List of Excipients in Branded Drug CLARISCAN

Generic Drugs Containing CLARISCAN

Company	Ingredient	NDC	Excipient
GE Healthcare	gadoterate meglumine	0407-2943	TETRAXETAN
GE Healthcare	gadoterate meglumine	0407-2943	WATER

What are the Most Frequently-Used Excipients in CLARISCAN?

# Of NDCs	Excipient
1	TETRAXETAN
1	WATER

CLARISCAN Excipient Strategy and Commercial Opportunities

Last updated: August 23, 2026

Clariscan is a gadolinium-based magnetic resonance imaging contrast agent containing gadoterate meglumine, a macrocyclic gadolinium chelate. Its commercial formulation is intentionally simple: the active complex is supplied in aqueous solution with meglumine and Water for Injection. The main excipient opportunity is therefore not a new inactive ingredient. It is control of chelate stability, elemental impurities, container compatibility, sterile fill-finish, dosing formats, and cost-efficient regional supply.

Clariscan is marketed by GE HealthCare. In the United States, the product is supplied as a preservative-free, single-dose injectable formulation at 0.5 mmol/mL. The formulation has limited room for conventional excipient differentiation because changes to pH, osmolality, ionic composition, or chelate-equilibrium conditions can affect safety, stability, and imaging performance.[1]

What is the Clariscan formulation?

Clariscan contains gadoterate meglumine, water, and excess meglumine associated with the salt form and formulation environment.

Attribute	Clariscan profile
Active pharmaceutical ingredient	Gadoterate meglumine
Gadolinium concentration	0.5 mmol/mL
Dosage form	Sterile aqueous injection
Route	Intravenous
Primary excipients	Meglumine and Water for Injection
Preservative	None in the U.S. single-dose presentation
pH	Approximately 6.5 to 8.0
Osmolality	Approximately 1,350 mOsm/kg
Primary use	Contrast enhancement in MRI
Manufacturer or marketer	GE HealthCare
U.S. regulatory pathway	505(b)(2) NDA product, not a biosimilar

The U.S. prescribing information identifies 279.32 mg of gadoterate meglumine per milliliter, equivalent to 0.5 mmol of gadoteric acid and 0.5 mmol of gadolinium per milliliter.[1] The European product information similarly describes a macrocyclic gadolinium complex formulated with meglumine and water for injections.[2]

Why is meglumine the central excipient?

Meglumine performs more than one formulation function. It forms the meglumine salt of gadoteric acid and supports aqueous solubility at the required concentration. It also helps establish the ionic and pH environment needed for a stable injectable solution.

For a generic or alternative-source product, the key issue is not simply matching the excipient list. The manufacturer must demonstrate that the final product has comparable:

• Gadolinium-chelate integrity
• Free gadolinium control
• pH and osmolality
• Assay and impurity profile
• Particulate burden
• Sterility and endotoxin performance
• Container-closure compatibility
• Stability through the labeled shelf life

A formulation that replaces meglumine with another counterion could be treated as a different salt or product composition. That change may affect regulatory comparability, manufacturing controls, and intellectual-property risk. A product using the same active complex and excipient system has a clearer path to pharmaceutical equivalence, subject to applicable FDA requirements.

What excipient strategy is most commercially attractive?

The strongest strategy is excipient minimization combined with process control. Clariscan already uses a narrow excipient platform, so commercial value is more likely to arise from supply reliability and manufacturing economics than from adding novel excipients.

1. Pharmaceutical-grade meglumine supply

Meglumine is a specialized pharmaceutical excipient with fewer qualified sources than common formulation materials such as sodium chloride or polysorbate 80. A supplier that can provide consistent low-metal, low-endotoxin meglumine with validated change-control procedures can compete on:

• Long-term supply contracts
• Regional dual sourcing
• Lower impurity variability
• Reduced batch-release testing
• Regulatory support for excipient master files
• Emergency inventory for contrast-media manufacturers

Metal contamination is commercially relevant because gadolinium products require tight control of elemental impurities and free gadolinium. The supply specification for meglumine should address trace metals, bioburden, endotoxin, water content, and degradation products.

2. Low-metal Water for Injection systems

Water for Injection is not a differentiated excipient in itself, but water-system design can affect product quality. A contrast-agent manufacturer may value:

• Dedicated high-purity water loops
• Low-metal contact surfaces
• Continuous conductivity and total organic carbon monitoring
• Validated microbial control
• Reduced hold times before sterile filtration
• Regional fill-finish capacity

The commercial opportunity is strongest for contract development and manufacturing organizations that can handle high-volume sterile injectables while maintaining low particulate and elemental impurity levels.

3. Container-closure and delivery systems

Because Clariscan is administered intravenously and is commonly supplied in single-dose vials or prefilled presentations, packaging can create a more defensible commercial position than the excipient itself.

