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
Paul Kim	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	5,560,903
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	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	021037-001	Mar 10, 2000	4,957,939
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	021037-001	Mar 10, 2000	4,647,447
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	019596-001	Jun 2, 1988	5,362,475

International Patents for MAGNEVIST

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

Country	Patent Number	Title	Estimated Expiration
Italy	1213128	MEZZI DIAGNOSTICI PER L'IMPIEGO NEL LA DIAGNOSTICA A RISONANZA MAGNETICA NUCLEARE,A RAGGI ROENTGEN O AD ULTRASUONI
Ireland	890169
Belgium	898708
Ireland	56857	PHYSIOLOGICALLY TOLERABLE METAL COMPLEX SALTS FOR USE IN NMR DIAGNOSIS
Canada	1240679	SELS COMPLEXES PARAMAGNETIQUES, PROCEDE DE PREPARATION ET UTILISATION DANS LES DIAGNOSTICS PAR RMN (PARAMAGNETIC COMPLEX SALTS, THEIR PREPARATION, AND THEIR USE IN NMR-DIAGNOSTICS)
Japan	H0772162
Australia	607456

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: July 28, 2025

Introduction

MAGNEVIST, a gadolinium-based contrast agent (GBCA), is used primarily for magnetic resonance imaging (MRI) diagnostics. Market dynamics surrounding MAGNEVIST are influenced by technological advancements in imaging, regulatory changes, safety concerns surrounding gadolinium retention, and competitive pressures. Its financial trajectory reflects evolving demand, regulatory landscapes, and patent considerations within the broad MRI contrast agent domain.

Pharmaceutical Profile and Market Position

MAGNEVIST, with the active ingredient gadopentetate dimeglumine, is marketed predominantly by Bayer Healthcare. It was among the earliest GBCAs introduced to the market, receiving widespread clinical adoption due to its high safety profile and diagnostic effectiveness.

As of 2023, MAGNEVIST holds a significant share of the global MRI contrast agent market, although competition from newer agents, including macrocyclic GBCAs such as Gadavist and Dotarem, has impacted its growth potential. The patent exclusivity of many early GBCAs has long expired, increasing generic competition and compressing profit margins.

Market Dynamics Influencing MAGNEVIST

1. Growing Demand for Advanced MRI Diagnostics

The expanding use of MRI across oncology, neurology, cardiology, and musculoskeletal imaging continues to drive demand for contrast agents. As MRI becomes more integral in early diagnosis and treatment monitoring, the need for gadolinium-based agents sustains market growth.

However, the emergence of newer, macrocyclic GBCAs offering improved chemical stability and lower risks of gadolinium deposition have begun to shift physician preference, especially in regions with heightened safety scrutiny.

2. Safety Concerns and Regulatory Impact

Gadolinium retention in brain tissues has raised safety concerns, prompting regulatory reviews across various jurisdictions. In 2017, the U.S. FDA issued warnings regarding gadolinium deposition, leading to increased clinician caution. Similar actions occurred in Europe and Japan.

These safety signals have prompted some healthcare providers to prefer macrocyclic agents over linear agents like MAGNEVIST, diminishing its relative market share. Regulatory authorities have also mandated revisions in prescribing information, which influence usage patterns.

3. Competition from Macrocyclic GBCAs

The transition from linear to macrocyclic contrast agents, characterized by higher kinetic stability, influences MAGNEVIST's market trajectory. Agents such as Gadavist (Bayer), Dotarem (Guerbet), and Vistradi (Bracco) offer a perceived safety advantage, responding to gadolinium deposition concerns.

Market analysts forecast a gradual decline in linear agent usage, including MAGNEVIST, as macrocyclic agents increasingly dominate the market. Nonetheless, MAGNEVIST retains relevance in emerging markets and specific indications.

4. Patent and Generic Market Entry

Most original patents for MAGNEVIST expired in the early 2000s, leading to multiple generic formulations. These generics have significantly reduced the drug’s price, impacting Bayer’s revenue from MAGNEVIST.

Generic penetration varies geographically, often faster in regions with less stringent regulatory processes. The resulting price competition constrains margins, compelling Bayer and other manufacturers to innovate or diversify their contrast agent portfolios.

