MAGNEVIST Drug Patent Profile

When do Magnevist patents expire, and what generic alternatives are available?

Magnevist is a drug marketed by Bayer Hlthcare and is included in two NDAs.

The generic ingredient in MAGNEVIST is gadopentetate dimeglumine. There is one drug master file entry for this compound. Additional details are available on the gadopentetate dimeglumine profile page.

Summary for MAGNEVIST

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	30
Patent Applications:	2,710
Drug Prices:	Drug price information for MAGNEVIST
What excipients (inactive ingredients) are in MAGNEVIST?	MAGNEVIST excipients list
DailyMed Link:	MAGNEVIST at DailyMed

See drug prices for MAGNEVIST

Recent Clinical Trials for MAGNEVIST

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

Sponsor	Phase
Dipan Shah	N/A
Guerbet	N/A
Astellas Pharma Inc	Phase 4

See all MAGNEVIST clinical trials

US Patents and Regulatory Information for MAGNEVIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	019596-001	Jun 2, 1988		DISCN	Yes	No
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	021037-001	Mar 10, 2000		DISCN	Yes	No

Expired US Patents for MAGNEVIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	021037-001	Mar 10, 2000	5,362,475
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	019596-001	Jun 2, 1988	4,647,447
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	019596-001	Jun 2, 1988	5,560,903
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	021037-001	Mar 10, 2000	4,963,344
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	021037-001	Mar 10, 2000	4,647,447
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	021037-001	Mar 10, 2000	4,957,939

International Patents for MAGNEVIST

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

Country	Patent Number	Title	Estimated Expiration
Ireland	53639	PARAMAGNETIC COMPLEX SALTS, THEIR PREPARATION, AND THEIR USE IN NMR-DIAGNOSTICS
Australia	1018488
Ireland	840126
Finland	840226
United Kingdom	2169598	PHYSIOLOGICALLY TOLERABLE METAL COMPLEX SALTS FOR USE IN NMR DIAGNOSIS
Portugal	77983	DIAGNOSTISCHE MITTEL

Supplementary Protection Certificates for MAGNEVIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0071564	SPC/GB93/060	United Kingdom

Market Dynamics and Financial Trajectory for MAGNEVIST (Gadopentetate Dimeglumine)

Last updated: January 13, 2026

Executive Summary

MAGNEVIST (gadopentetate dimeglumine) is a gadolinium-based contrast agent (GBCA) primarily used in magnetic resonance imaging (MRI). Designed to enhance image clarity and diagnostic accuracy, MAGNEVIST represents a critical segment within the global contrast agents market. Over recent years, the drug has experienced varying demand influenced by emerging safety profiles, regulatory shifts, technological advances, and competitive landscape modifications. This analysis explores the current market environment, underlying drivers and challenges, and projects MAGNEVIST’s financial trajectory within the broader context of MRI contrast agents.

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Market Overview: The Role of MAGNEVIST in Diagnostic Imaging

What is MAGNEVIST?

Parameter	Description
Active Ingredient	Gadopentetate Dimeglumine
Drug Class	Gadolinium-based contrast agent (GBCA)
Primary Use	MRI contrast enhancement
Approval Date	1988 (by FDA)
Manufacturers	Guerbet, Bayer AG under legacy licensing, others

MAGNEVIST was among the pioneering GBCAs, heralding a significant leap in non-invasive diagnostic imaging. Its efficacy in delineating vascular and soft tissue structures solidifies its role in neurological, musculoskeletal, and oncological imaging.

Market Share and Positioning

As of 2022, MAGNEVIST maintains a significant share in the GBCA market, although its position is evolving due to safety concerns associated with gadolinium retention and alternatives like macrocyclic agents.

Market Share (2022)	Estimated
Global GBCA Market	Approximately USD 2.8 billion
MAGNEVIST's Share	Approx. 8-12%

Source: [1], [2]

Key Competitors

Product	Type	Market Position	Notes
Dotarem (Gadoterate meglumine)	Macrocyclic GBCA	Growing due to safety profile	Approved in over 70 countries
Gadavist (Gadobutrol)	Macrocyclic GBCA	High relaxivity	Approved for CNS, body, and angiography
Omniscan (Gadodiamide)	Linear GBCA	Declining	Safety concerns and withdrawal in some regions
MultiHance (Gadoteridol)	Macrocyclic GBCA	Niche markets	Limited to specific indications

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Market Drivers Influencing MAGNEVIST's Financial Trajectory

1. Advances in MRI Technology and Prescription Trends

• Expanding MRI Imaging: The global MRI market surpassed USD 6 billion in 2021, expected to grow at a CAGR of over 4% through 2028 ([3]).
• Use of Contrast Agents: Contrast-enhanced MRI accounts for approximately 20% of all MRI procedures, with a rising trend in neuroimaging and oncology ([4]).
• Impact: Increased utilization supports steady demand for contrast agents like MAGNEVIST.

2. Safety Concerns and Regulatory Environment

• Gadolinium Retention: Reports of gadolinium deposition in the brain and bones raised safety concerns, leading agencies such as the EMA and FDA to revisit approvals.
• Regulation Impact: EMA’s 2018 restriction on linear GBCAs prompted a shift towards macrocyclic agents; MAGNEVIST, an open-chain agent, faced scrutiny ([5]).
• Patient and Clinician Preferences: Growing preference for safer agents could result in decreased MAGNEVIST use, impacting revenues.

3. Competitive Landscape and Product Differentiation

• Emerging Macrocyclic Agents: Safer, more stable macrocyclic agents are increasingly preferred.
• Price Competition: Intense pricing pressure from generic and alternative products.
• Market Share Dynamics: MAGNEVIST’s share contracts as healthcare providers shift towards newer or safer options.