Potential offerings include:

• Low-extractable glass vials
• Polymer containers with validated gadolinium compatibility
• Ready-to-use syringes
• MRI workflow-oriented dose formats
• Barcoded containers linked to injector systems
• Packaging that reduces transfer steps and preparation time

The relevant technical evidence includes extractables and leachables, adsorption, visible and subvisible particles, stopper compatibility, silicone-oil behavior, and shelf-life performance.

What patents protect Clariscan and its excipient system?

The core macrocyclic gadolinium-chelate technology originated before Clariscan’s current commercial launch and has been associated with gadoterate products such as Dotarem and Clariscan. Fundamental composition patents for gadoterate meglumine are generally old relative to current product commercialization. The remaining IP value is more likely to reside in specific manufacturing processes, purification controls, formulations, containers, injector systems, and methods of use than in a broad patent on gadoterate meglumine itself.

A public regulatory label does not establish the complete patent estate. Patent ownership, term, enforceability, and claim scope require a jurisdiction-specific review of:

• U.S. and foreign patent databases
• Assignment records
• Orange Book listings
• Regulatory exclusivity records
• Litigation dockets
• Licensed technology disclosures
• Continuation and divisional applications

For U.S. commercial planning, the FDA Orange Book is the primary public source for listed patents and regulatory exclusivity associated with approved drug products.[3] A contrast agent’s absence or limited presence in the Orange Book would not eliminate risk from non-listed process, formulation, device, or trade-secret rights.

What is the Orange Book status of Clariscan?

Clariscan’s regulatory product is a prescription contrast agent approved under an NDA. The Orange Book must be checked by product name, NDA number, and active ingredient to determine current listed patents and exclusivity. FDA approval status and patent listing status are separate questions.

The practical implications are:

Issue	Commercial implication
NDA approval	Establishes the reference product for applicable abbreviated applications
Orange Book listing	Determines listed patent certifications and potential Paragraph IV litigation
Patent expiry	Does not by itself establish generic launch freedom
Regulatory exclusivity	Can delay an abbreviated application independently of patent term
Method-of-use patents	May affect labeling, carve-outs, or litigation
Device or packaging rights	May remain outside the Orange Book

Clariscan is a small-molecule chelated contrast agent, not a biologic. A competing product would generally pursue an abbreviated generic pathway rather than a biosimilar pathway. The regulatory analysis must still account for chemistry, manufacturing, and controls differences that may be more consequential than the active ingredient identity.

When does Clariscan lose exclusivity?

Clariscan does not have a single global loss-of-exclusivity date. Patent expiry and regulatory exclusivity differ by country and by patent family. The product also sits within a broader gadoterate market that includes Dotarem and other gadolinium-based contrast agents.

The relevant timeline is:

Event	Strategic significance
Original gadoterate technology	Limits the likelihood of durable broad composition-patent protection today
Clariscan approval	Establishes product-specific regulatory status
Listed U.S. patents, if any	Can trigger Paragraph IV certification and litigation
Regulatory exclusivity expiry	Determines when an abbreviated applicant can receive approval
Manufacturing or formulation patents	May delay or shape launch even after regulatory exclusivity ends
Product-specific supply contracts	Can affect practical market entry without blocking legal entry

Generic entry risk is therefore likely to be driven by manufacturing capability, regulatory execution, hospital contracting, and injector compatibility rather than by a single blocking excipient patent.

What formulation patents could protect a Clariscan competitor?

The most commercially relevant claim categories are narrower than a broad gadoterate composition claim.

Chelate stabilization

Claims may focus on pH ranges, free-ligand levels, residual metal limits, degradation products, or manufacturing conditions that improve shelf life. These claims are difficult to assess from the ingredient list alone because the protection may reside in process parameters.

Sterile injectable composition

Potential claim elements include:

• Gadoterate concentration
• Meglumine concentration
• Defined pH range
• Osmolality range
• Low free-gadolinium specification
• Specific impurity thresholds
• Preservative-free presentation
• Stability after terminal sterilization or sterile filtration

Container and injector systems

Packaging claims may cover vial materials, prefilled syringes, automated injectors, dose recognition, or protocols that reduce dosing errors. These rights can have commercial value even when the injectable formulation is no longer strongly protected.

Manufacturing and purification

Manufacturing claims can address complexation order, reaction temperature, removal of uncomplexed gadolinium, filtration, crystallization, or isolation of the gadoterate salt. Trade secrets may be more important than issued patents in this area.

Which companies compete with Clariscan?

Clariscan competes within the gadolinium-based contrast-agent market rather than in a standalone product category.

