GADOBENATE DIMEGLUMINE - Generic Drug Details

What are the generic sources for gadobenate dimeglumine and what is the scope of freedom to operate?

Gadobenate dimeglumine is the generic ingredient in two branded drugs marketed by Bracco and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for GADOBENATE DIMEGLUMINE

US Patents:	0
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	17
What excipients (inactive ingredients) are in GADOBENATE DIMEGLUMINE?	GADOBENATE DIMEGLUMINE excipients list
DailyMed Link:	GADOBENATE DIMEGLUMINE at DailyMed

Recent Clinical Trials for GADOBENATE DIMEGLUMINE

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

Sponsor	Phase
Bracco Imaging S.p.A.	PHASE3
University of California, San Diego	PHASE3
National Cancer Institute (NCI)	Phase 4

See all GADOBENATE DIMEGLUMINE clinical trials

Pharmacology for GADOBENATE DIMEGLUMINE

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

US Patents and Regulatory Information for GADOBENATE DIMEGLUMINE

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	021358-002	Nov 23, 2004		RX	Yes	Yes
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-002	Nov 23, 2004		RX	Yes	Yes
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-003	Nov 23, 2004		RX	Yes	Yes

Expired US Patents for GADOBENATE DIMEGLUMINE

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 MULTIPACK	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021358-002	Nov 23, 2004
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-004	Nov 23, 2004

Market Dynamics and Financial Trajectory for Gadobenate Dimeglumine

Last updated: July 30, 2025

Introduction

Gadobenate dimeglumine, marketed under the brand name MultiHance, is a gadolinium-based contrast agent (GBCA) used primarily in magnetic resonance imaging (MRI). Approved by regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), this agent enhances imaging clarity, aiding in the diagnosis of neurological, musculoskeletal, and vascular conditions. Its unique pharmacokinetic profile, characterized by partial hepatobiliary excretion, distinguishes it from other GBCAs, influencing its market penetration and financial prospects.

This analysis explores the market dynamics surrounding gadobenate dimeglumine, examining key factors such as technological competition, regulatory pathways, pricing strategies, and emerging trends affecting its financial trajectory.

Market Landscape and Key Players

Gadobenate dimeglumine is part of a competitive landscape comprising various MRI contrast agents, including macrocyclic GBCAs like gadoterate meglumine (Dotarem) and gadobutrol (Gadavist), as well as linear agents such as gadopentetate dimeglumine (Magnevist). Its primary competitors are these agents' widespread adoption, driven by their established safety profiles, regulatory approvals, and clinician familiarity.

Bayer Healthcare, the original developer and marketer of MultiHance, remains a notable player, although market shares have shifted with the introduction of newer agents and increasing scrutiny of gadolinium deposition risks.

Market Dynamics Driving Adoption

Technological Differentiation and Clinical Efficacy

Gadobenate dimeglumine’s partial hepatobiliary excretion enhances its utility in liver imaging, offering superior lesion detection compared to agents lacking this property. This differentiation fosters niche applications, particularly in hepatobiliary MRI, where it commands a premium. Its higher relaxivity (approximately 4-5 times that of some linear agents) enhances image quality at lower doses, contributing to superior diagnostic performance.

Regulatory Impact and Approvals

Regulatory environments significantly influence market dynamics. While gadobenate dimeglumine has secured approvals in major markets, recent regulatory reviews—prompted by concerns about gadolinium retention—have imposed new guidelines and restrictions on GBCAs, especially linear agents. The European Medicines Agency’s (EMA) restrictions prompted some healthcare providers to favor macrocyclic agents, which are perceived as safer. These regulatory shifts pose challenges but also create opportunities for gadobenate dimeglumine in specific clinical niches where its benefits outweigh perceived risks.

Safety Profile and Gadolinium Deposition Concerns

Growing evidence of gadolinium deposits in brain tissue, primarily associated with linear GBCAs, has led to increased clinician and regulatory scrutiny. Macrocyclic agents with stable chelation, such as gadoterate meglumine, are gaining favor, but gadobenate dimeglumine’s partial hepatobiliary excretion and clinical utility in liver imaging sustain its relevance. Manufacturers are investing in post-marketing studies to bolster safety profiles, influencing market acceptance.

Pricing and Reimbursement Climate

Pricing strategies for gadobenate dimeglumine are influenced by cost-effectiveness, reimbursement policies, and competitive positioning. As healthcare systems seek cost containment, high-priced agents face pressure, especially if efficacy differences are marginal. However, its high relaxivity and application-specific benefits justify premium pricing in niche markets, aiding revenue stability.

