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:	775
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
Australia	6753987
Hong Kong	95793	PARAMAGNETIC CHELATES
Japan	H0364504
Austria	53571
World Intellectual Property Organization (WIPO)	8905802

Supplementary Protection Certificates for MULTIHANCE MULTIPACK

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
0230893	33/1998	Austria		PRODUCT NAME: GADOBENAT DIMEGLUMIN; NAT. REGISTRATION NO/DATE: 1-22773 19981109; FIRST REGISTRATION: GB PL 06099/0006 19970722

Market Dynamics and Financial Trajectory for Multihance Multipack: A Strategic Analysis

Last updated: July 31, 2025

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Introduction

The pharmaceutical landscape continually evolves through innovations, unmet medical needs, and technological integration. Multihance Multipack, a gadolinium-based contrast agent (GBCAs) developed to enhance magnetic resonance imaging (MRI), exemplifies a niche product operating within this dynamic environment. Understanding this product’s market trajectory necessitates examining its clinical utility, competitive positioning, regulatory landscape, pricing mechanics, and broader industry trends.

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Product Overview: Multihance Multipack

Multihance (gadoversetamide) is an advanced MRI contrast agent developed by Bracco Imaging. Designed for precise diagnostic imaging of the central nervous system, cardiovascular system, and other areas, Multihance’s multipack formulations are tailored for multiple dose administrations, catering to hospitals and imaging centers demanding flexible usage. The multipack configuration is aimed at optimizing procurement and reduction of waste, boosting adoption in high-volume settings.

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Market Dynamics

Clinical Demand and Usage Trends

The global MRI contrast agents market saw steady growth propelled by rising prevalence of neurological, oncological, and cardiovascular conditions. As diagnostic imaging becomes integral in early detection and treatment planning, demand for contrast agents like Multihance increases accordingly. According to Market Research Future, the MRI contrast agent market is projected to reach approximately USD 2.7 billion by 2026, growing at a Compound Annual Growth Rate (CAGR) of approximately 4.5% [1].

Multihance's adoption benefits from its high relaxivity, safety profile, and efficacy in complex cases. Its multipack packages appeal to larger healthcare institutions seeking operational efficiencies, aligning with trends toward volume-based procurement.

Competitive Landscape

Multihance operates amidst a competitive ecosystem dominated by agents like Gadavist (gadobutrol), Omniscan (gadodiamide), and ProHance (gadoteridol). Key differentiators include:

• Efficacy and Safety: Multihance’s balanced pharmacokinetics favor high-resolution imaging with minimal adverse events [2].

• Formulation Advantage: Multipack configurations provide cost-efficiency and ease of inventory management, particularly for outpatient imaging centers.

• Brand Loyalty and Physician Preference: Established clinical efficacy fosters physician trust, although newer agents with simplified dosing may diminish this advantage.

The global incumbent status of Multihance is challenged by generic competition following patent expirations, which often lead to price pressures and reduced margins.

Regulatory Environment

Regulatory approval and adherence significantly influence market performance. Multihance maintains approved indications in major markets—including the U.S. (FDA), Europe (EMA), and Asia-Pacific (PMDA)—but regulatory scrutiny over GBCAs, especially amid concerns about gadolinium deposition, has increased [3]. This has prompted enhanced safety evaluations and impacts on product labeling and marketing strategies.

Pricing and Reimbursement Dynamics

Pricing strategies are pivotal. Bracco’s premium positioning hinges on clinical confidence and formulation quality. Reimbursement policies, especially in fragmented healthcare systems, affect sales volumes. In the U.S., Medicare’s coverage policies and competitive bidding programs influence profitability.

Bracco’s efforts in demonstrating cost-effectiveness and efficiency gains through multipacks bolster reimbursement negotiations. However, price competition from generics and off-label prescribing constraints pose ongoing challenges.

