EOVIST Drug Patent Profile

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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. There is one drug master file entry for this compound. 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	5,798,092
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-002	Feb 4, 2013	6,039,931
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-001	Jul 3, 2008	6,039,931

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)
Czechoslovakia	9003174	DERIVATIVES OF DTPA COMPLEXES, PHARMACEUTICALS THAT CONTAIN THESE COMPOUNDS, THEIR APPLICATION AND METHOD OF THEIR PRODUCTION
Czech Republic	277926	DERIVATIVES OF DTPA COMPLEXES, PHARMACEUTICALS COMPRISING SAID COMPOUNDS, THEIR USE AND PROCESS FOR PREPARING THEREOF

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
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

Eovist (Gadoxetate Disodium) Market Dynamics and Financial Trajectory: Pricing, Share Shifts, and Patent/Competition Risks (US and EU)

Last updated: July 2, 2026

Eovist (gadoxetate disodium) is a contrast MRI agent used for liver imaging. Its revenue trajectory is driven by (1) hospital purchasing cycles for hepatobiliary MRI, (2) utilization patterns tied to HCC surveillance and staging, (3) competitive pressure from gadolinium contrast alternatives, and (4) exclusivity and supply stability in key markets. In the US, the product’s commercial outcome is shaped by competition for gadolinium-based liver imaging indications and by whether Eovist remains the default hepatobiliary MRI agent for formulary and procurement.

What drives Eovist (gadoxetate disodium) market demand and hospital adoption?

Demand drivers

• Hepatobiliary imaging use-case concentration: Eovist is used for liver lesion characterization and staging workflows, including hepatocellular carcinoma (HCC) pathways where imaging accuracy affects treatment decisions.
• Hospital protocol standardization: Adoption depends on radiology department protocols that define contrast selection for hepatobiliary phase imaging.
• Contrast agent substitution dynamics: Even when a product has a differentiated indication set, formulary committees often treat gadolinium agents as substitutable within a given imaging workflow, subject to tolerability and workflow fit.

Commercial lever points

• Imaging throughput and scheduling: Contrast selection impacts protocol duration and staff handling patterns. Purchasers emphasize reliability and supply continuity over incremental image-performance claims.
• Reimbursement alignment: Net pricing reflects Medicare and payer reimbursement specifics for MRI contrast use. Procurement teams weigh total cost per scan and administrative coverage policies.

Which clinical indications and imaging phases support Eovist spend?

Eovist is positioned for “hepatobiliary phase” imaging, commonly tied to:

• Liver lesion detection and characterization.
• HCC staging and treatment planning workflows.

(For label-backed claims and dosing, Eovist’s product labeling is the anchor source for indication scope and administration parameters, which affect formulary fit.)

How has Eovist’s revenue trajectory evolved since launch, and what does that imply for current financial outlook?

Executive read

• Eovist’s financial trajectory follows a typical specialty imaging profile: revenue is utilization-driven rather than dose-escalation-driven.
• Growth windows depend on radiology protocol adoption and competitive displacement risks within gadolinium contrast categories.
• A stable incumbent typically sees revenue flattening when competitors gain formulary share or when purchasing shifts to lower-cost alternatives.

What to track for financial trajectory modeling

1. US hospital contract outcomes (group purchasing organization and IDN-level contracts).
2. Dose conversion: contrast use per scan (MRI volume).
3. Net price vs. list price: rebates and distribution terms shape realized revenue.
4. Share of hepatobiliary-phase imaging: the operational metric that predicts future demand.

What pricing and contracting patterns matter most for Eovist profitability?

• Net-to-gross compression risk: Increased competition in gadolinium contrast tends to pressure realized pricing.
• Procurement switching frequency: Contrast agents can be switched at contract renewal cycles even when clinical staff have preferences, especially if performance equivalence is argued through internal radiology evaluations.
• Supply and service continuity: A supply disruption can temporarily increase urgency-buying, then cause contract renegotiations.

How strong is the patent estate for Eovist (gadoxetate disodium), and when does exclusivity end?

Exclusive rights structure (high level)

• Eovist is a small-molecule contrast agent with exclusivity historically anchored by composition and formulation-related patents plus regulatory exclusivities and lifecycle protections (where applicable).
• Market impact occurs when patent coverage expires and generic or authorized alternatives can launch.

Commercial significance

• Patent cliffs in imaging agents often translate into rapid share shifts because hospitals have procurement leverage and substitution is operationally feasible.

Which patent types typically block generic entry for contrast agents?

• Composition-of-matter patents (active ingredient salt/form).
• Formulation and concentration patents (stabilizers, ratios, delivery properties).
• Manufacturing method patents (process controls affecting stability or safety).
• Use patents (method-of-use) for specific imaging workflows or patient groups.

(The usable “blocking” patents for generics are usually those that protect the exact marketed presentation, not just broad contrast-agent use.)

What patents protect Eovist in the US and EU, and how many are in force?

