CLARISCAN Drug Patent Profile

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

Clariscan is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in CLARISCAN is gadoterate meglumine. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the gadoterate meglumine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Clariscan

A generic version of CLARISCAN was approved as gadoterate meglumine by HAINAN POLY on June 17^th, 2024.

Summary for CLARISCAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	460
Drug Prices:	Drug price information for CLARISCAN
DailyMed Link:	CLARISCAN at DailyMed

See drug prices for CLARISCAN

Pharmacology for CLARISCAN

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

US Patents and Regulatory Information for CLARISCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	CLARISCAN	gadoterate meglumine	SOLUTION;INTRAVENOUS	210016-005	Nov 24, 2020	AP	RX	No	No
Ge Healthcare	CLARISCAN	gadoterate meglumine	SOLUTION;INTRAVENOUS	210016-003	Nov 1, 2019	AP	RX	No	No
Ge Healthcare	CLARISCAN	gadoterate meglumine	SOLUTION;INTRAVENOUS	210016-001	Nov 1, 2019	AP	RX	No	No
Ge Healthcare	CLARISCAN	gadoterate meglumine	SOLUTION;INTRAVENOUS	210016-002	Nov 1, 2019	AP	RX	No	No
Ge Healthcare	CLARISCAN	gadoterate meglumine	SOLUTION;INTRAVENOUS	210016-004	Aug 4, 2020	AP	RX	No	No

Clariscan Market Dynamics, Financial Trajectory, Patents, and Competitive Outlook

Last updated: August 16, 2026

Clariscan is GE HealthCare’s brand of gadoterate meglumine, a macrocyclic gadolinium-based contrast agent used for magnetic resonance imaging. Its commercial profile is driven by recurring hospital demand, substitution among equivalent gadolinium agents, tender pricing, and MRI procedure volumes rather than by exclusivity-supported pricing.

GE HealthCare does not separately disclose Clariscan revenue. The product’s financial performance must therefore be assessed through GE HealthCare’s Imaging segment, market-share indicators, regulatory status, contracting dynamics, and the competitive position of gadoterate meglumine relative to Dotarem, Gadavist, ProHance, and generic or authorized-generic products.

What is Clariscan and who markets it?

Clariscan contains gadoterate meglumine, also known as gadoteric acid. It is a gadolinium-based contrast medium for intravenous use in MRI examinations of the central nervous system, head and neck, musculoskeletal system, and other anatomical regions where contrast enhancement is clinically indicated.

Item	Detail
Brand	Clariscan
Active ingredient	Gadoterate meglumine
Active moiety	Gadoteric acid
Drug class	Macrocyclic gadolinium-based contrast agent
Primary manufacturer and marketer	GE HealthCare
U.S. regulatory pathway	NDA approval based on an established active ingredient and reference product
U.S. approval	2017
Principal competitors	Dotarem, Gadavist, ProHance, generic gadolinium contrast agents
Main customers	Hospitals, imaging centers, radiology groups, government health systems
Administration	Intravenous injection
Key commercial driver	MRI procedure volume and institutional purchasing contracts

The product is positioned as a macrocyclic agent, a category generally favored for its greater kinetic stability compared with linear gadolinium agents. The clinical and regulatory market has increasingly focused on gadolinium retention and the selection of agents with favorable stability profiles. The FDA has required class-wide labeling concerning gadolinium retention, but it has not concluded that gadolinium retention in patients with normal renal function is directly associated with adverse health effects at approved doses (FDA, 2018).

How large is the Clariscan market?

Clariscan’s standalone market size is not publicly reported by GE HealthCare. The company reports Imaging revenue at the segment level and does not provide product-level sales for Clariscan.

The addressable market is the global MRI contrast-media market. Its growth is linked to:

• MRI scanner installations and utilization.
• Growth in oncology, neurology, cardiovascular, and musculoskeletal imaging.
• Replacement of older scanners with higher-throughput systems.
• Increased use of contrast-enhanced MRI in outpatient settings.
• Hospital procurement consolidation.
• Price competition between branded agents and lower-cost alternatives.

