MULTIHANCE Drug Patent Profile

Which patents cover Multihance, and what generic alternatives are available?

Multihance is a drug marketed by Bracco and is included in two NDAs.

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

Summary for MULTIHANCE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Patent Applications:	615
Drug Prices:	Drug price information for MULTIHANCE
What excipients (inactive ingredients) are in MULTIHANCE?	MULTIHANCE excipients list
DailyMed Link:	MULTIHANCE at DailyMed

See drug prices for MULTIHANCE

Pharmacology for MULTIHANCE

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

US Patents and Regulatory Information for MULTIHANCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-001	Nov 23, 2004		RX	Yes	Yes
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-004	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 MULTIHANCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-001	Nov 23, 2004	4,916,246
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-003	Nov 23, 2004	4,916,246
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-004	Nov 23, 2004	4,916,246
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-002	Nov 23, 2004	4,916,246

International Patents for MULTIHANCE

See the table below for patents covering MULTIHANCE around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	120191
Austria	53571
Australia	2904789
Australia	591225

Supplementary Protection Certificates for MULTIHANCE

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

MULTIHANCE (gadobenate dimeglumine) market dynamics and financial trajectory: pricing, utilization, channel mix, and exclusivity/patent-driven competitive risk

Last updated: June 19, 2026

MULTIHANCE is a gadolinium-based contrast agent (GBCA) for MRI. The commercial trajectory is dominated by: (1) GBCA class-level demand tied to MRI volumes, (2) managed-care and hospital contracting that pressures unit price, (3) increasing channel preference for lower-cost competitors, and (4) patent and regulatory exclusivity status that drives generic and branded substitution risk. In the absence of disclosed company-by-company unit or revenue reporting in the underlying record here, the most decision-relevant dynamic is the risk profile for GBCA pricing and volume share under competitive entry, driven by patent estate strength and Orange Book status.

What is the market size and growth profile for MULTIHANCE (gadobenate dimeglumine) in MRI contrast?

Short answer: MULTIHANCE tracks MRI contrast utilization, with growth shaped by MRI volume expansion and countered by budget pressure and formulary substitution across the GBCA class.

GBCA class demand drivers that set MULTIHANCE ceiling

GBCA demand is primarily driven by MRI exam growth and scanning protocols that specify contrast-enhanced imaging. Key end-market channels include:

• Hospital outpatient departments
• Hospital inpatient radiology
• Free-standing imaging centers (FICs) with contract purchasing

MRI volume growth typically supports volume, but GBCA spend growth depends on negotiated pricing and volume allocation across competitors. Under pressure, hospitals re-balance selection toward lowest total cost per mL and toward supply reliability.

What usually determines MULTIHANCE unit share in practice

For GBCA procurement, decision-makers typically use:

• Contract pricing tiers and group purchasing organization (GPO) benchmarks
• Formulary placement (preferred vs non-preferred)
• Clinical committee preferences for dose efficiency, image quality, and workflow
• Supply continuity and inventory management requirements
• Annual utilization commitments and service-level agreements

MULTIHANCE’s financial outcome in this market is therefore a function of negotiated price elasticity and retention in “preferred” tiers versus replacement with lower-cost GBCA options.

How do competitors in the gadolinium MRI contrast market affect MULTIHANCE revenue trajectory?

Short answer: Revenue trajectory is exposed to branded and generic GBCA substitution as purchasing committees optimize for cost and supply. Competitive entry typically compresses pricing and forces share migration.

Primary substitution set for MULTIHANCE in MRI contrast formularies

Clinically, GBCA selection is often driven by:

• Chelate chemistry and dosing patterns
• Institutional preference and radiology practice guidelines
• Supply performance and contracting

Commercially, substitution risk comes from:

• Lower net pricing of competing products
• Increased generic availability for GBCA active ingredients and presentations
• Competitive rebates and contracting pressure

Channel mix: where substitution hits hardest

• Hospital systems with centralized pharmacy and purchasing are the fastest to shift unit volume to preferred alternatives when contract pricing changes.
• FICs that operate with tighter margins respond quickly to net price offers.
• Per-exam utilization may remain stable, but which GBCA is used can change at the margin, shifting revenue away from higher-priced brands.

What pricing and contracting dynamics drive MULTIHANCE financial performance?

Short answer: Net price is typically the key driver of profitability, with utilization influenced by MRI volume while price erosion is driven by hospital contracting dynamics.

Net price mechanics that determine the “financial trajectory”

MULTIHANCE performance generally reflects:

• Wholesale acquisition cost (WAC) declines or stability versus net realizations (rebates, discounts)
• Contract-specific net pricing after formulary decisions
• Quarterly purchasing patterns tied to contract renewals

Even if unit volume is stable, revenue can fall if net prices compress. Conversely, if MULTIHANCE retains preferred status through service, imaging outcomes, or supply reliability, revenue decline can be slower than class averages.

Cost containment pressure across GBCA budgets

Hospitals face radiology spend caps and budget review cycles. GBCA procurement often becomes a line-item target during:

• Fiscal year contract renewals
• Pharmacy and therapeutics committee cost reviews
• Budget reallocation after re-pricing of adjacent imaging products

This produces a typical pattern in the GBCA market: slower or plateaued volume with faster net price erosion when competitors offer lower contracted pricing.

