EOVIST Drug Patent Profile

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

Eovist is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in EOVIST is gadoxetate disodium. One supplier is listed for this compound. Additional details are available on the gadoxetate disodium profile page.

Summary for EOVIST

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	14
Drug Prices:	Drug price information for EOVIST
What excipients (inactive ingredients) are in EOVIST?	EOVIST excipients list
DailyMed Link:	EOVIST at DailyMed

See drug prices for EOVIST

Recent Clinical Trials for EOVIST

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

Sponsor	Phase
Bracco Diagnostics, Inc	Phase 4
University of Colorado, Denver	Phase 4
National Cancer Institute (NCI)	Phase 4

See all EOVIST clinical trials

Pharmacology for EOVIST

Drug Class	Gadolinium-based Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity

US Patents and Regulatory Information for EOVIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-001	Jul 3, 2008		RX	Yes	Yes
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-002	Feb 4, 2013		RX	Yes	No

Expired US Patents for EOVIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-001	Jul 3, 2008
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-002	Feb 4, 2013
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-001	Jul 3, 2008

International Patents for EOVIST

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0405704
Ireland	65676	Derivatized DTPA complexes pharmaceutical agents containing these compounds their use and processes for their production
Germany	3922005

Supplementary Protection Certificates for EOVIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0405704	300182	Netherlands		300182, 20100627, EXPIRES: 20150626
0405704	C00405704/01	Switzerland		FORMER OWNER: BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, DE
0405704	C300182	Netherlands		PRODUCT: GADOXETINEZUUR, DESGEWENST IN DE VORM VAN EEN ZOUT, IN HET BIJZONDER HET NATRIUMZOUT. FIRST AUTHORIZATION NO/DATE: 1829 AND 18930, 20040326 (SE); NATIONAL AUTHORIZATION NO/DATE: RVG 31393 AND 31394, 20050113

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Eovist

Last updated: August 1, 2025

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Introduction

Eovist, known generically as gadoxetate disodium, is a specialized contrast agent used primarily in magnetic resonance imaging (MRI) to enhance the visualization of hepatic lesions. Market dynamics surrounding Eovist are shaped by evolving technological landscapes, regulatory frameworks, competitive forces, and shifting healthcare paradigms. Understanding its financial trajectory involves analyzing current market positioning, growth drivers, challenges, and future prospects within the global pharmaceutical and diagnostic imaging sectors.

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Market Overview and Product Significance

Eovist is classified as an environmentally sensitive contrast agent offering enhanced imaging of liver tissues. Approved initially in 2004 by the FDA, it has gained widespread acceptance in hepatobiliary imaging due to its superior specificity. The increasing global burden of liver diseases—such as hepatocellular carcinoma (HCC), cirrhosis, and metastases—propels demand for precise diagnostic tools like Eovist, positioning it as a critical asset in hepatic diagnostics.

The global MRI contrast agents market, estimated at approximately USD 2.8 billion in 2021, is expected to grow at a compounded annual growth rate (CAGR) of around 4-6% through the next decade. Eovist's share within this space is influenced by its unique clinical advantages, regulatory approvals, and commercialization strategies.

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Market Dynamics Influencing Eovist

1. Technological and Medical Advances

Emerging innovations in MRI technology improve image resolution, potentially reducing reliance on contrast agents. Yet, the particular diagnostic strength of Eovist in liver imaging ensures sustained relevance. Further, the development of targeted contrast agents and integration with artificial intelligence (AI) algorithms for image interpretation could augment its utility.

2. Regulatory Environment and Approvals

Regulatory agencies, particularly the US FDA and European Medicines Agency (EMA), maintain stringent standards governing safety and efficacy, impacting Eovist's market access. Notably, regulatory initiatives promoting better patient safety, such as the minimization of gadolinium deposition risks, influence formulation and usage protocols.

3. Competitive Landscape

Eovist faces competition from other hepatic MRI contrast agents like Gd-EOB-DTPA (gadoxetate disodium) marketed in some regions and from non-contrast imaging techniques. The entry of new formulations with improved safety profiles or cost advantages may challenge Eovist's market share. Major players, including Bayer (producer of Eovist), have invested in expanding indications and optimizing formulations to maintain competitiveness.

4. Healthcare Infrastructure and Adoption Patterns

Increased adoption in emerging markets hinges on healthcare infrastructure development, reimbursement policies, and clinician familiarity. Countries such as India and China are witnessing rapid growth in diagnostic imaging, augmenting Eovist’s market opportunities. Conversely, regional regulatory delays and healthcare access disparities may temper growth.

5. Economic and Reimbursement Factors

Reimbursement rates and pricing strategies significantly affect Eovist’s financial performance. Favorable coverage by payers encourages usage, while restrictive policies inhibit sales. The ongoing trend toward value-based pricing and cost-effectiveness assessments influences strategic pricing decisions.