Clariscan competes in a mature market. Volume growth is generally more important than price growth because institutional buyers often treat gadolinium agents as interchangeable products within clinical and procurement protocols.

GE HealthCare financial context

GE HealthCare’s Imaging segment includes MRI systems, CT, molecular imaging, X-ray, ultrasound-related imaging activities, and associated services. Clariscan is economically important as a recurring consumables product attached to imaging workflows, but it is not large enough for GE HealthCare to report separately.

Financial indicator	Commercial relevance to Clariscan
GE HealthCare total revenue	Indicates the scale of the parent company but does not isolate Clariscan
Imaging segment revenue	Best disclosed proxy for the product’s operating environment
MRI system placements	Expands the installed base using contrast agents
Service and equipment contracts	Support recurring relationships with hospitals and imaging providers
Product-level Clariscan revenue	Not separately disclosed
Product-level gross margin	Not separately disclosed

GE HealthCare’s Imaging segment provides a distribution and account-management advantage because the company sells MRI systems, imaging software, services, and contrast media into overlapping hospital accounts. That integration can improve access to procurement committees, although contrast agents are typically purchased through separate tenders or pharmaceutical procurement arrangements.

What is Clariscan’s financial trajectory?

Clariscan’s financial trajectory is likely characterized by stable to modest volume growth, declining or flat realized pricing in competitive tenders, and relatively predictable recurring demand.

The product lacks the commercial profile of a high-growth specialty medicine. Its economics resemble a hospital-use injectable with:

1. Repeat procedure-linked demand.
2. Limited patient-level brand loyalty.
3. High sensitivity to formulary and tender decisions.
4. Competitive pressure from other macrocyclic agents.
5. Manufacturing and supply reliability as important purchasing criteria.

Revenue growth drivers

The strongest growth drivers are MRI procedure volumes and the expansion of contrast-enhanced imaging in emerging markets. GE HealthCare’s MRI equipment installed base can support cross-selling, particularly where hospitals prefer standardized supply arrangements.

Other potential drivers include:

• Broader use of MRI in oncology surveillance.
• Growth in outpatient diagnostic imaging.
• Higher MRI utilization in Asia-Pacific and Latin America.
• Replacement of linear gadolinium agents with macrocyclic products.
• Institutional preference for suppliers with global distribution capabilities.

Revenue pressure

Price pressure is the central constraint. Large hospital systems and group purchasing organizations can shift volume among gadoterate meglumine, gadobutrol, gadopentetate, and other products when clinical protocols permit substitution.

The major downside risks are:

• Generic or lower-priced gadolinium products.
• Hospital budget controls.
• Delayed MRI equipment purchases.
• Contrast-media shortages or manufacturing interruptions.
• Greater use of noncontrast MRI protocols.
• Contract losses to Guerbet, Bayer, Bracco, or regional suppliers.

Because Clariscan revenue is not disclosed, no reliable public estimate supports a product-specific compound annual growth rate, margin, or earnings contribution. GE HealthCare’s segment reporting is the appropriate financial reference point, not a standalone Clariscan income statement.

How does Clariscan compare with Dotarem, Gadavist, and ProHance?

Clariscan’s closest branded competitor is Dotarem, which contains the same active ingredient, gadoterate meglumine. Dotarem is marketed by Guerbet. The two products compete primarily on price, supply, contracting, service, and institutional familiarity rather than on a materially different active ingredient.

Product	Active ingredient	Molecular class	Main commercial position
Clariscan	Gadoterate meglumine	Macrocyclic	GE HealthCare imaging and contrast portfolio
Dotarem	Gadoterate meglumine	Macrocyclic	Guerbet’s established gadoterate franchise
Gadavist	Gadobutrol	Macrocyclic	Bayer’s high-concentration macrocyclic agent
ProHance	Gadoteridol	Macrocyclic	Bracco’s established MRI contrast product
MultiHance	Gadobenate dimeglumine	Linear ionic	Bracco product with hepatobiliary imaging utility
Magnevist and other legacy agents	Various linear agents	Linear	Mature products with reduced strategic momentum

Gadavist has a differentiated concentration and broad global commercial presence. Dotarem has the most direct ingredient-level competition with Clariscan. ProHance competes for the same institutional formularies while offering a different macrocyclic chelate.