Emerging Trends: Biosimilars and New Agents

The entry of biosimilar GBCAs and the development of new contrast formulations influence the market landscape. While no biosimilars currently target gadobenate dimeglumine directly, the proliferation of alternative agents could diminish its market share. Conversely, advances in non-gadolinium-based imaging or novel contrast mechanisms may reshape future diagnostic paradigms, impacting revenue streams.

Financial Trajectory Analysis

Revenue Streams and Market Penetration

Gadobenate dimeglumine’s revenues are concentrated within specialized MRI applications, notably hepatobiliary imaging. As of recent years, global sales demonstrate moderate growth, buoyed by clinical demand for high-resolution liver MRI. The agent’s premium positioning sustains healthy margins where niche adoption persists.

Market Challenges

The principal constraints involve increasing regulatory restrictions, safety concerns about gadolinium deposition, and competition from macrocyclic agents. These factors dampen growth prospects, prompting the need for strategic positioning.

Growth Opportunities

Opportunities for growth include:

• Expanding indications for gadobenate dimeglumine in neurology and oncology, leveraging its high relaxivity.
• Developing compliant formulations aligning with evolving safety standards.
• Geographic expansion into emerging markets with growing healthcare infrastructure.

Forecasting Outlook

Long-term financial performance hinges on regulatory adaptation, continued clinical efficacy demonstration, and strategic marketing. While near-term growth may plateau due to regulatory headwinds and competition, niche applications and clinical differentiation sustain revenue streams. A projected moderate compound annual growth rate (CAGR) of approximately 2-4% over the next five years appears plausible, contingent on regulatory and clinical acceptance.

Regulatory and Market Risks

Risks include the potential imposition of further restrictions, declining clinician preference for gadolinium agents amid safety concerns, and the commodification of contrast agents due to biosimilar proliferation. These factors could pressure prices and volumes, necessitating ongoing innovation and safety validation.

Conclusion

Gadobenate dimeglumine occupies a strategic but challenged segment in the MRI contrast agent market. Its unique pharmacological profile offers sustained niche relevance, particularly in liver imaging, underpinning its modest but stable financial trajectory. Navigating regulatory landscapes, addressing safety perceptions, and innovating for broader clinical application are essential for maximizing its market potential.

---

Key Takeaways

• Gadobenate dimeglumine maintains niche dominance in hepatobiliary MRI due to its partial hepatobiliary excretion and superior relaxivity.
• Regulatory scrutiny surrounding gadolinium-based agents—especially linear GBCAs—poses ongoing challenges, but gadobenate’s stability and targeted use cases bolster its resilience.
• Competitive pressures from macrocyclic agents and biosimilars require continuous safety validation and differentiation.
• Growth prospects depend on geographic expansion, indications diversification, and addressing safety concerns.
• Strategic adaptation to regulatory trends and clinical evidence will be critical in shaping the agent’s financial trajectory over the next five years.

---

FAQs

1. What distinguishes gadobenate dimeglumine from other gadolinium-based contrast agents?
   Its partial hepatobiliary excretion and higher relaxivity enable superior liver lesion detection and imaging at lower doses, providing clinical advantages in hepatobiliary MRI.

2. How have safety concerns about gadolinium retention affected gadobenate dimeglumine’s market?
   Despite concerns, gadobenate’s stability and clinical utility have helped sustain its niche, though overall demand for GBCAs is shifting toward macrocyclic agents perceived as safer.

3. What are the primary applications driving demand for gadobenate dimeglumine?
   Liver imaging, especially in patients requiring dynamic contrast-enhanced MRI for lesion characterization, remains its core application.

4. Are biosimilars impacting gadobenate dimeglumine’s market share?
   Currently no biosimilars directly compete with gadobenate, but generic developments of other GBCAs could exert downward price pressure.

5. What future trends could influence gadobenate dimeglumine’s financial outlook?
   Evolving safety regulations, emergence of alternative imaging modalities, and increased clinician preference for macrocyclic agents will significantly impact its market performance.

---

Sources

1. [1] FDA Approval Document for MultiHance (gadobenate dimeglumine).
2. [2] EMA Gadolinium-Based Contrast Agents Review.
3. [3] Choi, J., et al. “Gadolinium Deposition and Safety Data in MRI Contrast Agents,” Radiology, 2022.
4. [4] Bayer Healthcare Corporate Reports, 2023.
5. [5] Market research reports on MRI contrast agents, 2022–2023.