Gadobenate dimeglumine - Generic Drug Details

What are the generic drug 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
University of Colorado, Denver	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	021358-001	Nov 23, 2004		RX	Yes	Yes
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-001	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	021357-003	Nov 23, 2004
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-001	Nov 23, 2004
Bracco	MULTIHANCE MULTIPACK	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021358-002	Nov 23, 2004

Gadobentate Dimeglumine (Gadobenate Dimeglumine): Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

What is gadobenate dimeglumine’s market role?

Gadobenate dimeglumine is a gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI). It is marketed as MultiHance in the US and is positioned in the MRI contrast segment alongside other non-ionic linear and macrocyclic GBCAs. Its market behavior is shaped by (1) imaging volume trends, (2) competitive substitution across GBCAs, and (3) regulatory and safety-driven procurement preferences.

How has the competitive landscape shaped pricing and share?

The competitive set for gadobenate dimeglumine is dominated by other gadolinium contrast products that win procurement based on formulary status, dosing economics, and perceived safety profiles. Over time, the market has shifted toward macrocyclic GBCAs in many institutional formularies, which impacts addressable demand and pricing power for linear agents like gadobenate dimeglumine.

Key dynamics:

• Formulary churn: Hospitals and imaging networks often revise GBCA formularies after safety communications, adverse-event surveillance, and guideline updates, leading to mix shift away from older classes.
• Bundled purchasing and group contracts: Large IDNs negotiate based on annual volume commitments; a GBCA losing a contract can experience abrupt revenue declines.
• Substitution by indication and protocol: MRI protocols allow replacement between GBCAs without changing scanner workflows, which increases competitive pressure.

What is the US product and corporate context?

MultiHance (gadobenate dimeglumine injection) is the branded product in the United States. The brand’s financial trajectory depends on US volume trends and competitive mix.

How do safety and regulatory signals affect purchasing?

GBCA procurement is sensitive to:

• Labeling and risk-management updates
• Institutional policies responding to renal impairment screening and gadolinium deposition concerns
• Patient risk segmentation by eGFR thresholds

These factors do not eliminate use of gadobenate dimeglumine, but they do shift adoption toward preferred agents in many accounts when macrocyclic options are available and clinically interchangeable in routine protocols.

What are the main demand drivers for gadobenate dimeglumine?

The revenue base for gadobenate dimeglumine is driven by:

• MRI utilization growth (imaging volume)
• Repeat imaging patterns in oncology, neurology, and musculoskeletal care
• Dose and vial utilization (price per delivered study)
• Contract retention in large imaging networks

A GBCA’s long-term trajectory is usually more dependent on institutional contract dynamics and mix than on “new use” claims, since GBCA indications are relatively stable.

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Financial Trajectory: Revenue, Profit Pool Exposure, and Positioning

What does the brand’s financial profile typically look like?

Gadobenate dimeglumine is a legacy MRI contrast brand in an increasingly contract-driven GBCA market. For mature imaging agents like this, financial trajectory usually shows:

• Moderate baseline revenue tied to installed imaging demand
• Periodic step-downs when procurement shifts away to competing GBCA products
• Erosion from generic or alternative branded competitors depending on local market structure

What specific financial direction applies to gadobenate dimeglumine?

Because the US GBCA market is heavily influenced by competitive substitution and formulary preference, the brand’s typical financial path is:

• Peak years followed by mix decline as macrocyclic GBCAs and other alternatives consolidate share
• Stabilization attempts via account-level retention and contract renegotiations
• Downward pressure on realized pricing through competitive bidding and tendering cycles

Where is the financial risk concentrated?

Financial risk concentrates in:

• Institutional contract losses (multi-year hospital system decisions)
• Conversion to alternative GBCAs in neurology and oncology imaging protocols
• Pricing pressure as competitors adjust bid strategies

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Market Microeconomics: Pricing, Tenders, and Volume

How do per-study economics work for GBCAs?

For GBCA brands, revenue is driven by:

• Units shipped per MRI exam
• Single-dose vial or multi-dose regimen conversion
• Net pricing after rebates under group purchasing and tender contracts

In practice, the same MRI scan can use different contrast agents. That makes the market less tolerant of price premiums over time unless a product has a strong formulary advantage or distinct protocol requirement.

What procurement levers decide winners in GBCA markets?

Procurement tends to select through:

• Formulary status (preferred vs non-preferred)
• Contract price and rebate structure
• Clinical pathway fit for repeat dosing schedules and patient screening workflows
• Availability and supply reliability (especially for single-source brands)

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Strategic Outlook: What will shape the next 3 to 5 years?

Will gadobenate dimeglumine face further share erosion?

Share erosion remains plausible because:

• Macrocyclic GBCAs have continued to gain formulary share in many settings
• Competitive substitution is operationally easy for MRI
• Institutional risk policies increasingly standardize on preferred GBCAs for certain patient categories

What growth upside still exists?

Upside is most likely where:

• The product retains preferred status via long-standing network contracts
• The hospital system’s GBCA mix remains stable due to switching friction
• The product maintains favorable net pricing versus close comparators

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Key Takeaways

• Gadobenate dimeglumine is a mature MRI contrast brand in a market that increasingly favors competitive GBCA substitution and formulary-driven procurement.
• Pricing power typically weakens as institutional tenders consolidate around preferred agents, especially when macrocyclic alternatives are accessible.
• Financial trajectory is more sensitive to contract retention and mix shift than to incremental indication expansion.
• The near-term outlook is dominated by hospital formulary decisions, safety-driven patient risk segmentation, and tender economics.

FAQs

1) What is gadobenate dimeglumine used for?

It is a gadolinium-based MRI contrast agent used to enhance imaging in diagnostic MR exams.

2) What is the biggest determinant of its financial performance?

Institutional purchasing outcomes, especially formulary status and contract pricing, which drive both volume and realized net revenue.

3) Is it competing against newer GBCA categories?

Yes. It competes against other branded and alternative GBCA agents, with many institutions shifting preference toward macrocyclic agents.

4) What market forces most affect its realized price?

Group purchasing, rebates, and competitive tender cycles that compress net pricing over time.

5) What should guide an R&D or investment view of this segment?

Track formulary trends, contract expirations, and safety-policy impacts on GBCA selection by patient risk profile.

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References (APA)

[1] Food and Drug Administration. (n.d.). MultiHance (gadobenate dimeglumine) prescribing information. FDA.
[2] U.S. National Library of Medicine. (n.d.). MultiHance (gadobenate dimeglumine) drug information. DailyMed.
[3] European Medicines Agency. (n.d.). Assessment reports and recommendations for gadolinium-based contrast agents. EMA.