MULTIHANCE Drug Patent Profile

Which patents cover Multihance, and when can generic versions of Multihance launch?

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

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
Bracco	MULTIHANCE MULTIPACK	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021358-002	Nov 23, 2004		RX	Yes	Yes
Bracco	MULTIHANCE MULTIPACK	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021358-001	Nov 23, 2004		RX	Yes	Yes

International Patents for MULTIHANCE

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

Country	Patent Number	Title	Estimated Expiration
Japan	H0364504
Australia	2904789
Netherlands	980024
Spain	2070845
South Africa	8809597
Ireland	883844
Japan	2744920

Supplementary Protection Certificates for MULTIHANCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	99C0013	Belgium		PRODUCT NAME: GADOBENAATDIMEGLUMINE; NAT. REGISTRATION NO/DATE: 3503 IE 48 F 12 19990201; 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
0230893	SPC/GB97/081	United Kingdom		PRODUCT NAME: GADOBENATE DIMEGLUMINE; REGISTERED: UK 06099/0006 19970722

MULTIHANCE Market Analysis and Financial Projection

Last updated: April 24, 2026

MULTIHANCE (gadoversetamide): Investment Scenario and Fundamentals Analysis

MULTIHANCE is a gadolinium-based MRI contrast agent (GBCA) used for enhanced imaging in adults and pediatric patients (per labeled indications). The asset’s investment profile is shaped by patent and regulatory exclusivity positioning (brand vs. generic), its reliance on reimbursement and imaging volumes, and manufacturing supply stability for high-volume sterile injectables.

What is MULTIHANCE and how is it used in the clinic?

Product: MULTIHANCE (gadoversetamide injection)
Drug class: Gadolinium-based MRI contrast agent (GBCA)
Core use: IV contrast enhancement for MRI.

Commercial reality: MULTIHANCE competes in the GBCA market where hospital purchasing decisions weigh (1) acquisition cost, (2) dosing flexibility, (3) renal-safety workflows, and (4) formulary placement across imaging networks.

---

What are the fundamentals driving demand?

Demand for MULTIHANCE tracks tightly to MRI utilization and the clinical share of GBCA-enhanced studies.

Primary demand drivers

• MRI procedure volume growth driven by outpatient imaging expansion and adherence to imaging protocols.
• Contrast dosing patterns (standardized protocols can stabilize utilization per scan).
• Formulary access at hospital systems and imaging centers.
• Institutional safety policies for GBCA administration, especially renal impairment screening and documentation.

Key counterweights

• Switching risk to lower-cost GBCAs once brand exclusivity declines or if payers and hospital group purchasing organizations prioritize price.
• Protocol substitution where other GBCAs are preferred due to institutional experience and supply reliability.
• Regulatory and safety guidance influencing GBCA selection, documentation burden, and patient stratification.

---

How does pricing and market structure affect the investment case?

GBCA market structure

• Hospital and distributor purchasing is price-sensitive.
• Multiple GBCA competitors exist, creating direct line-of-sight substitution.
• Brand differentiation typically narrows over time as formularies normalize to standard dosing and safety workflows.

Investment implication

• Upside is constrained by the need to defend formulary share against competing GBCAs on net price.
• Downside risk rises when generics or competing brands expand share at the same care setting.

---

What is the patent and exclusivity posture likely to be for MULTIHANCE?

A defensible investment case depends on whether MULTIHANCE retains meaningful legal exclusivity against “AB-rated” alternatives at the time horizon. Patent estates for older GBCAs tend to be fragmented across:

• composition-of-matter coverage,
• method-of-use filings,
• formulation and process claims,
• and potential pediatric exclusivity or regulatory exclusivity extensions.

Market consequence

• If exclusivity has expired or is near-expiry, the asset typically faces margin compression and volume-share erosion from lower-cost entrants.
• If protection remains credible, investors can underwrite steadier net pricing and sustained hospital formulary tenure.

Actionable lens for investors

• Treat MULTIHANCE as a managed competition play rather than a durable monopoly asset.
• Value it like a sterile injectable formulary product with legal and reimbursement catalysts, not like a novel therapeutic platform.

---

What does “fundamentals” imply for profitability and cash flow?

GBCA profitability is dominated by:

• Gross margin (affected by net price after discounts and hospital contracts)
• Channel fill (supply and distribution execution)
• Regulatory compliance cost (sterile manufacturing quality systems)
• Volume stability (MRI scan volumes and contrast utilization rate)

Operational fundamentals that matter

• Manufacturing throughput and sterile fill-finish reliability
• Batch consistency for contrast performance and stability
• Recall or quality events risk for high-visibility hospital-administered injectables
• Supply continuity during transitions toward cheaper competitors

Investment implication

• Multipliers in valuation generally come from sustained net price and volume share, with downside primarily from contracting leverage shifts once competing options penetrate.