What is the FDA regulatory status of Clariscan?

Clariscan was approved by the FDA in 2017 for intravenous use in adults and pediatric patients, including term neonates, for contrast enhancement during MRI of the central nervous system, head and neck, musculoskeletal system, and other indicated regions listed in the prescribing information (FDA, 2017).

The product’s regulatory position has several implications:

• It is an approved prescription injectable.
• It is not a biologic and therefore does not face biosimilar competition.
• Its commercial competition comes from other contrast agents and generic equivalents.
• Labeling is affected by FDA class-wide requirements concerning gadolinium retention.
• Safety and supply compliance are central to hospital purchasing.

What is the Orange Book status of Clariscan?

Clariscan is listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called the Orange Book, under its approved NDA framework. The Orange Book is relevant for identifying approved products, patent information submitted by sponsors, and generic-equivalence designations.

Clariscan’s commercial exclusivity is not comparable to that of a newly discovered chemical entity. Gadoterate meglumine had already been approved and marketed internationally before the Clariscan approval. The absence of new-chemical-entity exclusivity limits the ability of the product to sustain premium pricing through regulatory exclusivity alone.

A product-level assessment should distinguish:

• FDA approval of the Clariscan NDA.
• Any patents listed for the NDA.
• Patent status for the underlying gadoterate formulation or delivery system.
• Patent status in jurisdictions outside the United States.
• Regulatory exclusivity attached to a specific application or supplemental approval.

Publicly available information does not establish a material, long-dated Clariscan patent barrier comparable to the core patent estates of innovative oncology or biologic products.

What patents protect Clariscan?

The principal commercial protection for Clariscan is unlikely to come from a broad, unexpired composition-of-matter patent covering gadoterate meglumine. The active ingredient is an established contrast agent with a long development history.

Potential protection can instead arise from:

• Formulation composition.
• Concentration and excipient selection.
• Manufacturing processes.
• Container and closure systems.
• Stability improvements.
• Specific dosing or administration methods.
• Regional patents held by licensors or manufacturing partners.

These categories generally provide narrower protection than a new-molecule patent. They can delay or complicate competition in particular jurisdictions, but they do not necessarily prevent competing gadolinium agents from entering the same market.

Patent strength assessment

Patent category	Likely strategic value for Clariscan
Active-ingredient composition	Low, because the ingredient is established
Formulation patents	Moderate if claims are narrow and enforceable
Manufacturing patents	Moderate, particularly where process reproducibility is difficult
Method-of-use patents	Limited unless tied to a specific approved indication
Device or container patents	Low to moderate
Regulatory exclusivity	Limited compared with a new chemical entity
Global patent coverage	Variable by jurisdiction
Biosimilar protection	Not applicable

When does Clariscan lose exclusivity?

Clariscan does not have a single global exclusivity-loss date. Patent and regulatory protection vary by jurisdiction, filing, listed patent, and dosage or formulation claim.

The U.S. approval in 2017 did not create a long new-chemical-entity exclusivity period because gadoterate meglumine was already an established active ingredient. Any remaining commercial protection would depend mainly on application-specific patents, formulation claims, manufacturing know-how, and market access barriers.

For financial forecasting, the more relevant question is not a single cliff date but the pace of:

• Generic approval.
• Hospital formulary conversion.
• Tender repricing.
• Competing macrocyclic launches.
• Manufacturing scale-up by lower-cost suppliers.

Are there Paragraph IV challenges to Clariscan?

No material, publicly disclosed Paragraph IV litigation involving Clariscan is evident in the principal publicly available U.S. regulatory and litigation records reviewed for this analysis.

That does not mean the product is insulated from generic competition. A generic applicant can challenge patents through a Paragraph IV certification, seek approval after patent expiry, or avoid listed claims through a noninfringing formulation or labeling strategy. A Paragraph IV filing would become commercially significant if it were paired with an abbreviated new drug application, a litigation complaint, and a credible launch-at-risk strategy.

The practical risk is likely to emerge through ordinary generic competition and hospital tendering rather than through a high-value patent trial.

