MULTIHANCE MULTIPACK Drug Patent Profile

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

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

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

Summary for MULTIHANCE MULTIPACK

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for MULTIHANCE MULTIPACK

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

International Patents for MULTIHANCE MULTIPACK

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

Country	Patent Number	Title	Estimated Expiration
Japan	H0364504
Australia	2904789
Netherlands	980024

Supplementary Protection Certificates for MULTIHANCE MULTIPACK

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

MULTIHANCE MULTIPACK Market Analysis and Financial Projection

Last updated: February 4, 2026

What Are the Investment Implications for MULTIHANCE MULTIPACK?

MULTIHANCE MULTIPACK is a contrast agent marketed primarily for MRI imaging. Its investment profile depends on regulatory status, market penetration, competitive landscape, and reimbursement environment.

What is the Regulatory Status of MULTIHANCE MULTIPACK?

• Approved by the U.S. Food and Drug Administration (FDA) since 1998.
• Approved in multiple regions, including Europe, Japan, and Canada.
• Lacks recent approval amendments, indicating stable regulatory status but limited pipeline growth.
• No recent high-profile reformulations or new indications submitted, which constrains future growth.

What Is the Market Demand for MRI Contrast Agents?

• The MRI contrast agents segment is valued at approximately $2.3 billion in 2022.
• Expected compound annual growth rate (CAGR) of 3.2% from 2022 to 2027, driven by increasing MRI procedures.
• Contrast agent use remains high in oncological, neurological, and cardiovascular imaging.

How Does MULTIHANCE COMPARE to Its Competitors?

Product	Market Share (2022)	Indications	Approvals	Key Advantages
MULTIHANCE	15%	Liver, MSK, vascular	FDA, EMA, PMDA	High relaxivity, favorable safety profile
Gadavist (Gadobutrol)	22%	Neuro, vascular, cardiac	FDA, EMA, PMDA	Higher relaxivity, broader indication scope
Dotarem (Gadoterate)	10%	Neurological, cardiac	FDA, EMA, PMDA	Well-established, extensive safety data

• MULTIHANCE maintains a niche share primarily in liver imaging.
• Became less dominant after Gadavist's market entry due to higher relaxivity and broader approved indications.
• No recent label expansions or new indications have been granted for MULTIHANCE.

What Are the Key Market Drivers and Barriers?

Market Drivers

• Increasing MRI procedures driven by rising prevalence of cancer and neurological conditions.
• Growing adoption of contrast-enhanced imaging for diagnostic accuracy.
• High safety profile of multi-dose packaging, including MULTIHANCE MULTIPACK, preferred in certain hospitals.

Market Barriers

• Competition from higher-relaxivity agents offering broader indications.
• Restricted use in patients with renal impairment due to rare but serious adverse events like NSF.
• Limited pipeline growth, as the manufacturer has not introduced new formulations or significant innovations recently.

How Do Reimbursement and Pricing Impact Investment?

• Contrast agents typically have established reimbursement pathways, but pricing pressures influence revenue.
• MULTIHANCE's pricing is in line with higher-relaxivity agents but faces downward pressure from generic and biosimilar competitors for other agents.
• No significant pricing discounts or discounts for MULTIHANCE MULTIPACK have been reported, indicating stable pricing relative to competitors.

What Is the R&D and Pipeline Outlook?

• Limited pipeline activity for MULTIHANCE; no recent or upcoming formulation changes.
• The company's focus appears shifted toward other contrast agents or imaging modalities.
• The lack of pipeline activity constrains future revenue growth.

What Is the Financial Outlook?

• Revenue from contrast agents is stable but mature.
• Growth depends on volume increases rather than price.
• Limited potential for new revenue streams unless future indications or formulations are approved.

What Are the Market Risks and Opportunities?

Risks

• Regulatory changes or safety concerns could restrict use.
• Increased competition from new contrast agents or alternative imaging modalities.
• Market saturation in mature regions.

Opportunities

• Expand use in niche indications where efficacy and safety are superior.
• Potential label expansions if new clinical data arise.
• Growing MRI utilization globally, especially in emerging markets.

Key Takeaways

• INVESTORS should view MULTIHANCE MULTIPACK as a mature, stable product with niche market coverage.
• Its growth prospects are limited by the lack of recent formulary or indication expansion.
• Competitive landscape favors agents with higher relaxivity and broader indication coverage.
• Pricing stability and established reimbursement support steady revenue but restrict upside.
• Future growth hinges on clinical or regulatory breakthroughs, which appear unlikely without new development activity.

FAQs

1. Is MULTIHANCE MULTIPACK a good long-term investment? Likely suitable for risk-averse investors seeking stable revenue but not for those expecting substantial growth.

2. Could regulatory changes impact its market? Yes; safety regulations, especially relating to NSF, could influence use restrictions.

3. Are there upcoming pipeline developments? No significant updates are publicly announced; pipeline activity appears limited.

4. How does comparative relaxivity affect competitiveness? Higher relaxivity agents may provide better imaging quality, influencing market share favors.

5. What is the potential for international expansion? Growth may occur in emerging markets with increasing MRI adoption, though market penetration is still limited.

References

1. MarketWatch, 2022. MRI Contrast Agents Market Report.
2. U.S. FDA, 2023. Drug Approvals and Labeling Documents.
3. EvaluatePharma, 2022. Contrast Agent Market Share Data.
4. Agency reports from EMA and PMDA.
5. Company disclosures and annual reports, 2022.