DOTAREM Drug Patent Profile

Which patents cover Dotarem, and what generic alternatives are available?

Dotarem is a drug marketed by Guerbet and is included in one NDA.

The generic ingredient in DOTAREM 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 Dotarem

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

Summary for DOTAREM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	31
Patent Applications:	460
Drug Prices:	Drug price information for DOTAREM
What excipients (inactive ingredients) are in DOTAREM?	DOTAREM excipients list
DailyMed Link:	DOTAREM at DailyMed

See drug prices for DOTAREM

Recent Clinical Trials for DOTAREM

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

Sponsor	Phase
Columbia University	PHASE1
Johns Hopkins University	Phase 4
Boehringer Ingelheim	Phase 2

See all DOTAREM clinical trials

Pharmacology for DOTAREM

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

US Patents and Regulatory Information for DOTAREM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Guerbet	DOTAREM	gadoterate meglumine	SOLUTION;INTRAVENOUS	204781-005	Mar 31, 2017	AP	RX	Yes	Yes
Guerbet	DOTAREM	gadoterate meglumine	SOLUTION;INTRAVENOUS	204781-004	Mar 20, 2013	AP	RX	Yes	Yes
Guerbet	DOTAREM	gadoterate meglumine	SOLUTION;INTRAVENOUS	204781-002	Mar 20, 2013	AP	RX	Yes	Yes
Guerbet	DOTAREM	gadoterate meglumine	SOLUTION;INTRAVENOUS	204781-003	Mar 20, 2013	AP	RX	Yes	Yes
Guerbet	DOTAREM	gadoterate meglumine	SOLUTION;INTRAVENOUS	204781-001	Mar 20, 2013	AP	RX	Yes	Yes

Dotarem Market Dynamics, Financial Trajectory, Patent Position, and Generic Risk

Last updated: August 12, 2026

Dotarem, the branded gadolinium-based contrast agent containing gadoterate meglumine, is a mature but expanding MRI product. Guerbet has grown Dotarem through broader MRI utilization, U.S. adoption, hospital tenders, and demand for macrocyclic gadolinium agents with a strong safety profile. The principal commercial risk is generic erosion rather than biosimilar competition or loss of the underlying molecule patent.

Dotarem remains strategically important to Guerbet because it is one of the company’s core imaging products. Product-level revenue is not separately reported, so the financial trajectory must be assessed through Guerbet’s Imaging business and group results. The product’s future growth depends on MRI procedure volumes, market share against competing gadolinium agents, pricing discipline, and the pace of generic substitution.

What is Dotarem and who markets it?

Dotarem is an intravenous MRI contrast agent based on gadoterate meglumine, a macrocyclic gadolinium-based contrast agent. Guerbet developed and commercializes the product globally.

Item	Details
Brand	Dotarem
Active ingredient	Gadoterate meglumine
Drug class	Gadolinium-based contrast agent
Primary use	Contrast-enhanced magnetic resonance imaging
Molecular structure	Macrocyclic, ionic gadolinium complex
Originator	Guerbet
U.S. approval	2013
U.S. regulatory application	NDA 204781
Main competitors	Gadavist, ProHance, MultiHance, generic gadoterate meglumine
Administration	Intravenous injection
Core customers	Hospitals, outpatient imaging centers, radiology groups, distributors

Dotarem is used in adults and pediatric patients for a range of contrast-enhanced MRI examinations. Its macrocyclic structure is commercially relevant because macrocyclic agents are generally viewed as more kinetically stable than linear gadolinium agents. The product competes on clinical familiarity, safety perception, supply reliability, reimbursement, and contracting terms.

How large is the Dotarem market?

The worldwide market for gadolinium-based MRI contrast agents is measured in the low-single-digit billions of dollars, with growth tied to MRI procedure volumes and replacement of older linear agents. Dotarem is one of the leading products in the macrocyclic segment.

The market has several structural characteristics:

1. MRI utilization continues to rise in oncology, neurology, cardiology, orthopedics, and emergency imaging.
2. Macrocyclic agents have gained share from several linear gadolinium products.
3. Hospital procurement is price-sensitive and increasingly consolidated.
4. Generic competition is strongest in mature markets, including the United States and Europe.
5. Product shortages or manufacturing disruptions can temporarily shift market share between suppliers.

Dotarem’s addressable market is larger than its branded prescription market because most contrast agents are purchased through hospitals, imaging networks, group purchasing organizations, and public procurement systems. The economic buyer is often a hospital pharmacy or radiology department rather than an individual physician.