What manufacturing and intellectual-property barriers affect Clariscan?

Manufacturing is a more meaningful barrier than core composition patent protection.

Gadoterate meglumine requires controlled synthesis of the chelating ligand, complexation with gadolinium, purification, analytical testing, sterile filling, and compliance with injectable-drug manufacturing standards. The product must meet stringent requirements for:

• Chemical purity.
• Free gadolinium control.
• Sterility and endotoxin limits.
• Complex stability.
• Particulate matter.
• Container integrity.
• Consistency across production batches.

These requirements can limit the number of reliable suppliers. Hospitals may retain incumbent suppliers even after patent barriers weaken if the supplier has a strong quality record, dependable inventory, and established procurement contracts.

Manufacturing barriers support share retention but do not necessarily support premium pricing. Contrast media tend to become increasingly price-sensitive as competing suppliers demonstrate equivalent quality and regulatory compliance.

What patent litigation affects Clariscan?

There is no prominent, publicly disclosed patent litigation currently associated with Clariscan that materially changes its market outlook. The product’s principal risks are commercial rather than litigation-driven.

Relevant litigation risk would arise from:

• A generic challenge to listed formulation patents.
• Disputes over manufacturing-process patents.
• Contract or supply litigation involving hospitals or distributors.
• Product-liability claims associated with gadolinium retention or hypersensitivity.
• Patent disputes involving the active ingredient or competing contrast technologies.

The lack of a major public patent case reduces the probability of a sudden litigation-driven launch event. It does not remove the possibility of gradual price erosion.

Which companies are challenging Clariscan commercially?

Clariscan faces competition from companies with established radiology sales channels and broad contrast portfolios.

Company	Competing product or capability	Competitive effect
Guerbet	Dotarem	Direct ingredient-level competitor
Bayer	Gadavist	Strong macrocyclic brand and global hospital access
Bracco	ProHance and other contrast media	Broad radiology portfolio
Generic manufacturers	Various gadolinium agents	Price pressure and tender substitution
Regional suppliers	Local or national contrast products	Lower-cost procurement alternatives
In-house or protocol alternatives	Noncontrast MRI in selected indications	Reduces contrast volume in limited use cases

GE HealthCare’s advantage is its installed-base relationship with imaging departments. Its disadvantage is that hospitals often separate equipment purchasing from contrast procurement, preventing automatic conversion of MRI customers into Clariscan customers.

What generic launch risks exist for Clariscan?

Generic launch risk is moderate in volume terms and high in price terms if an approved competitor secures contracts with major hospital systems.

The most likely commercial scenario is gradual erosion rather than an immediate loss of the market. Buyers may retain multiple agents for supply continuity, patient-specific protocols, and physician preference. This creates room for branded products to maintain volume while accepting lower prices.

Generic launch scenarios

Scenario	Expected effect
No near-term generic entrant	Stable volume; continued tender pressure
One approved generic	Selective price reductions and account-level switching
Multiple generic entrants	Faster price erosion and lower branded share
Supply disruption at a competitor	Temporary Clariscan volume increase
Broad formulary conversion	Material volume loss in affected institutions

Is biosimilar competition relevant to Clariscan?

No. Clariscan is a chemical drug, not a biologic. Biosimilar approval pathways under the Public Health Service Act do not apply.

Competition would occur through abbreviated new drug applications, conventional generic approvals, branded therapeutic alternatives, and hospital procurement contracts. This distinction matters because there is no biosimilar interchangeability framework or biologic reference-product exclusivity strategy supporting Clariscan.

What licensing deals support Clariscan?

GE HealthCare’s global commercialization of Clariscan is supported by its own imaging and pharmaceutical distribution infrastructure. The product’s development and marketing history also reflects the broader use of licensed or acquired contrast-media technologies across the industry.

No major, separately disclosed licensing transaction appears to provide Clariscan with a long-term exclusivity advantage comparable to a strategic license for a novel drug platform. The commercial value of the product is therefore tied more closely to manufacturing, regulatory approvals, distribution, and account contracts than to a publicly disclosed royalty-bearing patent license.

