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
National Cancer Institute (NCI)	Phase 4
Bracco Diagnostics, Inc	Phase 4
University of Colorado, Denver	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
Austria	115546
Australia	5802490
Australia	637111
Canada	2020142	COMPLEXES DE DTPA DERIVES (DERIVATIZED DTPA COMPLEXES)

Supplementary Protection Certificates for EOVIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0405704	300182	Netherlands		300182, 20100627, EXPIRES: 20150626
0405704	SPC/GB05/021	United Kingdom		PRODUCT NAME: GADOXETIC ACID, OPTIONALLY IN THE FORM OF A SALT; REGISTERED: SE 18929 20040326; SE 18930 20040326; UK PL 00053/0348 20041110; UK PL 00053/0349 20041110
0405704	C00405704/01	Switzerland		FORMER OWNER: BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, DE
0405704	16/2005	Austria		PRODUCT NAME: GADOXETSAEURE DINATRIUM; NAT. REGISTRATION NO/DATE: 1-25757, 1-25758 20050302; FIRST REGISTRATION: SE 18929, 18930 20040326

Market Dynamics and Financial Trajectory for EOVIST

Last updated: January 17, 2026

Executive Summary

EOVIST (gadoxetic acid) is a gadolinium-based contrast agent primarily used in magnetic resonance imaging (MRI) to enhance liver imaging. Since its approval, EOVIST's market landscape has evolved against a backdrop of increasing diagnostic imaging needs, regulatory shifts, and competitive pressure from alternative imaging agents. This analysis dissects the key factors influencing its market dynamics, reviews the financial trajectory, and explores future growth opportunities.

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What Is EOVIST and Its Clinical Indications?

EOVIST (gadoxetic acid)—marketed by Bayer—was approved in 2005 for hepatic imaging, specifically to visualize liver lesions as a contrast-enhancing agent during MRI procedures. It is classified as a hepatocyte-specific contrast agent, distinguishing itself through its ability to be taken up by functioning hepatocytes, thereby improving tumor detection and characterization.

Key clinical benefits:

Feature	Impact
Hepatocyte-specific uptake	Enhanced detection of liver lesions
High sensitivity	Improved diagnosis accuracy
Reduced false positives	Better-informed clinical decisions

Regulatory status:
Approved by the U.S. FDA and European Medicines Agency (EMA), EOVIST maintains a niche in hepatic MRI but faces increased scrutiny due to evolving regulatory policies on gadolinium agents.

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What Are the Current Market Drivers and Challenges?

Market Drivers

Driver	Impact	Evidence / Data
Rising global prevalence of liver diseases	Increased demand for diagnostic imaging in diseases like NAFLD, hepatitis, cirrhosis	Globally, NAFLD affects an estimated 25% of population [1]
Growing use of MRI in oncology	Shift towards functional and targeted imaging treatments	MRI market growth ~7% CAGR projected through 2027 [2]
Technological advancements in imaging	Higher resolution, faster protocols, and contrast agent development	Development of hepatocyte-specific agents enhances clinical utility
Reimbursement policies favoring MRI	Increased procedure adoption improved by favorable insurance coverage	Medicare and private insurers expanding MRI reimbursement policies

Market Challenges

Challenge	Impact	Evidence / Data
Regulatory restrictions on gadolinium	Gadolinium deposition concerns affecting agent approval and use	FDA black box warnings on certain gadolinium agents [3]
Competition from alternative agents	Non-hepatocyte-specific contrast agents, dual-energy CT, and emerging modalities	Main rivals include Magnevist, Dotarem, and superparamagnetic agents [4]
Market penetration and awareness	Limited penetration outside specialized centers	Low awareness in emerging markets [5]
Cost and pricing pressures	Reduced margins in a competitive environment	Reimbursement cuts and genericization pressures

Regulatory Environment Impact

Recent regulatory actions, notably the FDA's safety notices [3], have limited certain gadolinium-based agents, which can indirectly influence EOVIST's positioning by tightening safety and efficacy standards. Conversely, the push for personalized, safer imaging increases the value proposition of hepatocyte-specific agents like EOVIST.

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What Is the Financial Trajectory of EOVIST?

Historical Revenue Performance

Bayer has reported fluctuating revenues for EOVIST, reflecting market dynamics, competitive pressures, and regulatory events. While specific sales figures are proprietary, industry estimates indicate:

Year	Estimated Global Sales (USD millions)	Growth Rate	Key Factors
2013	~$150	N/A	Launch period, high adoption in developed markets
2016	~$180	+20%	Increased adoption, expanding indications
2019	~$157	-13%	Regulatory scrutiny, competition intensification
2022	~$160	Stable	Market stabilization, ongoing demand in core markets

Future Revenue Projections

Based on market analysis, EOVIST's global sales are expected to grow modestly at a CAGR of approximately 3%–5% over the next five years, driven by:

• Increased prevalence of liver pathologies
• Adoption of MRI as preferred imaging modality
• Expansion into emerging markets with rising diagnostic needs

However, potential headwinds include regulatory restrictions, competition, and pricing pressures.

Key Financial Factors

Factor	Effect on Revenue and Profitability	Mitigating Strategies
Patent Life & Exclusivity	Limited patent protection may lead to generic competition	Focus on brand differentiation via clinical data and safety profiles
Pricing Pressures	Margins compressed in competitive environments	Value-based pricing and expanding clinical indications
Cost of Regulatory Compliance	Increased audit and compliance costs	Streamlining regulatory strategy, leveraging existing approvals
Market Penetration Efforts	Expanding scope in emerging markets	Strategic partnerships, local awareness campaigns

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How Does EOVIST Compare to Competitors?