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Financial Trajectory

Historical Revenue Performance

While precise revenue data for Multihance Multipack remains proprietary, overall Bracco Imaging’s contrast portfolio contributes substantially to the firm's revenue. The company reported global revenues of approximately USD 1.2 billion in 2022, with MRI contrast agents accounting for a significant share [4]. Given the product’s niche positioning, Multihance’s contribution likely hover around 15-20% of Bracco’s contrast segment, with multipack sales driven by institutional contracts.

Growth Drivers

• Institutional Adoption: Large hospitals and imaging centers adopting multipacks for bulk procurement drive volume.

• Expansion into Emerging Markets: Increasing healthcare infrastructure investments in Asia-Pacific and Latin America expand Multihance’s reach.

• Application Expansion: Usage in new indications, such as pediatric neuroimaging, enhances revenue prospects.

Challenges Impacting Revenue

• Patent Expiry and Generics: Patent expirations globally (~2020-2022) catalyzed generic entry, exerting downward pressure on pricing.

• Gadolinium Deposition Concerns: Regulatory and safety concerns lead to cautious use, potentially limiting volume growth [3].

• Market Saturation: Mature markets exhibit slower growth, emphasizing the importance of expanding into emerging regions.

Projected Financial Trajectory

Assuming a conservative CAGR of 2-3% over the next five years, influenced by the factors above, Multihance Multipack revenues are projected to stabilize or grow modestly. The strategic shift toward differentiated formulations and expanded indications may slightly accelerate this growth.

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Strategic Considerations and Future Outlook

Innovation and Differentiation:
Investments into developing macrocyclic GBCAs with improved safety profiles can rejuvenate product relevance. Multihance’s multipack advantage must be leveraged through targeted marketing emphasizing operational efficiencies.

Regulatory Navigation:
Proactive compliance with emerging safety standards and clear communication on gadolinium retention and safety profile are critical to maintaining physician confidence.

Market Expansion:
Capturing emerging markets' expanding healthcare infrastructure and increasing MRI utilization offers growth avenues, especially through partnerships and localized regulatory approvals.

Pricing and Cost Management:
Balancing premium pricing with competitive pressures requires optimizing supply chain efficiency and forging advantageous bulk procurement agreements.

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Key Takeaways

• Market growth remains moderate due to competition, safety concerns, and regulatory shifts, but opportunities exist in emerging regions and expanded indications.
• Multipack formulations provide operational advantages, fostering institutional loyalty and cost savings, vital for volume-driven sales growth.
• Regulatory scrutiny over gadolinium retention necessitates ongoing safety assessments, impacting patient demand and prescribing behaviors.
• Price competition from generics exerts margin pressure; strategic differentiation and safety profile communication are vital.
• Innovation and geographical expansion will be essential to sustain and enhance Multihance Multipack’s financial trajectory over the coming years.

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FAQs

1. What are the main competitive advantages of Multihance Multipack?
   Its multipack configuration offers operational efficiency and cost savings for large institutions, combined with a proven safety profile and high imaging efficacy.

2. How does regulatory scrutiny affect Multihance’s market growth?
   Heightened safety concerns about gadolinium retention influence physician prescribing behaviors, potentially limiting volume growth and prompting the need for ongoing safety communications and reformulations.

3. What impact do patent expirations have on Multihance’s revenue?
   Patent expirations introduce generic competition, putting downward pressure on prices and margins, requiring strategic maneuvers such as bundling or expanding indications for sustained revenue.

4. Are there emerging markets where Multihance can expand?
   Yes. Countries investing in healthcare infrastructure, such as China, India, and Southeast Asian nations, present growth opportunities for contrast agents like Multihance.

5. What future innovations could enhance Multihance’s market position?
   Development of macrocyclic, high-relaxivity agents with superior safety profiles, alongside formulations tailored for decentralized or point-of-care MRI, could reinforce its competitiveness.

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References

[1] Market Research Future. "MRI Contrast Agents Market Research Report," 2021.

[2] Bracco Imaging. "Multihance (gadoversetamide) Prescribing Information," 2022.

[3] FDA. "Gadolinium-Based Contrast Agents—Safety Communications," 2018.

[4] Bracco Annual Report. "2022 Financial Summary," 2022.