What is the geographic coverage of Clariscan?

Clariscan has been marketed across multiple regions, subject to country-specific approvals, labeling, supply arrangements, and commercial rights. The United States, Europe, and other developed MRI markets provide the strongest infrastructure for macrocyclic contrast-agent adoption.

Geographic performance will differ according to:

• MRI installed base.
• Public versus private hospital procurement.
• Local generic penetration.
• Reimbursement for contrast-enhanced MRI.
• National tender structures.
• Regulatory treatment of gadolinium retention.
• Local manufacturing and import requirements.

Europe is particularly relevant because gadoterate meglumine has a long-established clinical and commercial history there. Emerging markets offer volume growth but generally impose greater price pressure and can have more fragmented distribution.

How strong is the Clariscan commercial and patent estate?

Clariscan has a moderate commercial position and a limited-to-moderate patent position.

Commercial strengths

• Macrocyclic product positioning.
• Established FDA approval.
• Integration with GE HealthCare’s imaging customer base.
• Recurring use tied to MRI procedures.
• Broad institutional applicability.
• Potential supply-chain advantages.

Commercial weaknesses

• Limited product-level differentiation from Dotarem.
• No separately disclosed premium pricing power.
• High institutional tender exposure.
• Competition from multiple macrocyclic agents.
• No biologic or new-chemical-entity exclusivity.
• Revenue concentration within a mature contrast-media category.

Investment interpretation

Clariscan is better viewed as a recurring, defensive consumables product within GE HealthCare’s Imaging portfolio than as a standalone growth asset. Its value comes from recurring demand, account access, and portfolio integration. The primary financial risk is price compression, not a sudden patent expiry.

Key Takeaways

• Clariscan is GE HealthCare’s gadoterate meglumine MRI contrast agent.
• Its closest product competitor is Dotarem, which contains the same active ingredient.
• GE HealthCare does not separately disclose Clariscan revenue or profit.
• The product’s financial trajectory depends on MRI procedure volumes, hospital tenders, and supply reliability.
• Clariscan has no biosimilar risk because it is a chemical drug.
• Its regulatory exclusivity is limited because gadoterate meglumine was an established active ingredient before the 2017 U.S. approval.
• Core composition patent protection is unlikely to provide a long-term barrier.
• Formulation, manufacturing, supply, and contracting advantages are more important than broad patent exclusivity.
• No major publicly disclosed Paragraph IV or patent litigation event currently defines the product’s outlook.
• Generic entry would most likely produce gradual price erosion rather than an immediate market collapse.

FAQs About Clariscan

Is Clariscan the same as Dotarem?

Yes. Both Clariscan and Dotarem contain gadoterate meglumine. They are competing branded products marketed by GE HealthCare and Guerbet, respectively.

Is Clariscan a macrocyclic gadolinium contrast agent?

Yes. Clariscan is a macrocyclic gadolinium-based contrast agent containing gadoterate meglumine.

Does Clariscan have biosimilar competition?

No. Biosimilars apply to biologic products. Clariscan is a chemically synthesized contrast agent and would face generic or therapeutic competition instead.

Does GE HealthCare report Clariscan sales separately?

No. GE HealthCare reports revenue by operating segment, including Imaging, but does not publicly provide a standalone Clariscan revenue line.

Is Clariscan exposed to gadolinium-retention regulation?

Yes. FDA labeling for gadolinium-based contrast agents addresses gadolinium retention. Clariscan’s macrocyclic structure is commercially relevant because macrocyclic agents are generally more kinetically stable than linear agents, although all gadolinium-based agents carry regulatory labeling requirements.

References

1. U.S. Food and Drug Administration. (2017). Clariscan (gadoterate meglumine) injection prescribing information.
2. U.S. Food and Drug Administration. (2018). FDA warns that gadolinium-based contrast agents are retained in the body; requires new class warnings.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
4. GE HealthCare Technologies Inc. (2024). Annual report for the fiscal year ended December 31, 2023.
5. Guerbet. (2024). Universal registration document and annual financial report.
6. National Library of Medicine. (2024). DailyMed: Clariscan, gadoterate meglumine injection.