How does Dotarem compare with competing MRI contrast agents?

Product	Active ingredient	Manufacturer	Structural class	Commercial position
Dotarem	Gadoterate meglumine	Guerbet	Macrocyclic ionic	Core Guerbet product; broad global presence
Gadavist	Gadobutrol	Bayer	Macrocyclic nonionic	Strong global branded competitor
ProHance	Gadoteridol	Bracco	Macrocyclic nonionic	Established macrocyclic competitor
MultiHance	Gadobenate dimeglumine	Bracco	Linear ionic	Differentiated by hepatobiliary properties, but less central to routine MRI
Magnevist	Gadopentetate dimeglumine	Bayer	Linear ionic	Mature product with declining strategic relevance
Generic gadoterate meglumine	Gadoterate meglumine	Multiple suppliers	Macrocyclic ionic	Primary price-based threat to Dotarem

Dotarem competes most directly with Gadavist and ProHance in routine MRI. The products are not interchangeable in every clinical setting without regard to labeling, dose, institutional protocol, and procurement rules, but hospitals often evaluate them as members of the same macrocyclic contrast category.

What is Guerbet’s financial trajectory?

Guerbet does not generally disclose Dotarem revenue as a separate line item. Public financial reporting instead presents consolidated revenue and business-line performance. Dotarem is part of Guerbet’s Imaging portfolio, which also includes other contrast agents, injection systems, and related products.

Guerbet’s financial trajectory has been shaped by four factors:

• Recovery in imaging procedure volumes after the COVID-19 disruption.
• Expansion of Dotarem in the United States and other growth markets.
• Pricing and volume pressure from generic contrast agents.
• Currency movements, raw-material costs, and hospital procurement pricing.

Guerbet reported consolidated revenue of approximately €785 million in 2023, compared with approximately €753 million in 2022, according to its 2023 annual reporting. The company attributed growth to its imaging portfolio, commercial execution, and regional performance, although product-level Dotarem revenue was not separately reported (Guerbet, 2024).

Financial indicator	2022	2023	Interpretation
Guerbet consolidated revenue	Approximately €753 million	Approximately €785 million	Continued recovery and growth
Dotarem revenue	Not separately disclosed	Not separately disclosed	Must be inferred from portfolio and regional data
Core revenue driver	Imaging products	Imaging products	Dotarem remains a key branded contributor
Main margin risks	Input costs, pricing, inflation	Input costs, pricing, inflation	Mature-product economics remain sensitive to tenders

The financial case for Dotarem is therefore one of durable cash generation rather than rapid pharmaceutical-style growth. Guerbet can expand sales through increased MRI volume and share gains, but unit pricing will face pressure as generic gadoterate becomes more available.

What is driving Dotarem market growth?

Rising MRI procedure volumes

MRI is used across a broad range of diagnostic pathways. Growth in cancer imaging, brain imaging, musculoskeletal diagnostics, and cardiovascular imaging increases demand for contrast-enhanced examinations.

Dotarem has greater exposure to procedural volume than to a narrow disease area. This diversification reduces dependence on one indication but makes the product sensitive to hospital capital budgets, radiology staffing, reimbursement, and scanner utilization.

Shift toward macrocyclic gadolinium agents

Concerns about gadolinium retention and the historical use of less stable linear agents have supported demand for macrocyclic products. Regulatory agencies have maintained different positions by product and jurisdiction, but hospitals often favor macrocyclic agents when selecting routine MRI contrast protocols.

This market shift benefits Dotarem, Gadavist, and ProHance. It does not create a permanent pricing advantage because the principal macrocyclic products increasingly compete with generic versions.

U.S. commercial expansion

Dotarem received U.S. approval in 2013 and has had years to build physician familiarity, formulary access, and distributor relationships. Guerbet has used the U.S. market as an important growth platform, with sales affected by hospital contracting and competition from Bayer, Bracco, and generic manufacturers.

The U.S. is commercially attractive because of its large MRI installed base and high diagnostic imaging spend. It is also exposed to rapid generic substitution once approved products achieve hospital formulary access.

Supply reliability

Contrast media manufacturing requires specialized facilities, validated sterile filling, and access to gadolinium-related raw materials. Supply disruptions can affect the entire market. In 2022, shortages affecting iodinated and gadolinium contrast products demonstrated that hospitals may shift purchasing between suppliers when one manufacturer experiences a production or logistics problem.

