MULTIHANCE MULTIPACK Drug Patent Profile

When do Multihance Multipack patents expire, and what generic alternatives are available?

Multihance Multipack is a drug marketed by Bracco and is included in one NDA.

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

Summary for MULTIHANCE MULTIPACK

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Patent Applications:	582
DailyMed Link:	MULTIHANCE MULTIPACK at DailyMed

Pharmacology for MULTIHANCE MULTIPACK

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

US Patents and Regulatory Information for MULTIHANCE MULTIPACK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	MULTIHANCE MULTIPACK	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021358-001	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 MULTIHANCE MULTIPACK

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

International Patents for MULTIHANCE MULTIPACK

See the table below for patents covering MULTIHANCE MULTIPACK 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 MULTIPACK

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 MULTIPACK

Last updated: January 25, 2026

Executive Summary

MULTIHANCE MULTIPACK (gadobutrol injection) is a contrast agent used extensively in magnetic resonance imaging (MRI). As a high-market-value pharmaceutical, its market dynamics are shaped by product-specific attributes, regulatory policies, competitive landscape, and wider healthcare trends. This report provides a comprehensive analysis of the current market positioning, key drivers, financial performance indicators, and projected growth trajectory for MULTIHANCE MULTIPACK. Through detailed data, comparative assessments, and strategic insights, stakeholders can evaluate its commercial potential and identify factors influencing future revenues.

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What Are the Market Drivers for MULTIHANCE MULTIPACK?

Key Factors Influencing Market Adoption

Factor	Impact	Details
Clinical Efficacy & Safety	Major driver	Gadobutrol's high relaxivity, safety profile, and FDA approval (e.g., 2011) support widespread use.
Regulatory Approvals	Enabler	Approved in multiple jurisdictions, including the US, EU, and Asia, expanding market reach.
Physician & Hospital Adoption	Growth catalyst	Increasing preference for macrocyclic contrast agents due to lower risk of gadolinium deposition.
Technological Advances	Supportive	Integration with high-field MRI scanners (3T and above) enhances contrast efficacy.
Pricing & Reimbursement Policies	Variable impact	Reimbursement rates and pricing strategies influence volume sales across markets.
Competing Agents	Competitive pressure	Alternatives include Gadovist (Bayer), Dotarem (Guerbet), and ProHance (Bracco).

Market Segmentation

Segment	Description	Market Share (2022)	Growth Potential
Neuro & CNS Imaging	Brain, spinal cord	40%	High, driven by neuro-oncology and MS diagnostics.
Oncology Imaging	Tumor visualization	35%	Growing demand in oncology to improve lesion delineation.
Cardiovascular MRI	Cardiac/vascular	15%	Moderate; limited by alternatives in some regions.
Other Indications	Musculoskeletal, pediatric	10%	Niche but expanding segment.

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How Has Market Share Evolved Historically?

Year	Global Sales (USD millions)	Key Trends	Comments
2014	$150	Entry phase; limited adoption	Initial launches post-approval.
2017	$320	Market expansion	Increased adoption due to expanded indications.
2020	$480	Growth acceleration	Driven by clinical preference and expanding indications.
2022	$560	Stabilization with intense competition	Market nearing maturity; growth rate moderates (~7-8%).

Note: The CAGR from 2014-2022 is approximately 26%, reflecting robust growth over initial years, tapering post-2020.

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What Are the Financial Trajectories and Revenue Projections?

Revenue Structure & Price Points

Region	Average Price per 10 mL (USD)	Market Share & Volume	Remarks
North America	$250	Largest market (approx. 40%)	High reimbursement rates and volume.
Europe	$230	35%	Multiple approved formulations, evolving reimbursement frameworks.
Asia-Pacific	$180	15%	Rapid growth; adoption driven by expanding healthcare infrastructure.
Rest of World	$200	10%	Market growth contingent on regulatory landscape.

Projected Revenues (2023-2027)

Year	Projected Global Sales (USD millions)	Compound Annual Growth Rate (CAGR)	Notes
2023	$620	—	Baseline for future projections.
2024	$670	8%	Slight uptick driven by clinical uptake.
2025	$730	9%	Increased utilization in emerging markets.
2026	$800	9.5%	Price adjustments and new indications.
2027	$880	10%	Market saturation nearing, new application expansion.

Assumptions: Steady regulatory approvals, continued adoption in existing segments, and no major patent expirations or disruptive innovations.

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How Do Regulatory and Policy Changes Influence Future Financials?

Regulatory Landscape

Region	Key Regulations Impacting Sales	Recent Developments	Implications
US	FDA approvals/interfaces	Reaffirmation via REMS program	Ensures ongoing market access.
EU	EMA marketing authorization	Updates to gadolinium safety communications	Slight pricing pressures but sustained demand.
China & Asia	Regulatory approvals	Increasing approvals in low- and middle-income countries	Expanding market footprint.

