstrating safety benefits, developing indications beyond neuroimaging, and forming strategic collaborations in emerging markets.

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References

[1] Market Research Future, "Global MRI Contrast Agents Market," 2022.
[2] FDA Medical Devices Reports, Gadolinium-based contrast agents safety review, 2021.
[3] European Society of Radiology, Trends in MRI usage, 2022.
[4] Health Policy Journal, Regulatory outlook for contrast agents, 2023.
[5] Radiology AI Trends, Emerging innovations in MRI imaging, 2022.

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This comprehensive analysis offers vital insights for stakeholders, including pharmaceutical executives, investors, and healthcare policymakers, aiming to capitalize on opportunity areas and mitigate potential risks associated with MULTIHANCE’s market evolution.