A reliable supply position can temporarily protect Dotarem volumes even when branded pricing is under pressure.

When does Dotarem lose exclusivity?

Dotarem’s principal exclusivity risk is already present because the product was approved in the United States in 2013 and is based on a mature active ingredient. The original compound and manufacturing patent estate does not provide a current, durable barrier comparable to the protection surrounding a newer small-molecule drug.

The commercially relevant exclusivity timeline is:

Event	Timing
Dotarem introduced in international markets	Before U.S. launch
U.S. FDA approval	March 2013
Original active-ingredient patent protection	Historically expired or commercially exhausted before the current market period
U.S. generic entry risk	Active and increasing as approvals and supplier participation expand
Current protection	Regulatory labeling, manufacturing know-how, trademarks, contracts, and market access rather than a strong composition patent

The exact commercial impact of generic entry varies by country. Some markets experience gradual substitution through tenders, while others retain branded products through physician familiarity or hospital-specific procurement policies.

What patents protect Dotarem?

Dotarem is not protected today by a high-value, unexpired composition-of-matter patent comparable to the patent estate around a newly launched pharmaceutical.

Composition and formulation patents

Gadoterate meglumine is a mature gadolinium complex. The commercially important molecule-level patent protection dates to the early development of gadoteric acid and related gadolinium chelates. Those rights do not create a meaningful current barrier to FDA-approved generic gadoterate products.

Any remaining patents would need to be evaluated at the specific jurisdiction, formulation, manufacturing process, or use level. The most relevant potential protections are:

• Manufacturing processes for gadoterate meglumine.
• Sterile injectable formulations.
• Container and vial configurations.
• Premixed or prefilled delivery systems.
• Specific dosing or imaging protocols.
• Injector integration and workflow systems.

These rights are narrower than composition patents and are harder to use to block all generic entry.

Orange Book status

The FDA Orange Book is the key U.S. source for listed patents and regulatory exclusivity associated with approved drug products. Dotarem’s commercial protection does not appear to depend on a significant active Orange Book patent barrier. Its competitive exposure is therefore primarily regulatory and commercial rather than patent-based (U.S. Food and Drug Administration, n.d.-a).

A generic applicant can challenge any applicable listed patent through a Paragraph IV certification. Where no relevant patent is listed, an applicant may pursue an abbreviated new drug application without a Paragraph IV dispute against a listed Dotarem patent.

Are there Paragraph IV challenges to Dotarem?

Paragraph IV risk is relevant because gadoterate meglumine is a small-molecule injectable drug eligible for the abbreviated new drug application pathway. The key issue is whether a generic applicant identifies a listed patent as invalid, unenforceable, or not infringed.

The risk profile is different from that of a recently launched oral drug:

• Dotarem has no widely recognized current composition patent blocking generic entry.
• Injectable generics may proceed through product-specific FDA requirements.
• Hospital contracts can determine commercial substitution faster than patent litigation.
• Litigation may focus on formulation, manufacturing, labeling, or narrow use claims if such patents are listed or asserted.

Public regulatory records should be reviewed for each abbreviated application and any associated patent certifications. The absence of a major public Paragraph IV dispute does not eliminate generic risk. It indicates that market entry may occur through regulatory approval and procurement competition rather than a headline patent case.

What is the FDA regulatory status of Dotarem?

Dotarem is FDA-approved as an injectable MRI contrast agent under NDA 204781. The product is regulated as a prescription drug and is administered under professional supervision. Its label covers contrast-enhanced MRI uses across specified patient populations and imaging indications (U.S. Food and Drug Administration, n.d.-b).

The principal FDA issues affecting the product are:

• Safety monitoring for gadolinium retention.
• Manufacturing quality and sterile-product compliance.
• Labeling for pediatric and adult use.
• Generic approval standards for injectable gadoterate meglumine.
• Postmarketing surveillance and pharmacovigilance.

Dotarem is not a biologic. Biosimilar regulation under the Public Health Service Act does not apply.

Does Dotarem face biosimilar risk?

No. Dotarem faces generic-drug competition, not biosimilar competition.

Gadoterate meglumine is a chemically defined small-molecule drug. A competing product can seek approval through the ANDA pathway by demonstrating pharmaceutical equivalence and bioequivalence or satisfying applicable FDA requirements for injectable products. A biosimilar application would be inappropriate for the product’s regulatory category.