When does MULTIHANCE lose exclusivity and how does patent expiration affect competitive entry risk?

Short answer: Exclusivity and patent expiration determine the timing of generic or interchangeable competition. The highest commercial risk window aligns with the effective date of regulatory entry and any paragraph IV-driven settlements.

Patent and exclusivity mapping required for launch-risk decisions

For a decision-grade assessment of entry timing, you need the Orange Book listing details (patent numbers, expiration dates, and exclusivity codes) and any litigation history. That granular mapping is not available in the provided record, so a specific calendar timeline cannot be stated here.

What is the Orange Book status of MULTIHANCE and what patents are listed?

Short answer: Orange Book status and listed patents are determinative for generic entry sequencing. The specific listing for MULTIHANCE is not present in the supplied material, so it cannot be reproduced accurately.

What patent litigation affects MULTIHANCE generic entry, including Paragraph IV challenges and settlements?

Short answer: Paragraph IV litigation can accelerate generic entry through court outcomes or settlement launch dates. Litigation-specific details are not present in the provided record.

How litigation outcomes translate to revenue impact

In GBCA markets, revenue pressure generally increases when:

• A generic achieves a favorable court outcome or enters via settlement date
• A competitor receives exclusivity for an abbreviated approval pathway
• Multiple entry products appear in the same dosing strength/presentation set

Without case-specific dates and outcomes, the timing and magnitude cannot be quantified from the current record.

What generic entry risks exist for MULTIHANCE by presentation (vials, strengths) and dosing patterns?

Short answer: Risk is driven by whether competitors can launch across equivalent strength and package sizes that match how hospitals bill and stock contrast kits.

Entry risks that matter commercially

• Competitive launch for only one strength can still shift volume if formularies standardize dosing.
• Supply chain availability affects whether substitution is immediate or delayed.
• Substitution friction rises when institutions have vial-size preferences, workflow constraints, or adverse experience with alternatives.

Without the specific presentation-level Orange Book mapping, no presentation-by-presentation launch risk can be stated.

How does MULTIHANCE compare with other GBCA brands and generics on market dynamics?

Short answer: In MRI contrast, brands compete on institutional preference and net pricing; generics compete on net cost and contracting leverage. The class’s pricing floor is often set by the most aggressive entrant.

Comparative dynamics that affect share

• Preferred formulary placement can stabilize branded share.
• Contracting cadence and group purchasing terms control how quickly substitution occurs.
• Radiology committee preference can delay switching, even when net cost favors alternatives.

What manufacturing and supply issues can influence MULTIHANCE revenue beyond patents?

Short answer: Supply reliability and lot availability can change purchasing behavior even when net pricing is comparable.

Key supply factors affecting GBCA channel behavior

• Inventory availability for scheduled MRI throughput
• Ability to fulfill hospital multi-site demand
• Distribution reliability for outpatient and inpatient imaging units

Supply disruptions can temporarily protect a higher-priced brand by delaying substitution, but sustained allocation issues can also accelerate diversification across suppliers.

What does the financial trajectory likely look like for MULTIHANCE under competitive pricing?

Short answer: The trajectory is typically characterized by revenue compression post-peak as competition grows, with volume stability if MRI contrast utilization holds. Net price erosion usually dominates.

Three-stage commercial pattern seen in many GBCA trajectories

1. Early competition: net price declines modestly while volume is retained.
2. Preferred tier loss: unit share shifts to lower-cost alternatives; revenue drops faster than volume.
3. Consolidation: the market settles into a preferred-lower-cost band; branded products either retain niche share or continue pricing erosion.

A decision-grade forecast requires specific Orange Book and entry dates plus historical net sales by quarter, none of which are in the current record.

Key takeaways for market and financial trajectory planning

• MULTIHANCE’s revenue path is primarily shaped by MRI demand and GBCA class contracting dynamics, with net price pressure as the main risk.
• Competitive exposure is driven by patent and regulatory status that determines generic entry timing and breadth across presentations.
• Hospital purchasing shifts fastest at contract renewals and formulary decisions, so revenue risk concentrates around entry and settlement-effective dates.
• Supply reliability can temporarily offset pricing pressure, but long-term outcomes track net cost competitiveness and formulary placement.

FAQs

1) What drives hospital formulary selection for gadolinium MRI contrast agents like MULTIHANCE?
Net price under contract, preferred formulary tier placement, radiology committee practice patterns, and supply reliability.

2) How does MRI procedure volume translate into GBCA demand for brands such as MULTIHANCE?
Demand tracks contrast-enhanced MRI utilization; overall MRI growth supports volume, while product selection determines brand-level share and revenue.

3) What contract mechanisms most strongly affect MULTIHANCE net pricing?
GPO benchmarks, system-wide centralized purchasing, rebates/discounts tied to utilization, and contract tiering.

4) What is the highest-risk period for MULTIHANCE revenue tied to generic entry?
The period around effective generic approval/launch and any settlement-determined entry dates, when hospitals re-tier formulary and purchasing.

5) Do supply disruptions change long-term MULTIHANCE market outcomes?
They can affect short-term volume and allocation, but durable share shifts typically follow contracting and pricing once competitors are available.

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book).
2. FDA. Drug Approval Reports / Drug Trials Snapshots (where applicable). (Accessed via FDA databases).