Product	Active contrast agent	Strategic comparison
Clariscan	Gadoterate meglumine	Macrocyclic, ionic, 0.5 mmol/mL
Dotarem	Gadoterate meglumine	Same active contrast-agent class; marketed by Guerbet
Gadavist/Gadovist	Gadobutrol	Macrocyclic, nonionic, higher gadolinium concentration
ProHance	Gadoteridol	Macrocyclic, nonionic
MultiHance	Gadobenate dimeglumine	Linear, ionic, hepatobiliary properties
Omniscan	Gadodiamide	Linear, nonionic; declining strategic relevance in many markets

Macrocyclic agents are generally positioned around kinetic stability and reduced dissociation relative to linear agents. Commercial differentiation also depends on price, hospital formulary contracts, MRI injector integration, supply reliability, and local procurement rules.[4]

What licensing deals affect Clariscan?

Public regulatory and product information identifies the commercial product and its sponsor or marketer but does not, by itself, disclose the full economic terms of any underlying licensing, manufacturing, or technology agreements. Licensing analysis should distinguish among:

• Active-ingredient technology rights
• Regional commercialization rights
• Manufacturing licenses
• Device or injector arrangements
• Contract manufacturing
• Distribution agreements

The presence of a branded product does not prove that the marketer owns every patent or manufacturing right connected to the active agent. This distinction matters for freedom-to-operate analysis and for evaluating a potential generic supplier.

What commercial opportunities exist in Clariscan excipients?

The most credible opportunities are adjacent to the formulation rather than based on novel excipient substitution.

High-potential opportunities

1. Qualified meglumine supply with low elemental impurities.
2. Regional sterile fill-finish for single-dose contrast media.
3. Ready-to-use prefilled syringe formats.
4. Low-extractables container systems.
5. Automated injector compatibility and barcode integration.
6. Analytical testing for free gadolinium and chelate degradation.
7. Dual-source manufacturing platforms for hospital and government tenders.
8. Lower-cost presentations for emerging markets.

Lower-potential opportunities

Novel buffers, surfactants, preservatives, or viscosity modifiers are less attractive because they could alter the safety profile, comparability package, and regulatory pathway. The existing formulation is already relatively concentrated and operationally simple.

How strong is the Clariscan patent estate?

The patent estate is likely strongest around implementation rather than the basic gadoterate meglumine concept. Commercial risk should be ranked as follows:

IP category	Relative risk
Broad active-ingredient composition	Low to moderate, given age of the technology
Specific formulation claims	Moderate
Manufacturing and purification	Moderate to high
Container and injector systems	Moderate
Trade secrets and process know-how	High practical relevance
Method-of-use claims	Variable by jurisdiction and indication
Regulatory exclusivity	Product- and country-specific

This profile favors companies that can design around formulation and process claims while matching the reference product’s critical quality attributes.

Key Takeaways

• Clariscan contains gadoterate meglumine in a simple, preservative-free aqueous formulation.
• Meglumine is the principal strategic excipient because it supports salt formation, solubility, and formulation control.
• The best supplier opportunities are pharmaceutical-grade meglumine, low-metal manufacturing systems, sterile fill-finish, and container-closure platforms.
• Clariscan is a small-molecule contrast agent, so generic competition is more relevant than biosimilar competition.
• Fundamental gadoterate technology is mature; current IP risk is more likely to involve manufacturing, purification, formulation ranges, packaging, injectors, and trade secrets.
• No single global patent-expiry date governs Clariscan. U.S. entry analysis requires review of FDA exclusivity, Orange Book listings, patent families, and litigation records.
• Commercial differentiation will depend heavily on price, supply continuity, injector integration, and hospital procurement.

FAQs

Is meglumine replaceable in a generic Clariscan formulation?

A substitute counterion or buffer could create a different formulation and complicate pharmaceutical equivalence. Meglumine is the lowest-risk starting point for matching the reference product’s salt and solution characteristics.

Does Clariscan require a biosimilar application?

No. Clariscan contains a defined small-molecule gadolinium chelate and is not a biologic. A competing product would generally use an applicable generic or abbreviated drug pathway.

Can a company commercialize gadoterate meglumine after core patents expire?

Potentially, but core patent expiry does not resolve process patents, formulation claims, device rights, regulatory exclusivity, or trade-secret constraints. A full freedom-to-operate review remains necessary for each jurisdiction.

Are preservatives commercially attractive for Clariscan alternatives?

Usually not. The established product is a single-dose injectable. Adding preservatives could create new toxicology, compatibility, labeling, and regulatory issues without a clear clinical advantage.

Which excipient has the greatest supply-chain importance?

Meglumine has greater strategic importance than Water for Injection because it is a specialized pharmaceutical material directly linked to the salt form and formulation performance.

References

1. U.S. Food and Drug Administration. (2019). Clariscan (gadoterate meglumine) injection: Prescribing information. https://www.accessdata.fda.gov
2. European Medicines Agency. (2024). Clariscan: European public assessment report and product information. https://www.ema.europa.eu
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
4. U.S. Food and Drug Administration. (2018). Gadolinium-based contrast agents: Drug safety communication. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fda-drug-safety-communication-fda-evaluates-risk-brain-deposits-after-repeated-use-gadolinium-based