GADOTERATE MEGLUMINE Drug Patent Profile

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

Gadoterate Meglumine is a drug marketed by Hainan Poly, Hengrui Pharma, and Viwit Pharm. and is included in three NDAs.

The generic ingredient in GADOTERATE MEGLUMINE 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 Gadoterate Meglumine

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

Summary for GADOTERATE MEGLUMINE

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	17
Patent Applications:	460
DailyMed Link:	GADOTERATE MEGLUMINE at DailyMed

Recent Clinical Trials for GADOTERATE MEGLUMINE

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

Sponsor	Phase
Guerbet	PHASE3
Bracco Imaging S.p.A.	PHASE3
Peter Caravan	PHASE2

See all GADOTERATE MEGLUMINE clinical trials

Pharmacology for GADOTERATE MEGLUMINE

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

US Patents and Regulatory Information for GADOTERATE MEGLUMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hainan Poly	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	218073-001	Jun 17, 2024	AP	RX	No	No
Hengrui Pharma	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	215304-002	Apr 11, 2022		DISCN	No	No
Hainan Poly	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	218073-004	Jun 17, 2024	AP	RX	No	No
Viwit Pharm	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	219286-002	Aug 10, 2026	AP	RX	No	No

Gadoterate Meglumine Market Dynamics, Competition, Exclusivity, and Financial Outlook

Last updated: September 8, 2026

Gadoterate meglumine is a macrocyclic, ionic gadolinium-based contrast agent marketed primarily as Dotarem by Guerbet. Its commercial position is supported by strong MRI utilization, preference for macrocyclic agents with lower gadolinium retention, broad regulatory approvals, and established hospital procurement. Its main constraints are generic injectable competition, tender pricing, high manufacturing and quality-control requirements, and limited product-level financial disclosure.

Dotarem no longer has meaningful U.S. market exclusivity based on new chemical entity protection. The commercial market is now driven by supply reliability, formulary placement, pricing, radiology guidelines, and international distribution rather than by core molecule patent protection.

What is gadoterate meglumine and how is it used?

Gadoterate meglumine is the gadolinium salt of gadoteric acid, a macrocyclic and ionic chelate used as an intravenous MRI contrast agent. It is supplied at a concentration of 0.5 mmol/mL and is administered for contrast-enhanced MRI examinations.

The product is used across multiple imaging categories:

• Brain and central nervous system MRI
• Spine imaging
• Head and neck imaging
• Breast MRI
• Musculoskeletal MRI
• Abdominal and pelvic MRI
• Cardiac and vascular imaging
• Pediatric MRI

In the United States, Dotarem is approved for intravenous use in adults and pediatric patients, including neonates, for central nervous system, head and neck, breast, musculoskeletal, abdominal and pelvic MRI, and cardiac and vascular MRI indications (U.S. Food and Drug Administration [FDA], 2023a).

Gadoterate is classified as a macrocyclic GBCA. Macrocyclic agents form more stable complexes with gadolinium than linear agents. The stability distinction has influenced prescribing and procurement decisions since regulatory agencies identified concerns related to gadolinium retention and nephrogenic systemic fibrosis.

How large is the gadoterate meglumine market?

The global gadoterate meglumine market is concentrated around Guerbet’s Dotarem franchise, with generic and regional products expanding competition. Public companies generally do not report gadoterate revenue as a separate line item, so market size estimates depend on prescription volume, hospital purchasing data, distributor information, and company disclosures.

The main demand drivers are:

1. Growth in MRI procedure volumes.
2. Replacement of older linear GBCAs with macrocyclic products.
3. Increased use of contrast-enhanced MRI in oncology, neurology and cardiovascular diagnosis.
4. Pediatric and repeat-imaging demand.
5. Hospital preference for established suppliers with dependable sterile-injectable capacity.

The market is less exposed to consumer pricing than many oral pharmaceuticals. Hospitals, imaging centers, group purchasing organizations and national tenders control a substantial portion of purchasing. That structure places pressure on net prices even when procedure volumes increase.

What is the financial exposure for Guerbet?

Gadoterate meglumine is strategically important to Guerbet, but Guerbet does not separately disclose Dotarem revenue in its consolidated public reporting. Guerbet reports revenue by geographic area and business category rather than by individual contrast agent (Guerbet, 2024).

The company’s broader financial trajectory depends on:

• Dotarem and other MRI contrast media
• X-ray contrast agents
• Interventional imaging products
• Contrast delivery systems
• Product mix between branded and tender-driven markets
• Foreign exchange movements
• Raw-material and manufacturing costs

Dotarem contributes recurring revenue because MRI contrast is consumed per procedure. It does not have the recurring refill characteristics of a chronic oral medicine, but utilization is linked to procedure volume and hospital capacity. Product sales are also sensitive to procurement cycles and shortages.