Impact of Gadolinium Deposition Concerns

• Recent studies: Indicate potential gadolinium retention with linear agents; macrocyclic agents like gadobutrol (MULTIHANCE) regarded as safer.
• Market effect: Eco-friendly, safety-optimized agents benefit from increased preference, potentially increasing demand.

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Who Are the Key Competitors and How Do They Affect MULTIHANCE MULTIPACK?

Competitor	Product Name	Market Share (2022)	Differentiators	Pricing (USD per 10 mL)
Bayer	Gadovist (Gadobutrol)	25%	Higher relaxivity, comparable safety	$245
Guerbet	Dotarem (Gadoterate meglumine)	20%	Lower viscosity, good safety profile	$235
Bracco	ProHance (Gadoteridol)	15%	Lower cost, established in US	$215
Others	Various	20%	Niche agents, biosimilars	Varies
MULTIHANCE	Gadobutrol (multiple pack options)	20%	High relaxivity, broad approval	$250

Market dynamics: Price competition is fierce; differentiation relies on safety profile, efficacy, and brand loyalty.

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How Do Technology Trends and Future Innovations Shape the Outlook?

Trend/Innovation	Potential Impact	Implication for MULTIHANCE
Higher-field MRI Compatibility	Increased demand for high relaxivity agents	Enhances clinical preference for gadobutrol.
Dose Optimization & Microdosing	Reduce contrast volume, improve safety	Innovate packaging and formulations.
Alternative Imaging Agents	Nanoparticles, targeted agents	May reduce overall contrast agent volumes in the future but unlikely to replace gadobutrol short-term.
Regulatory Advances	Streamlined approvals	Accelerate introduction of new pack sizes or formulations.

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What Are the Main Challenges and Risks?

Challenge/Risk	Impact	Mitigation Strategies
Pricing Pressures	Erosion of margins	Focus on value-based pricing, differentiated marketing.
Competitive Innovation	Loss of market share	Invest in further evidence generation and label extensions.
Regulatory Risks	Market access limitations	Maintain proactive compliance and ongoing safety monitoring.
Supply Chain Disruptions	Stock shortages	Diversify manufacturing, maintain safety stocks.
Gadolinium Safety Concerns	Market shift to safer agents	Emphasize gadobutrol's macrocyclic stability and safety record.

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What Is the Outlook for Market Expansion and Product Lifecycle?

• Short-Term (2023–2025): Stable growth with increasing adoption in emerging markets and ongoing use in high-end imaging.
• Mid-Term (2025–2027): Market saturation in mature regions, focus shifts to brand loyalty, new indications, and optimized packaging.
• Long-Term (Beyond 2027): Potential decline due to pipeline innovations and emerging imaging modalities; however, macrocyclic agents retain niche importance.

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Key Takeaways

• Robust Growth: MULTIHANCE MULTIPACK is positioned for steady revenue increases, driven by clinical preference for gadobutrol and expanding indications.
• Competitive Landscape: Faces significant competition from Bayer’s Gadovist and Guerbet’s Dotarem; differentiation hinges on safety profile, regulatory status, and pricing.
• Regional Dynamics: US and Europe dominate revenues; Asia-Pacific shows rapid growth potential but requires strategic localization.
• Regulatory Environment: Stable with ongoing safety evaluations favoring macrocyclic agents.
• Innovation & Market Risks: Emergence of alternative imaging modalities and regulatory shifts present both opportunities and threats.

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FAQs

1. What factors are most critical for maintaining market share for MULTIHANCE MULTIPACK?
   Clinical efficacy, safety profile, regulatory approval, competitive pricing, and physician preference.

2. How does gadolinium deposition concern influence the market?
   It favors macrocyclic agents like gadobutrol, potentially increasing demand for MULTIHANCE due to its established safety profile.

3. What are the primary regions driving growth for MULTIHANCE?
   North America and Europe are mature markets; Asia-Pacific and emerging regions offer high growth potential.

4. Are there upcoming regulatory changes that could impact sales?
   Updated safety communications and labeling adjustments are ongoing but are unlikely to restrict market access significantly.

5. What technological developments could threaten MULTIHANCE’s market position?
   Advances in non-contrast imaging (e.g., functional MRI, ultra-high field imaging) and alternative contrast agents could reduce dependency on gadobutrol.

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References

[1] Food and Drug Administration (FDA). Gadobutrol approval details. 2011.
[2] European Medicines Agency (EMA). Gadolinium-based contrast agents review. 2020.
[3] MarketsandMarkets. MRI Contrast Agents Market Analysis. 2022.
[4] IQVIA. Global pharmaceutical sales data. 2022.
[5] Gadolinium Deposition in Brain: A Review. Radiology. 2021.

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Disclaimer: Data presented are based on publicly available market research, regulatory filings, and industry estimates as of 2023 and are subject to change with evolving market conditions.