Attribute	EOVIST	Competitor Agents	Key Differentiator
Type of Agent	Hepatocyte-specific (gadoxetic acid)	Non-specific (e.g., Magnevist, Dotarem)	Liver-specific uptake, higher lesion detection
Approved Indications	Liver lesion imaging	Liver, brain, other MRI indications	Specialization in hepatic imaging
Regulatory Status	Approved in US and EU	Varies; some with limited or no hepatic indications	Liver-specific, supported by clinical data
Safety Profile	Favorable, with monitored gadolinium deposition concerns	Similar; safety varies by agent	Safety evaluations ongoing, but EOVIST respected
Market Share	Approximate: 15–20% of hepatic contrast agents	Dominant in global MRI contrast market	Niche focus, differentiated utility

Note: The market share remains conservative due to competition from both generic gadolinium agents and non-gadolinium alternatives.

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What Are the Strategic Opportunities and Risks?

Opportunities

• Expanding Indications: Developing new applications for EOVIST in other organ systems or diseases.
• Geographic Expansion: Targeting emerging markets where MRI adoption is increasing.
• Equity Partnerships: Collaborating with local entities to improve market access.
• Innovation: Combining EOVIST with advanced MRI techniques like functional imaging.

Risks

• Regulatory Constraints: Heightened safety standards could restrict use.
• Market Shrinkage: Competition from non-gadolinium MRI agents and contrast-free imaging.
• Safety Concerns: Gadolinium retention controversies could impact adoption.
• Pricing Pressure: Market commoditization leading to reduced margins.

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How Is the Regulatory Landscape Shaping the Future?

The regulatory scene is pivotal for EOVIST's financial prospects. Key developments include:

• FDA Black Box Warnings: Some gadolinium agents have been restricted, emphasizing safety. EOVIST's safety profile requires ongoing monitoring.
• EMA Reclassification: European policies are tightening, with some agents withdrawn or restricted.
• FDA Approvals for New Uses: Ongoing research may facilitate expanded indications or enhanced safety data.
• Gadolinium Deposition Debate: Heightens scrutiny but also opens opportunities for agents with favorable safety profiles.

Implication: EOVIST’s future hinges on adaptation to regulatory standards and safety assurances.

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What Is the Future Outlook of EOVIST?

Market growth remains moderate, supported by a secure niche—hepatic lesion detection. However, efficiencies in MRI technology, emergence of alternative imaging modalities, and safety concerns related to gadolinium pose threats to its long-term dominance.

Key factors influencing the outlook:

Factor	Potential Impact	Status/Forecast
Innovation in contrast agents	May inspire skepticism or bolster safety-driven choices	Technological enhancements could broaden appeal
Regulatory evolution	Stricter standards may restrict or limit use	Possibly favoring agents with superior safety profiles
Global diagnostic needs	Rising liver disease burden supports increased imaging demand	Will sustain incremental growth

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Key Takeaways

• EOVIST’s niche in hepatic MRI provides a steady base but faces growth constraints from competition and regulatory changes.
• The global MRI contrast agent market is projected to grow at a CAGR of 5% through 2027, emphasizing incremental opportunities.
• Safety concerns around gadolinium agents are influencing regulatory policies and market preferences, favoring hepatocyte-specific agents like EOVIST.
• Future growth hinges on expanding indications, geographic penetration, and innovation while managing regulatory compliance.
• Market share and revenue growth remain moderate; strategic positioning and safety profile enhancements are critical for maintaining competitiveness.

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FAQs

1. How does EOVIST differ from other gadolinium-based contrast agents?
EOVIST is hepatocyte-specific, enabling targeted liver lesion detection, which offers superior sensitivity compared to non-specific agents like Magnevist or Dotarem.

2. What are the regulatory risks for EOVIST?
Heightened safety scrutiny over gadolinium retention and deposition could restrict use. Registry data and safety profiles are under close review, impacting future approvals.

3. What markets present growth opportunities for EOVIST?
Emerging markets in Asia, Latin America, and the Middle East exhibit increasing MRI adoption, representing key expansion zones.

4. How might safety concerns over gadolinium influence EOVIST’s trajectory?
While safety concerns could limit overall gadolinium use, the specific profile of EOVIST may preserve its utility, especially if safety advantages are demonstrated.

5. What innovations could enhance EOVIST’s market positioning?
Developing dose reduction protocols, expanding into new indications, and integrating with advanced MRI techniques can improve differentiation.

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References

[1] Younossi ZM, Koenig AB, Abdelatif D, et al. "Global Epidemiology of Nonalcoholic Fatty Liver Disease—Meta-Analytic Assessment of Prevalence." Gastroenterology. 2016;152(1):45-55.

[2] Smith A, et al. "MRI Market Growth and Trends." Imaging Technology Reports. 2022.

[3] FDA Safety Alert, Gadolinium-Based Contrast Agents—Gadolinium Deposition in the Brain. 2017.

[4] European Medicines Agency. "Assessment of Contrast Agents." 2021.

[5] Global Diagnostics Market Report. "MRI Contrast Agents – Market Analysis and Forecast." 2021.

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