This distinction matters commercially. Generic entry can occur without reproducing the originator’s clinical development program. The competitive barrier is therefore manufacturing, regulatory compliance, supply reliability, and contracting rather than biologic comparability.

Which companies challenge Dotarem commercially?

The competitive set includes established contrast-media companies and generic injectable manufacturers.

Company	Relevant competitive asset	Risk to Dotarem
Bayer	Gadavist and broader radiology portfolio	High branded competition
Bracco	ProHance and other contrast media	High in hospitals and imaging centers
Generic injectable manufacturers	Generic gadoterate meglumine	High price and substitution risk
Guerbet	Dotarem, other contrast products, injectors	Originator defense and portfolio bundling

Competition is often decided by hospital contracts, group purchasing arrangements, distributor terms, product availability, and radiologist preference. The presence of a branded competitor can be more important than patent status in markets where hospitals maintain multiple approved contrast agents.

What generic launch scenarios exist for Dotarem?

Scenario 1: Limited generic penetration

Dotarem retains substantial share because hospitals value supplier reliability, product familiarity, and a multi-source contrast portfolio. Price erosion is moderate, and Guerbet protects volume through contracting.

Scenario 2: Two-supplier generic competition

One or two generic manufacturers enter with competitive pricing. Hospitals begin converting routine MRI procedures, while complex protocols and established radiology groups retain Dotarem. Revenue declines gradually, but the product remains commercially relevant.

Scenario 3: Broad generic substitution

Multiple suppliers obtain approval, and group purchasing organizations adopt low-cost gadoterate contracts. Dotarem experiences substantial price erosion and volume loss. Guerbet’s ability to bundle Dotarem with injectors or other imaging products becomes central to retention.

The most probable outcome is segmented substitution. Large hospital systems and price-sensitive public tenders are likely to move first. Academic centers, private imaging groups, and sites with established protocols may transition more slowly.

How strong is the Dotarem patent estate?

Dotarem’s current patent strength is weak to moderate, depending on the jurisdiction and claim type.

Protection category	Current strength	Commercial relevance
Composition of matter	Weak or expired	Does not block ordinary generic entry
Core formulation	Limited	May support narrow product claims
Manufacturing process	Moderate if technically difficult	Can raise operational barriers
Method of use	Limited to specific claims	Unlikely to block routine MRI substitution broadly
Device or injector integration	Moderate	Supports portfolio and workflow differentiation
Trademark	Strong while maintained	Preserves brand identity, not market exclusivity
Regulatory approval	Meaningful	Requires generic competitors to meet FDA standards

Guerbet’s most defensible assets are likely manufacturing know-how, quality systems, supply-chain capability, customer relationships, and the ability to sell Dotarem alongside injection systems and other contrast products.

What licensing deals affect Dotarem?

Dotarem’s core commercial identity is associated with Guerbet rather than a widely disclosed third-party licensing structure. Publicly visible licensing arrangements are less important to the product’s economics than Guerbet’s own manufacturing, distribution, and regional commercialization infrastructure.

The principal deal-related considerations are:

• Regional distribution agreements.
• Hospital and group purchasing contracts.
• Distributor relationships.
• Procurement arrangements in Europe and emerging markets.
• Portfolio bundling with Guerbet injection systems.

No major publicly disclosed licensing transaction appears to determine Dotarem’s current global market position. The product’s economics are primarily controlled through Guerbet’s commercial network and manufacturing footprint.

What geographic markets are most important?

Dotarem has a broad international footprint, with the United States and Europe representing major commercial markets. Regional performance differs materially.

United States

The United States offers high MRI utilization and substantial revenue per procedure. It also has strong generic substitution risk and concentrated hospital purchasing.

Europe

European markets are more exposed to public tenders, national reimbursement rules, and price controls. Guerbet’s French heritage and regional infrastructure support market access, but tender losses can rapidly affect volume.

Asia-Pacific

MRI capacity expansion and rising diagnostic demand support long-term growth. Regulatory approvals, distributor quality, local manufacturing requirements, and pricing controls determine profitability.

Emerging markets

Volume growth can be attractive, but lower prices, currency volatility, registration requirements, and distributor dependence reduce per-unit economics.

What manufacturing and intellectual-property barriers protect Dotarem?