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Financial Trajectory and Revenue Trends

Historical Performance

As a niche but vital agent, Eovist contributed to Bayer's (its primary manufacturer) diagnostic imaging revenues, with the segment registering approximately EUR 4 billion in 2021. While precise Eovist-specific revenues are proprietary, historically, its sales have demonstrated resilient growth aligned with the broader MRI contrast market, buoyed by increasing hepatic disease diagnoses.

Projected Growth Drivers

• Rising Incidence of Liver Diseases: The World Health Organization estimates that liver cirrhosis and HCC cause over 1 million deaths annually, intensifying demand for accurate diagnostic imaging.
• Expanding Healthcare Access: Acceleration of imaging infrastructure in Asia-Pacific and Latin America opens new markets.
• Regulatory Approvals for New Indications: Broader approved uses could unlock additional revenue streams.
• Strategic Collaborations and Licenses: Partnerships with regional distributors enhance market penetration.

Potential Challenges Impacting Revenue

• Regulatory Restrictions: Gadolinium deposition concerns have led to cautious use recommendations, possibly limiting Eovist's application in some regions.
• Competitive Displacements: Advancements in non-contrast MRI techniques may reduce contrast agent reliance.
• Market Saturation: Mature markets may exhibit slower growth, emphasizing the importance of emerging economies for revenue expansion.

Forecast

Analysts project that Eovist’s overall regional sales will grow at a CAGR of approximately 3-5% over the next five years, driven by demand in emerging markets and ongoing clinical validation. However, this growth is contingent on regulatory stability, safety profile improvements, and strategic market expansion.

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Market Challenges and Opportunities

Challenges

• Safety Concerns: Gadolinium retention issues have led to regulations restricting use, prompting manufacturers to develop safer agents.
• Competitive Innovation: Soon-to-be-launched agents with improved safety and diagnostic capabilities could threaten Eovist’s market dominance.
• Economic Constraints: Healthcare budget limitations in developing countries may restrict adoption rate.

Opportunities

• Expansion into Adjacent Indications: Investigations into Eovist’s usefulness in other organ imaging applications provide potential growth avenues.
• Technological Integration: Incorporating Eovist with advanced MRI techniques and AI enhances clinical utility.
• Clinical Evidence and Guidelines: Consensus statements endorsing Eovist strengthen market position and reimbursement prospects.

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Regulatory and Market Access Outlook

Continued regulatory engagement and post-market safety surveillance are essential. The evolving regulatory environment, especially surrounding gadolinium-based agents, demands agility. Combining robust clinical data with proactive stakeholder communication can secure market access and reinforce Eovist's financial trajectory.

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Key Takeaways

• Global hepatic disease prevalence drives consistent demand for Eovist, supporting its steady market presence.
• Technological advancements and healthcare infrastructure expansion in emerging markets present growth prospects.
• Regulatory challenges related to gadolinium safety profile may impact future use and sales.
• Market competition persists from both alternative agents and novel imaging modalities, necessitating strategic innovation.
• Collaborative efforts with regulatory bodies and continuous clinical validation are vital for sustaining revenue growth.

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FAQs

1. What are the main factors influencing Eovist’s market share?
Eovist’s market share is primarily affected by its clinical efficacy, regulatory approvals, safety profile, competition from newer contrast agents, and healthcare infrastructure development in target regions.

2. How do safety concerns about gadolinium agents impact Eovist’s sales?
Safety concerns, particularly gadolinium deposition, have led regulatory restrictions and cautious prescribing practices, which can limit Eovist’s usage and revenue, especially in markets emphasizing safety.

3. What strategies are Bayer implementing to sustain Eovist’s market position?
Bayer is investing in clinical research to expand indications, engaging in regulatory dialogue to ensure compliance, and fostering market expansion through partnerships and educational initiatives.

4. How will emerging markets influence future revenue for Eovist?
Rapid growth in healthcare infrastructure and awareness in regions like Asia-Pacific and Latin America are expected to contribute significantly to Eovist’s future sales.

5. What role does technological innovation play in Eovist's market outlook?
Advancements in MRI technology, AI integration, and potential development of safer contrast formulations are critical for maintaining Eovist’s relevance and expanding its clinical applications.

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References

[1] MarketsandMarkets. "MRI Contrast Agents Market," 2021.
[2] World Health Organization. "Global Liver Disease Statistics," 2022.
[3] Bayer AG. "Eovist Clinical Data and Regulatory Updates," 2022.
[4] FDA. "Regulatory Guidance on Gadolinium-based Contrast Agents," 2021.
[5] Global Data. "Diagnostic Imaging Market Outlook," 2022.