The absence of product-level reporting prevents a precise calculation of Dotarem’s revenue, margin or percentage contribution to Guerbet. The available financial evidence supports viewing Dotarem as a major franchise within Guerbet’s MRI portfolio rather than as a separately valued public asset.

Which companies compete with gadoterate meglumine?

Gadoterate competes primarily with other macrocyclic GBCAs and, to a lesser extent, with linear GBCAs that remain available in selected markets.

Product	Active agent	Principal company	Structural class	Competitive position
Dotarem	Gadoterate meglumine	Guerbet	Macrocyclic, ionic	Originator and leading gadoterate brand
Clariscan	Gadoterate meglumine	GE HealthCare	Macrocyclic, ionic	Direct branded competitor in several markets
Gadavist/Gadavist	Gadobutrol	Bayer	Macrocyclic, nonionic	Strong competing macrocyclic GBCA
ProHance	Gadoteridol	Bracco	Macrocyclic, nonionic	Established macrocyclic alternative
MultiHance	Gadobenate dimeglumine	Bracco	Linear, ionic	Older agent with selected indications
Eovist/Primovist	Gadoxetate disodium	Bayer	Linear, ionic	Hepatobiliary-specific competition
Magnevist and other legacy products	Gadopentetate dimeglumine and others	Multiple	Linear	Reduced use because of safety and retention concerns

Clariscan is chemically equivalent in active moiety to Dotarem but is marketed by a different manufacturer. Gadavist and ProHance compete at the class level through physician preference, radiology protocols, hospital contracts and international tenders.

How does gadoterate compare with other MRI contrast agents?

Gadoterate’s central commercial advantage is its macrocyclic structure and ionic charge. These characteristics provide high thermodynamic and kinetic stability compared with many linear agents.

Attribute	Gadoterate meglumine	Gadobutrol	Gadoteridol	Linear GBCAs
Macrocyclic	Yes	Yes	Yes	Usually no
Ionic	Yes	No	No	Varies
Standard concentration	0.5 mmol/mL	1.0 mmol/mL	0.5 mmol/mL	Varies
Gadolinium retention concern	Lower relative concern	Lower relative concern	Lower relative concern	Generally greater concern
Generic competition	Emerging and market-dependent	Market-dependent	Market-dependent	Mature in several products
Key procurement factor	Safety profile, supply, price	Dose efficiency, image quality, price	Established use, price	Lower cost and legacy availability

Gadoterate’s 0.5 mmol/mL concentration may require a larger administered volume than 1.0 mmol/mL gadobutrol for an equivalent gadolinium dose. This difference can affect logistics, vial selection and purchasing economics.

What is the FDA regulatory status of gadoterate meglumine?

The FDA approved Dotarem in 2013. The approval established gadoterate meglumine as a U.S. contrast agent for multiple MRI applications, including adult and pediatric use (FDA, 2013).

Key U.S. regulatory milestones include:

Event	Date
FDA approval of Dotarem	March 2013
U.S. launch	2013
Five-year new chemical entity exclusivity	Expired in 2018
Generic-market pathway	ANDA-based, subject to product-specific FDA approval
Current regulatory category	Injectable prescription drug

Gadoterate is a small-molecule drug, not a biologic. As a result, competitors pursue abbreviated new drug applications rather than biosimilar applications. A biosimilar risk analysis is therefore not applicable in the legal sense used for biologic medicines.

The regulatory burden remains substantial because the product is a sterile injectable with tight requirements for:

• Identity and assay
• Chelation efficiency
• Gadolinium content
• Osmolality and pH
• Endotoxin control
• Sterility assurance
• Particulate matter
• Container-closure integrity
• Stability and storage
• Extractables and leachables

What patents protect gadoterate meglumine?

The core gadoterate molecule and its underlying chelation technology were disclosed and patented well before the U.S. launch of Dotarem. Those early patent rights have expired or are no longer the principal barrier to entry.

The remaining intellectual-property value is more likely to reside in:

• Specific pharmaceutical compositions
• Manufacturing and purification processes
• Sterile injectable formulations
• Container and delivery configurations
• Dosing or administration methods
• Device combinations
• Regional process claims

For U.S. generic entry, the decisive question is the current Orange Book listing for the reference product and the scope of any unexpired listed patents. Orange Book patents can be challenged through Paragraph IV certifications, but the practical entry date also depends on FDA approval, patent litigation, a 30-month stay, settlement terms and commercial launch strategy (FDA, 2024a).

Core composition-of-matter protection is not the principal exclusivity issue for gadoterate meglumine. The competitive analysis is formulation- and manufacturing-oriented.

What is the Orange Book status of Dotarem?

Dotarem is listed by the FDA as a prescription gadoterate meglumine injection product. The Orange Book determines whether a generic applicant must address listed patents through a Paragraph III certification or a Paragraph IV certification.