4. Patent and Manufacturing Lifecycle

• Patent Expiry: Limited patent lifespan—beyond exclusivity in some markets—leading to generic competition.
• Manufacturing Costs: Margins pressured by generic manufacturers reducing prices.

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Financial Trajectory: Historical Data and Future Outlook

Historical Revenue Performance

Year	Estimated Revenue (USD millions)	Notes
2018	65	Peak before safety concerns fully emerged
2019	58	Slight decline, market adjustments
2020	50	Pandemic effects, regulatory focus intensifies
2021	45	Continued decline in sales volumes

Note: Figures are approximations based on market reports and industry estimates.

Forecasting MAGNEVIST’s Financial Trajectory (2023-2028)

Parameter	Projection	Assumptions	Notes
Compound Annual Growth Rate (CAGR)	-3% to -5%	Regulatory tightening, safety concerns	Decline expected unless new formulations or indications are developed
Market Fragmentation	Increased	Increased competition	Leading to predominance of macrocyclic agents
Potential Revenue (2028)	USD 25-35 million	Market decline stabilizes	If marketed effectively for specific indications

Note: Strategic underpins include diversification, niche marketing, or formulation innovations.

Factors Likely to Affect Financial Outcomes

Factor	Impact	Mitigation Strategies
Safety concerns	Negative	R&D for safety improvements or new formulations
Regulatory restrictions	Negative	Engagement in policy advocacy and harmonization
Competition	Negative	Building niche indications or proprietary technologies
Technological innovation	Positive	Integration with advanced MRI protocols

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Comparison with Other GBCAs: Clinical and Market Considerations

Feature	MAGNEVIST (Gadopentetate Dimeglumine)	Gadovist (Gadobutrol)	Dotarem (Gadoterate Meglumine)	Gadavist (Gadobutrol)
Structure	Linear	Macrocyclic	Macrocyclic	Macrocyclic
Stability	Lower (linear)	Higher	Higher	Higher
Pregnancy Category	B	B	B	B
Regulatory restrictions	Elevated	Less	Less	Less
Pricing (Approximate)	Moderate	Higher	Moderate	Higher

The macrocyclic structure offers enhanced stability, favoring safety and market adoption.

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Strategic Opportunities and Challenges for MAGNEVIST

Opportunities

• Niche Indications: Focus on applications with limited alternatives, such as specific neuroimaging protocols.
• Innovative Delivery: Development of longer-lasting formulations or targeted delivery systems.
• Regional Growth: Expanding in emerging markets with less regulatory stringency.

Challenges

• Safety-driven Market Shift: Moving away from linear GBCAs.
• Pricing Pressure: Compression of margins due to generic competition.
• Regulatory Risks: Stringent policies and potential bans for linear agents.

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Key Market Trends and Predictions

Trend	Impact	Forecast (2023-2028)
Shift to Macrocyclic GBCAs	Decline in MAGNEVIST’s share	Accelerates decline
Regulatory Caution	Reduced use in certain markets	Market contraction
Clinical Preference for Safer Agents	Preference for macrocyclic agents	Market share loss
Technological MRI Advancements	Reduced dependence on contrast agents	Potential decline in contrast volume growth

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Conclusion

MAGNEVIST’s market position is under pressure from safety concerns, regulatory constraints, and competitive innovations. While its foundational role in MRI imaging ensures continued demand, the overall financial trajectory suggests a gradual decline, barring strategic adaptations like new indications or formulations. Stakeholders should monitor regulatory developments and explore niche markets or adjunct applications to sustain value.

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Key Takeaways

• The global MRI contrast agents market is expanding at around 4% CAGR, but MAGNEVIST faces a declining trajectory due to safety concerns linked to linear gadolinium agents.
• Regulatory agencies increasingly favor macrocyclic GBCAs, adversely affecting MAGNEVIST’s market share.
• Revenue estimates indicate a drop from approximately USD 65 million in 2018 to around USD 45 million in 2021, with projections favoring further declines.
• Competition and pricing pressures are intensified by generic entrants, compelling strategic shifts.
• Opportunities exist in niche applications, regional markets, and innovation, but macro-level trends favor safer, more stable agents.

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FAQs

1. What are the primary safety concerns impacting MAGNEVIST’s market?
Gadolinium retention in the brain and bones has raised safety alarms, prompting regulatory restrictions and a shift toward macrocyclic agents with higher stability.

2. How does MAGNEVIST compare to macrocyclic GBCAs in terms of stability?
MAGNEVIST, a linear agent, has lower kinetic and thermodynamic stability compared to macrocyclic agents like Gadavist and Dotarem, influencing regulatory and clinical preferences.

3. What regulatory changes could further affect MAGNEVIST’s market?
The EMA’s 2018 restrictions on linear GBCAs and potential FDA reevaluations could lead to market exits or usage limitations, further diminishing its market share.

4. Are there any clinical advantages of MAGNEVIST?
Its established safety profile in certain indications and longstanding clinical utility remain advantages, but these are increasingly outweighed by safety concerns associated with linear agents.

5. What strategic moves can manufacturers pursue to sustain MAGNEVIST’s revenues?
Innovation in formulations, targeting niche indications, and regional marketing strategies can help mitigate decline, alongside active engagement in safety profile improvements.

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References

1. MarketResearch.com. Global MRI contrast agents market analysis, 2022.
2. IQVIA. Global pharmaceutical market reports, 2022.
3. Grand View Research. MRI Market Size & Share, 2021-2028.
4. FierceBiotech. Trends in MRI contrast agent usage, 2021.
5. European Medicines Agency (EMA). Gadolinium-based contrast agents—Background and updates, 2018.