PROHANCE MULTIPACK Drug Patent Profile

Which patents cover Prohance Multipack, and what generic alternatives are available?

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

The generic ingredient in PROHANCE MULTIPACK is gadoteridol. Two suppliers are listed for this compound. Additional details are available on the gadoteridol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prohance Multipack

A generic version of PROHANCE MULTIPACK was approved as gadoteridol by HAINAN POLY on February 11^th, 2025.

Summary for PROHANCE MULTIPACK

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	9
Patent Applications:	1,021
DailyMed Link:	PROHANCE MULTIPACK at DailyMed

Recent Clinical Trials for PROHANCE MULTIPACK

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

Sponsor	Phase
University of Alabama at Birmingham	Early Phase 1
University of Alabama at Birmingham	Phase 1
IQVIA (Sponsor)	Phase 4

See all PROHANCE MULTIPACK clinical trials

Pharmacology for PROHANCE MULTIPACK

Drug Class	Paramagnetic Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity

US Patents and Regulatory Information for PROHANCE MULTIPACK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003		RX	Yes	Yes

Expired US Patents for PROHANCE MULTIPACK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003	4,885,363
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003	6,143,274
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003	5,846,519
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003	5,474,756

International Patents for PROHANCE MULTIPACK

See the table below for patents covering PROHANCE MULTIPACK around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	3772785
Germany	3855451
Japan	S6452764	1-SUBSTITUTED 1,4,7-TRISCARBOXYMETHYL-1,4,7,10- TETRAAZACYCLODODECANE AND ANALOGUE
Japan	S62190175	1-SUBSTITUTED-1,4,7-TRISCARBOXYMETHYL-1,4,7,10- TETRAAZACYCLODODECANE AND ANALOGUE

Market Dynamics and Financial Trajectory for PROHANCE MULTIPACK

Last updated: July 29, 2025

Introduction

ProHance Multipack is a diagnostic agent primarily used in neuroimaging procedures to enhance magnetic resonance imaging (MRI) of the brain and central nervous system (CNS). As a gadolinium-based contrast agent (GBCA), its clinical utility hinges on its ability to improve diagnostic accuracy and patient management. Understanding the evolving market landscape and financial outlook for PROHANCE Multipack involves analyzing key drivers, competitive forces, regulatory environment, and technological advancements.

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Market Overview of Gadolinium-Based Contrast Agents

The global gadolinium-based contrast agent (GBCA) market is projected to grow at a compound annual growth rate (CAGR) of approximately 4–6% over the next five years, reflecting increasing MRI utilization, technological innovations, and growing prevalence of neurological disorders [1]. GBCAs account for a significant share of global diagnostic imaging revenues, with multipack offerings like PROHANCE designed to meet high-volume hospital and radiology center demands.

Factors fueling this expansion include:

• Rising incidence of stroke, brain metastases, multiple sclerosis, and neurodegenerative diseases.
• Greater adoption of MRI as a preferred imaging modality over CT for neurological assessments.
• Increasing healthcare expenditure and investments in advanced diagnostic infrastructure.

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Market Drivers for PROHANCE Multipack

1. Clinical Efficacy and Safety Profile

PROHANCE’s high relaxivity (a measure of contrast-enhancing efficacy) and well-characterized safety profile facilitate its preference among radiologists [2]. The multipack format enables high-volume use, aligning with the needs of busy clinical settings.

2. Growing Neuroimaging Demand

Neurological conditions—especially stroke, tumor assessment, and inflammatory diseases—drive increased MRI procedures. The multipack configuration supports large institutional use, reducing logistical hurdles and enhancing operational efficiency.

3. Regulatory and Reimbursement Trends

Regulatory agencies such as the FDA recognize the importance of contrast agents in accurate diagnosis; insurers increasingly reimburse high-volume contrast use, favoring multipack formats to lower per-use costs.

4. Competitive Differentiation

PROHANCE’s unique properties—such as its high relaxivity and favorable safety profile—differentiate it from competitors like Dotarem and Gadavist. Multipack formulations position it as a cost-effective, volume-efficient choice for healthcare providers.

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Competitive Landscape

The GBCA market involves multiple key players:

• Gadavist (gadobutrol) by Bayer
• Dotarem (gadoterate meglumine) by Guerbet
• ProHance (gadoteridol) by Bracco

Market Positioning of PROHANCE Multipack:

While PROHANCE maintains a solid position, it faces intense competition. Bayer and Guerbet have developed innovative formulations with similar or improved safety profiles. The multipack offering serves as a strategic response, aiming to lock in institutional clients through volume-based pricing and bulk procurement contracts.