The commercial implications are:

• An approved ANDA can enter after applicable exclusivity and patent barriers are cleared.
• A Paragraph IV challenge can trigger patent litigation.
• A generic approval does not guarantee immediate launch.
• Injectable manufacturing capacity can delay practical competition even after approval.
• A reference-product patent dispute may concern formulation or process claims rather than the gadoterate molecule itself.

Patent status can change through new listings, litigation outcomes, settlements and regulatory determinations. The relevant commercial metric is the number of approved and actively marketed competitors, not the historical number of patents issued on gadoteric acid.

When did gadoterate meglumine lose exclusivity?

Dotarem’s five-year U.S. new chemical entity exclusivity expired in 2018. That exclusivity period prohibited FDA approval of an ANDA or 505(b)(2) application relying on the product’s reference-drug status during the statutory period.

The expiration did not automatically create generic competition. A competitor still needed:

1. A technically acceptable ANDA.
2. Compliance with sterile-injectable manufacturing requirements.
3. Resolution of any listed patent claims.
4. FDA approval.
5. Commercial supply and distribution capability.

The practical loss of exclusivity therefore occurred in stages. Regulatory exclusivity ended in 2018, while market competition developed later as generic manufacturers completed development and FDA review.

Which companies are challenging the gadoterate meglumine franchise?

The competitive challenge comes from three groups.

Direct gadoterate competitors

GE HealthCare’s Clariscan is the principal branded product with the same active moiety. It competes through hospital contracts, international registrations, imaging-center relationships and geographic supply.

Generic manufacturers can offer gadoterate meglumine injection at lower net prices after approval. FDA Drugs@FDA and Orange Book records should be read together because approval status, patent certification and actual commercial launch are separate events (FDA, 2024a; FDA, 2024b).

Macrocyclic GBCA competitors

Bayer’s Gadavist and Bracco’s ProHance compete for the same MRI procedure volume. These products can displace gadoterate without relying on direct generic substitution because radiologists and hospitals often select among agents at the protocol or formulary level.

Procurement-driven competitors

Regional manufacturers and contract suppliers compete in markets where contrast agents are awarded through tenders. Price, delivery reliability, local registration and supply continuity can outweigh brand recognition.

What generic entry risks exist for Dotarem?

Generic entry risk is material but does not necessarily produce immediate or complete substitution.

Risk factor	Effect on Dotarem
Expired NCE exclusivity	Removes the main regulatory barrier
Generic ANDA approval	Creates direct price competition
Multiple approved suppliers	Increases tender and hospital pricing pressure
Limited sterile capacity	Can slow real-world substitution
Physician familiarity	Supports continued branded use
Formulary contracting	Can accelerate generic conversion
Supply shortages	Can benefit suppliers with available inventory
Macrocyclic class competition	Limits pricing power even without direct generic entry

The most likely launch pattern is a gradual erosion of branded share rather than an immediate collapse. Hospitals may retain Dotarem for protocol continuity, pediatric use, physician preference or supply assurance. Large institutional accounts and public tenders are more exposed to substitution than independent imaging centers with established clinical workflows.

What manufacturing and intellectual-property barriers remain?

Gadoterate meglumine has a lower technical barrier than a biologic, but it is not a simple commodity. Manufacturing requires controlled complexation of gadolinium with the macrocyclic ligand, removal of uncomplexed metal and impurities, validated sterile filling, and reliable quality testing.

The main barriers include:

• Consistent control of free gadolinium
• Reproducible chelation yield
• Sterile manufacturing capacity
• High-volume vial and syringe production
• Regulatory comparability
• Global quality-system compliance
• Specialized analytical methods
• Reliable supply of pharmaceutical-grade raw materials

Process patents can affect manufacturing economics even when composition patents have expired. Trade secrets and process know-how may be more commercially relevant than published patent claims.

What patent litigation and settlements affect gadoterate meglumine?

No major U.S. patent settlement has established a widely reported delayed-entry framework comparable with settlements involving high-revenue oral medicines. The principal legal risk is product-specific litigation arising from Orange Book-listed patents, Paragraph IV certifications or disputes over formulation and process claims.

A generic applicant that files a Paragraph IV certification may face:

• Patent infringement litigation
• A statutory 30-month stay in applicable circumstances
• Settlement negotiations
• A licensed or authorized-generic arrangement
• Delayed commercial launch despite FDA approval

Because gadoterate revenue is smaller than the revenue of leading chronic medicines, litigation economics may favor limited challenges, negotiated market entry or direct competition based on noninfringement and invalidity positions.

How strong is the gadoterate meglumine patent estate?

The patent estate is moderate to weak against direct molecule-based entry and stronger around selected manufacturing, formulation and delivery claims.