5. Reimbursement and Healthcare Policy

Reimbursement policies influence MAGNEVIST’s financial trajectory. Countries with bundled healthcare systems or strict cost-effectiveness assessments tend to favor lower-cost generics and macrocyclic agents with better safety profiles, further pressuring MAGNEVIST’s market share.

Conversely, regions with high MRI utilization and less restrictive policies may sustain demand levels for linear agents like MAGNEVIST, especially in non-critical or routine imaging.

Financial Trajectory Analysis

Revenue Trends

Bayer’s global reporting for MAGNEVIST indicates declining revenues over the past decade, consistent with the patent expirations and the rise of alternative GBCAs. According to Bayer’s financial disclosures, contrast agent revenues have plateaued or decreased marginally, emphasizing the impact of market saturation and safety-driven preference shifts.

Profitability and Pricing

The entry of generics has compressed MAGNEVIST’s price points. Bayer’s strategic response involves cost-cutting, optimizing manufacturing efficiencies, and emphasizing niche or specialized applications where demand persists.

Growth Opportunities

Potential avenues for growth include developing new formulations with improved safety profiles, exploring indications beyond traditional imaging, or expanding into emerging markets where regulatory and safety concerns are less prominent. However, these are constrained by the inherent risks associated with gadolinium-based agents and the competitive landscape.

Future Outlook

Analysts project a slow to moderate decline trajectory for MAGNEVIST sales, paralleling the broader linear GBCA segment. The gradual shift in clinician preference toward macrocyclic agents and evolving safety guidelines may accelerate this decline.

Nevertheless, existing stockpiles, established clinical protocols, and regions with limited healthcare infrastructure may ensure residual demand for MAGNEVIST over the coming years.

Market and Financial Influences: Summary

Factor	Impact	Outlook
MRI utilization growth	Sustains baseline demand	Steady but moderate growth
Safety concerns and regulation	Dampens share, favors macrocyclic agents	Potential decline, especially in regulatory-heavy regions
Patent expiry & generics	Compresses margins	Continued price erosion
Competition from macrocyclic GBCAs	Reduces market share	Ongoing trend leaning toward new agents
Healthcare policy & reimbursement	Influences adoption decisions	Variable, region-specific

Key Takeaways

• MAGNEVIST remains relevant but faces structural headwinds due to safety concerns associated with linear gadolinium agents.
• The transition to macrocyclic agents is accelerating, reducing MAGNEVIST’s market share and profitability.
• Patent expirations and the proliferation of generic formulations have led to significant price competition, impacting revenues.
• Regulatory developments and safety warnings will continue to influence physician prescribing patterns, favoring newer agents.
• Strategic focus for Bayer involves developing safer, more stable contrast agents or expanding into niche imaging applications and emerging markets.

FAQs

Q1: Will MAGNEVIST regain market share due to safety concerns with other GBCAs?
A: Unlikely. While safety concerns have shifted some preference back, macrocyclic GBCAs are generally favored for their stability. MAGNEVIST’s market share will continue to decline relative to newer agents.

Q2: Are there ongoing patent protections for MAGNEVIST?
A: The original patents expired in the early 2000s, leading to widespread generic availability. No recent patents are actively protecting MAGNEVIST.

Q3: How do safety concerns about gadolinium deposition affect future sales?
A: Heightened safety awareness favors macrocyclic agents, which are less prone to gadolinium retention. This trend is likely to suppress future sales of linear agents like MAGNEVIST.

Q4: Which regions provide the most stable demand for MAGNEVIST?
A: Emerging markets with less regulatory oversight and clinical inertia may sustain demand, though overall declines are expected globally.

Q5: What strategic steps can Bayer take to maintain relevance?
A: Innovating safer contrast formulations, expanding indications, and targeting niche markets may help offset declines and sustain revenues.

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References

[1] Bayer. (2022). MAGNEVIST Product Information.
[2] FDA. (2017). Gadolinium-Based Contrast Agents – Safety and Usage Warnings.
[3] MarketWatch. (2023). Global MRI Contrast Agent Market Reports.
[4] European Medicines Agency. (2020). Safety Updates on Gadolinium Retention.
[5] IQVIA. (2023). Global Contrast Agent Market Data.