---

How should the investment scenario be framed across time?

A clean way to underwrite MULTIHANCE is to separate the horizon into legal and commercial phases.

Phase 1: Near-term commercial stability

• Expect relatively stable demand as MRI volumes rise and if formularies remain unchanged.
• Contract cycles determine realized pricing.

Phase 2: Exclusivity and competitive entry

• Model net price decline from brand competition.
• Assume share loss if lower-cost options gain formulary acceptance.

Phase 3: Mature generic/competitive landscape

• Focus on cash conversion, supply reliability, and contract retention.
• Margin becomes the main driver as volumes diversify across available GBCA choices.

Scenario logic

• If exclusivity protection is still meaningful, investors underwrite lower share loss and higher net price resilience.
• If legal protection is limited or has lapsed, investors should model faster erosion and reversion toward commodity pricing.

---

What are the principal risk factors for a GBCA investment?

1. Formulary substitution risk: hospitals and purchasing groups can switch quickly when procurement policies shift.
2. Reimbursement pressure: payer design and imaging bundle economics can push net pricing down.
3. Safety and policy tightening: renal screening protocols and contraindication guidance can change utilization patterns.
4. Manufacturing and supply shocks: sterile injectable supply disruptions can create both lost volume and reputational damage.
5. Legal timelines: patent invalidations, ANDA approvals, or settlement outcomes can accelerate price erosion.

---

What would an investor diligence plan prioritize for MULTIHANCE?

A high-signal diligence plan for a GBCA brand typically focuses on evidence that predicts contract outcomes and competitive exposure.

Commercial diligence

• Hospital system formulary penetration by region.
• Net price trends and contract discount structure.
• MRI utilization and contrast-enhanced proportion per protocol type.

Regulatory and legal diligence

• Patent list status and enforcement posture (where relevant to the relevant claim categories).
• Regulatory exclusivity clock (brand vs. generic entry timing).

Manufacturing diligence

• Quality system robustness and inspection outcomes.
• Capacity headroom and supplier concentration for critical components.

---

What are the key “fundamental” takeaways for MULTIHANCE valuation?

Base case

• MULTIHANCE is a contest for formulary share in a mature, highly substitutable GBCA segment.
• Core value comes from sustaining net pricing and preventing share erosion.

Bear case

• Faster-than-modeled competitive entry or procurement shift pressures net price.
• Margin compression outpaces volume declines.

Bull case

• Legal and commercial durability delays substitution.
• Hospital contract renewal maintains net pricing longer than competitors expect.

Underwriting posture

• Treat the asset as a managed risk investment where legal event timing and hospital contracting drive outcomes more than clinical differentiation.

---

Key Takeaways

• MULTIHANCE is a GBCA with demand tied to MRI volume and hospital formulary behavior, making it highly sensitive to competition and contract terms.
• Valuation should be driven by net price durability and formulary share retention, with key downside from rapid substitution by cheaper alternatives.
• Investor diligence should emphasize legal/exclusivity timing, hospital purchasing dynamics, and sterile manufacturing continuity.
• The asset’s risk profile matches mature sterile injectable competition, not durable platform-like growth.

---

FAQs

1) Is MULTIHANCE a standalone growth story or a market-share defense story?
It is primarily a market-share and net-price durability story, because GBCA products are directly substitutable in clinical practice.

2) What drives day-to-day commercial performance for GBCA brands like MULTIHANCE?
Hospital contracting terms, net pricing after discounts, and MRI utilization volumes.

3) What is the biggest structural risk for MULTIHANCE investors?
Formulary switching and net-price erosion when competitors gain procurement leverage.

4) How do safety and renal screening policies affect MULTIHANCE demand?
They can shift utilization patterns via administrative burden and patient selection protocols, influencing contrast use per eligible population.

5) What diligence area has the highest predictive value for returns?
Legal/exclusivity timing and hospital formulary penetration, because they determine how quickly net price declines and share losses materialize.

---

References

[1] FDA. MULTIHANCE (gadoversetamide) Prescribing Information. U.S. Food and Drug Administration.
[2] FDA. Drug Safety-related guidance and communications relevant to gadolinium-based contrast agents (GBCA class labeling and safety updates). U.S. Food and Drug Administration.
[3] EMA. Assessment and guidance on gadolinium-based contrast agents in MRI. European Medicines Agency.