MAGNEVIST Drug Patent Profile

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

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

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

International Patents for MAGNEVIST

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

Country	Patent Number	Title	Estimated Expiration
Denmark	170461
European Patent Office	0071564	PARAMAGNETIC COMPLEX SALTS, THEIR PREPARATION AND THEIR USE IN NMR DIAGNOSTICS
Netherlands	195071
Ireland	53639	PARAMAGNETIC COMPLEX SALTS, THEIR PREPARATION, AND THEIR USE IN NMR-DIAGNOSTICS
France	2539996	AGENT DE DIAGNOSTIC, PROCEDE POUR PREPARER CET AGENT, ET SELS COMPLEXES

Supplementary Protection Certificates for MAGNEVIST

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

Investment Scenario and Fundamentals Analysis for Magnevist

Last updated: February 20, 2026

What is Magnevist?

Magnevist is a gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI) to enhance image clarity. It is marketed globally, primarily by Bayer Healthcare. Approved for diagnostic use, Magnevist's active ingredient is gadopentetate dimeglumine.

Market Overview

Global MRI contrast agent market was valued at approximately USD 3.2 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 4-6% through 2028. Gadolinium-based agents represent a significant share, with Magnevist historically holding a notable position.

Competitive Landscape

Key competitors include:

• Bayer’s Magnevist
• GE Healthcare’s Omniscan
• Bracco’s MultiHance
• Guerbet’s Dotarem

Magnevist's market share has declined with the advent of macrocyclic GBCAs, deemed safer, and gamma-distribution of newer agents with better safety profiles.

Patent and Regulatory Considerations

As of 2023, Magnevist's primary patents expired in the U.S. and EU regions, leading to potential generic entry. Regulatory authorities, including the FDA and EMA, have implemented more stringent guidelines on gadolinium retention and safety, prompting formulation adjustments and label updates.

Investment Fundamentals

Revenue and Earnings

Prior to patent expiration, Magnevist generated annual revenues between USD 400-600 million (pre-2020). Market share erosion due to generics and safety shifts resulted in revenue declines, estimated at 15-20% annually post-2021.

Patent Status

The expiration of key patents opens pathways for generic manufacturers. Bayer has limited patent protection on Magnevist in the U.S., claimed to expire in 2024, with some formulations extending to 2025 elsewhere.

R&D and Portfolio Strategy

Bayer has shifted focus toward developing newer, macrocyclic GBCAs and alternative imaging agents. Investment in next-generation contrast agents with improved safety profiles predicates a strategic move away from Magnevist.

Regulatory Risks

Enhanced safety evaluations and recalls have increased regulatory scrutiny. Changes in labeling to address gadolinium retention risks may impact sales and marketing strategies.

Market Trends

The move to macrocyclic agents (e.g., Dotarem, ProHance) has reduced the appeal of linear agents like Magnevist. The industry is also evolving towards lower doses and safer chelates, affecting overall demand.

Financial Outlook

• Expected revenue decline due to patent expiry and market shift.
• R&D costs allocated toward next-gen agents reduce reinvestment in Magnevist.
• Competitive pressure from generics and newer agents limits pricing power.

Investment Risks

• Patent expiry accelerates generic penetration, reducing margins.
• Regulatory restrictions on safety may diminish product reputation.
• Market shift toward macrocyclic agents impacts demand.

Opportunities

• Potential for suffix or new formulations to extend patent life.
• Growth in emerging markets where brand recognition remains high.
• Mergers or collaborations aimed at expanding portfolio or accessing new technology.

Summary

Investing in Magnevist involves exposure to declining legacy revenues due to patent expiration, regulatory shifts, and market preferences favoring safer, macrocyclic agents. Yet, opportunities exist in emerging markets, generics, and potential reformulations. A cautious approach requires tracking patent timelines, regulatory updates, and competitive innovations.

Key Takeaways

• Revenue trajectory is declining due to patent expiration and market shifts to macrocyclic GBCAs.
• Patent status points to increased generic competition starting around 2024-2025.
• Market dynamics favor newer, safer contrast agents, limiting growth prospects for Magnevist.
• Regulatory risks related to gadolinium safety affect product positioning and sales.
• Strategic moves include R&D investment into next-generation agents and potential patent extensions.

FAQs

1. When do Magnevist patents expire?
   Patent protections in the U.S. are expected to expire in 2024, with some formulations extending into 2025 in other regions.

2. How does safety concern impact Magnevist sales?
   Gadolinium retention and safety issues have prompted regulatory review and label updates, reducing physician preference and sales.

3. Are there generic versions of Magnevist available?
   Yes, generic gadolinium contrast agents are entering markets post-patent expiry, intensifying price competition.

4. What are alternatives to Magnevist?
   Macrocyclic GBCAs like Dotarem and ProHance offer improved safety profiles, gaining market share.

5. Is there potential for Magnevist reformulation?
   Reformulation could extend patent life, but current trends favor newer agents, making such moves less prioritized.

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References

1. MarketsandMarkets. (2023). MRI contrast agents market analysis.
2. Bayer Healthcare. (2022). Magnevist product information.
3. U.S. Food and Drug Administration. (2023). Gadolinium-based contrast agents safety updates.
4. IQVIA. (2022). Global diagnostic imaging market trends.
5. European Medicines Agency. (2023). Gadolinium-containing contrast agents assessment.