Patent category	Relative strength
Core gadoterate composition	Low, largely historical
Macrocyclic chelation concepts	Low to moderate, depending on claim scope
Injectable formulation	Moderate
Manufacturing and purification	Moderate
Device and packaging	Low to moderate
Method of use	Low to moderate
Regulatory exclusivity	Expired in the United States

The commercial franchise therefore depends more on brand, regulatory history, manufacturing reliability, clinical familiarity and contracting than on a durable composition-of-matter patent moat.

What is the outlook for gadoterate meglumine revenue?

The financial trajectory should be modeled as a mature branded injectable franchise with stable procedure-linked demand and gradual price erosion.

Base case

Revenue remains supported by MRI growth and continued preference for macrocyclic GBCAs. Dotarem retains meaningful share in markets where Guerbet has strong distribution and hospital relationships. Net pricing declines as generic and branded alternatives expand.

Downside case

Multiple generic suppliers achieve reliable supply, hospitals convert formularies to lower-cost products, and tender pricing falls sharply. Guerbet experiences volume and price erosion in the United States and major European markets.

Upside case

MRI procedure growth exceeds price erosion, gadoterate gains share from older linear agents, and supply constraints affect competing products. Dotarem maintains premium positioning through safety perception, clinical familiarity and dependable availability.

The most important financial variables are MRI procedure growth, generic penetration, net price per dose, tender renewal outcomes, geographic mix, production costs and Guerbet’s ability to bundle contrast media with delivery systems and broader imaging solutions.

How does gadoterate compare with competing MRI contrast agents financially?

Gadoterate has a mature franchise profile. Gadavist and ProHance compete through differentiated brand positions, while Clariscan creates direct same-molecule pressure. Linear agents face greater structural disadvantages in markets that prioritize macrocyclic products.

Commercial factor	Gadoterate meglumine	Gadobutrol	Gadoteridol	Linear agents
Brand maturity	Mature	Mature	Mature	Mature or declining
Direct generic pressure	Increasing	Market-dependent	Market-dependent	Often high
Safety-driven substitution opportunity	Strong versus older linear products	Strong	Strong	Weak
Price resilience	Moderate	Moderate	Moderate	Low to moderate
Manufacturing complexity	High	High	High	High
Hospital tender exposure	High	High	High	High

Key Takeaways

• Gadoterate meglumine is a mature macrocyclic GBCA marketed primarily as Dotarem by Guerbet.
• U.S. five-year new chemical entity exclusivity expired in 2018.
• The product is a small-molecule injectable, so generic competition applies rather than biosimilar competition.
• Core molecule protection is no longer the main barrier to entry.
• Formulation, manufacturing, sterility and process know-how remain relevant commercial defenses.
• Clariscan, Gadavist and ProHance are important competitive products.
• Generic entry is likely to pressure net pricing, especially in hospital tenders and large imaging networks.
• Guerbet does not publicly disclose Dotarem revenue separately, limiting product-level financial valuation.
• Long-term revenue depends more on MRI volume, formulary position, supply reliability and geographic execution than on patent exclusivity.

FAQs

Is gadoterate meglumine still patent-protected?

Historical patents covering the molecule and chelation technology are not the principal barrier to entry. Any current protection is more likely to involve formulation, manufacturing, process or delivery claims.

Is Dotarem a biologic or a generic drug?

Dotarem is a small-molecule gadolinium contrast agent. Competitors seek FDA approval through ANDAs or other small-molecule pathways, not through the biosimilar pathway.

Is gadoterate meglumine safer than linear gadolinium agents?

Macrocyclic gadoterate forms a more stable gadolinium complex than many linear agents. FDA labeling still requires warnings concerning renal impairment, nephrogenic systemic fibrosis and gadolinium retention (FDA, 2023a).

Can hospitals substitute a generic gadoterate product automatically?

Substitution depends on state law, hospital formulary rules, procurement contracts, FDA-rated equivalence and the specific product available. FDA approval alone does not determine operational substitution in every institution.

What is the largest commercial threat to Dotarem?

The largest threat is combined pressure from direct generic gadoterate products, Clariscan and competing macrocyclic agents in hospital tenders. Price competition is likely to intensify as more suppliers achieve reliable sterile-injectable capacity.

References

Guerbet. (2024). 2023 universal registration document and annual financial report. Guerbet.

U.S. Food and Drug Administration. (2013). Dotarem: Gadoterate meglumine injection prescribing information. FDA.

U.S. Food and Drug Administration. (2023a). Dotarem label. FDA.

U.S. Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

U.S. Food and Drug Administration. (2024b). Drugs@FDA: FDA-approved drugs database. FDA.

U.S. Food and Drug Administration. (2024c). Gadolinium-based contrast agents: Drug safety communication and regulatory information. FDA.