A complete, accurate “how many patents” and “which exact patent numbers” mapping requires jurisdiction-level patent dossier review. Without that full dataset in the record, a precise count and list cannot be stated here without risking inaccuracies.

What is the Orange Book status of Eovist, and what generic entry risks exist?

Orange Book framework

• The Orange Book lists approved drug products and related patents for each NDA, including the patent numbers and expiration dates that can drive Paragraph IV challenges.

Generic entry risk logic for imaging agents

• If Orange Book-listed patents covering the marketed product have expired, generic entry risk rises sharply at the first legally available launch date.
• If key patents remain in force, generic challengers face delay through infringement litigation and potential settlement terms.

(A precise Orange Book status callout requires NDA-specific listing data for Eovist.)

Has Eovist faced Paragraph IV challenges or patent litigation in the US?

Paragraph IV risk materializes when generics certify against Orange Book-listed patents. Whether such challenges exist for Eovist depends on the NDA patent list and court filings. A litigation timeline with case numbers and outcomes cannot be accurately enumerated here without a verified case record in the provided source set.

How does Eovist compare with gadolinium contrast competitors for hepatobiliary imaging?

Competitive set logic Eovist competes against gadolinium-based MRI contrast agents used for liver imaging and lesion characterization. From a procurement perspective, key differentiators that influence adoption include:

• Hepatobiliary-phase imaging fit (label language and protocol alignment).
• Side-effect profile and administration workflow.
• Net price and contract positioning.

Which competitor classes typically displace Eovist in formularies?

• Gadolinium agents with broad liver imaging use language that allow radiology departments to meet workflow needs at lower cost.
• Authorized alternatives via distributors with strong hospital contracting relationships.

Financial consequence

• Displacement usually appears as margin compression (net price declines) and volume losses (reduced hepatobiliary-phase share) once switching begins at major accounts.

What settlement agreements or licensing deals could affect Eovist supply and pricing?

For imaging agents, settlements and licenses typically impact:

• Launch timing for competitors.
• Agreement scope (product form, indication carve-outs, or distribution channels).
• Royalty or supply arrangements that influence net pricing.

A verified account of specific Eovist-related settlements or licensing terms is not included in the available record for this response, so it cannot be stated.

What FDA regulatory milestones affect Eovist’s commercial trajectory?

FDA milestones affecting revenue typically include:

• Approval of new presentations or labeling updates.
• Changes in manufacturing sites and related quality outcomes.
• Postmarketing safety communications that change prescriber behavior.

A milestone-by-milestone impact analysis requires the Eovist FDA approval and supplement history with dates.

How does Eovist’s European market performance differ from the US?

EU drivers

• Pricing regulation and reimbursement mechanisms influence net revenue more directly than in the US.
• Tender systems in large hospital groups can rapidly reallocate share based on unit price.

Commercial implication

• Even without direct generic displacement, EU procurement can pressure realized pricing through tender-driven competition across gadolinium classes.

How do supply constraints and manufacturing risk influence Eovist financial results?

Imaging products are particularly sensitive to:

• Distribution continuity (hospital stock planning).
• Tight manufacturing schedules for sterile product supply.
• Batch release timelines affecting availability.

Financial impact pattern:

• Short supply periods can create temporary pricing lift but often lead to downstream contract resets and longer-term substitution.

Revenue exposure: which stakeholders and segments are most sensitive to Eovist demand shifts?

Most exposed

• Radiology services through hospital procurement.
• Specialty distributors and wholesalers tied to gadolinium contract volumes.
• Manufacturers with overlapping contrast portfolios that compete in tender cycles.

How to quantify exposure

• Track net sales at the geography and customer cohort level, then correlate with:
  • MRI utilization trends,
  • hospital tender cycles,
  • conversion of radiology protocols toward alternate hepatobiliary agents.

Key Takeaways

• Eovist demand is primarily utilization- and protocol-driven within hepatobiliary liver imaging workflows, not dose-driven.
• Financial trajectory depends on net pricing outcomes from hospital contracting and formulary share within gadolinium MRI competitors.
• Patent and Orange Book status are the primary legal levers that determine generic/authorized competition timing; without verified Eovist-specific listings and litigation records here, a precise exclusivity and challenge timeline cannot be asserted.
• The largest financial downside risks are formulary substitution at tender/contract renewals and net-to-gross compression as alternatives gain share.

FAQs

1. What factors determine hospital formulary switching for Eovist-style hepatobiliary MRI contrast?
2. How do tender-driven pricing mechanisms in the EU affect the net sales of MRI contrast agents?
3. What Orange Book patents are typically the most likely to delay generic entry for contrast products?
4. How should investors model imaging-agent revenue using net price, volume, and protocol share metrics?
5. What postmarketing safety or labeling changes most often impact prescribing for gadolinium contrast agents?

References

1. FDA. Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations. (Orange Book database entry for gadoxetate disodium/Eovist).
2. EMA. European public assessment reports (EPAR) and product information for gadoxetate disodium-containing MRI contrast agents.
3. US Prescribing Information for Eovist (gadoxetate disodium).