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Regulatory Environment and Impact

Regulatory scrutiny over gadolinium retention and deposition in tissues has impacted market dynamics. The European Medicines Agency (EMA) and FDA have issued safety advisories, prompting manufacturers to highlight safety profiles and develop macrocyclic agents with lower gadolinium retention tendencies [3].

PROHANCE, being a linear agent, has experienced increased competition from macrocyclic counterparts. Nonetheless, its longstanding clinical use and established safety profile contribute to sustained demand, especially in North America and certain Asian markets.

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Technological and Innovation Trajectory

Emerging innovations include:

• Organic Gadolinium-Free Contrast Agents: Research into alternative agents reducing gadolinium deposition.
• Dose Optimization Protocols: AI-driven imaging protocols aim to minimize contrast volume without compromising image quality, which could influence volume demand per procedure but may increase overall procedure numbers.
• Multipack and Bulk Supply Chains: Enhanced manufacturing efficiencies and supply chain management bolster PROHANCE’s marketability in institutional settings.

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Financial Trajectory and Revenue Outlook

Revenue Projections

Analyzing the current market parameters, the revenue trajectory for PROHANCE Multipack hinges on:

• Market Penetration: Institutional contracts and hospital procurement policies favor multipack formats.
• Pricing Strategies: Volume discounts and bundled contracts influence revenue per unit.
• Growth in MRI Procedures: A projected 5% annual increase in neuroimaging procedures bolsters the total antidepressant need for contrast agents.

Portraying a conservative growth estimate, revenues for PROHANCE Multipack can be expected to increase at a CAGR of approximately 4–6% over the next five years, aligning with industry forecasts [1].

Cost Dynamics

Manufacturing and distribution costs for multipacks tend to decrease per unit with higher volume production, improving margins. However, regulatory compliance costs related to safety concerns may offset some efficiencies.

Risk Factors

• Safety Concerns: Gadolinium retention issues may lead to reduced usage or shifts toward macrocyclic agents, impacting sales.
• Pricing Pressures: Competitive offerings and healthcare cost containment efforts could compress margins.
• Regulatory Restrictions: Potential restrictions or bans on linear agents could reshape market dynamics.

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Strategic Recommendations

• Enhance Safety Profile Communication: Highlighting PROHANCE's safety and efficacy is crucial in maintaining market share amid regulatory pressures.
• Focus on Institutional Sales: Strengthening relationships with hospitals and imaging centers will promote multipack adoption.
• Invest in Innovation: Developing macrocyclic formulations or dose-sparing protocols can future-proof against regulatory challenges.
• Expand Geographic Reach: Increasing penetration in emerging markets with expanding healthcare infrastructure can bolster revenues.

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Key Takeaways

• The market for PROHANCE Multipack is driven by rising MRI use in neurodiagnostics, with sustained growth prospects underpinned by increased neurological disorder prevalence.
• Competitive differentiation hinges on safety, efficacy, and cost-effective bulk supply, positioning PROHANCE favorably within existing competitive tensions.
• Regulatory and safety concerns may pose risks but can be mitigated through strategic communication and product positioning.
• Revenue growth is anticipated at a conservative CAGR of 4–6% over the next five years, contingent on market adoption and regulatory developments.
• Strategic focus on innovation, institutional sales, and geographic expansion will optimize sales trajectories.

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FAQs

1. How does PROHANCE Multipack compare with macrocyclic contrast agents in safety profiles?
PROHANCE (gadoteridol) is a linear gadolinium-based agent. Macrocyclic agents like Gadavist and Dotarem have demonstrated lower gadolinium retention, leading to increased regulatory favorability. While PROHANCE maintains a strong safety profile, macrocyclic agents are increasingly preferred in certain regions.

2. What factors could hinder the growth of PROHANCE Multipack?
Regulatory restrictions on linear gadolinium agents, safety concerns regarding gadolinium retention, and intensified competition from macrocyclic formulations could impact sales.

3. Which geographic markets offer the highest growth potential for PROHANCE?
North America and Europe are mature but continue to offer opportunities through institutional procurement. Emerging markets in Asia-Pacific present high growth potential due to expanding healthcare infrastructure.

4. How have safety concerns regarding gadolinium influenced the market?
Safety alerts have prompted providers to reconsider contrast agent choices, favoring macrocyclic agents. This shift could reduce demand for linear agents like PROHANCE unless safety profiles are effectively communicated and additional safety measures are implemented.

5. What are the key technological advancements shaping the interim future of neuroimaging contrast agents?
Advancements include dose-sparing protocols, AI-enhanced imaging, and development of non-gadolinium agents, which may influence future demand patterns for traditional contrast media such as PROHANCE.

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Sources

[1] MarketsandMarkets. Gadolinium-Based Contrast Agents Market Forecast. 2022.
[2] Bracco. PROHANCE Product Information. 2023.
[3] EMA. Gadolinium Retention Advisory. 2022.