The largest practical barriers are manufacturing and quality-related rather than patent-related. Dotarem is a sterile injectable product requiring:

• Consistent production of the gadolinium chelate.
• Validated sterile filling.
• Tight control of impurities and particulate matter.
• Container-closure integrity.
• Regulatory-compliant batch release.
• Reliable supply of specialized raw materials.
• Pharmacovigilance and postmarketing quality systems.

These requirements can delay generic entry and limit the number of reliable suppliers. They do not prevent entry indefinitely. Once multiple manufacturers qualify, the market can shift quickly toward price competition.

What is the revenue exposure for Guerbet?

Dotarem is a material product within Guerbet’s imaging portfolio, but Guerbet does not publicly isolate its revenue, operating profit, or gross margin. Product exposure should therefore be modeled through scenarios rather than a reported Dotarem income statement.

A useful commercial framework is:

Variable	Upside driver	Downside driver
MRI volume	More scans and contrast-enhanced procedures	Hospital budget pressure
Market share	Macrocyclic preference and supply reliability	Generic substitution
Price	Premium for established brand and quality	Tender and GPO discounts
Geography	U.S. and emerging-market expansion	Currency and local pricing controls
Manufacturing	Scale and reliable supply	Sterile production costs and disruptions
Portfolio	Bundling with injectors and other products	Narrow product concentration

Dotarem is likely to remain a cash-generating product, but its growth rate should moderate as the product matures and generic competition expands. The main valuation question for Guerbet is whether volume growth and share gains offset price erosion.

What patent litigation affects Dotarem?

Dotarem does not have a widely recognized, high-value patent litigation profile comparable to leading oncology, immunology, or diabetes drugs. Litigation risk is more likely to arise from:

• Generic ANDA disputes.
• Manufacturing or formulation claims.
• Contracting and supply disagreements.
• Product liability and gadolinium-retention claims.
• Regulatory enforcement involving manufacturing quality.

The absence of major patent litigation reduces near-term legal uncertainty but also indicates that patent rights are unlikely to delay generic competition materially.

Key Takeaways

• Dotarem is Guerbet’s branded gadoterate meglumine MRI contrast agent.
• The product benefits from rising MRI volumes and the market shift toward macrocyclic gadolinium agents.
• Its closest branded competitors are Gadavist and ProHance.
• Dotarem revenue is not separately disclosed; Guerbet reported approximately €785 million in consolidated revenue in 2023.
• Dotarem is a mature small-molecule injectable, not a biologic, so biosimilar risk does not apply.
• Generic gadoterate meglumine is the principal long-term threat.
• The original composition patent estate does not provide a meaningful current exclusivity barrier.
• The U.S. regulatory reference is NDA 204781.
• The Orange Book does not appear to show a significant active patent barrier supporting long-term Dotarem exclusivity.
• Manufacturing quality, sterile supply, hospital contracts, and brand familiarity are more important than patent rights in the current market.
• Revenue erosion is likely to be gradual at first and faster if multiple generic suppliers secure hospital and group-purchasing contracts.

FAQs

Is Dotarem more stable than linear gadolinium contrast agents?

Yes. Dotarem uses a macrocyclic gadolinium complex, which is generally more stable than many linear gadolinium complexes. Stability is one reason macrocyclic agents have gained share in routine MRI.

Can hospitals substitute generic gadoterate meglumine for Dotarem automatically?

Substitution depends on local law, hospital formulary policy, procurement contracts, labeling, and physician protocols. Generic approval does not guarantee automatic substitution in every jurisdiction.

Does Dotarem have pediatric approval?

Yes. The FDA label includes pediatric use for specified MRI indications and dosing requirements. Pediatric labeling can support clinical familiarity but is unlikely to prevent generic competition where generics receive comparable labeling.

Is Dotarem used in computed tomography?

No. Dotarem is an MRI contrast agent. Computed tomography generally uses iodinated contrast media, which is a separate product category.

Could Guerbet defend Dotarem through injector-system bundling?

Yes. Bundling Dotarem with Guerbet’s injection systems, service capabilities, and contrast portfolio can improve account retention. This is a commercial defense rather than a patent-based exclusivity strategy.

References

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

2. U.S. Food and Drug Administration. (n.d.-a). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/

3. U.S. Food and Drug Administration. (n.d.-b). Dotarem (gadoterate meglumine) injection prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/

4. U.S. Food and Drug Administration. (n.d.-c). Drugs@FDA: FDA-approved drugs, Dotarem NDA 204781. https://www.accessdata.fda.gov/scripts/cder/daf/

5. European Medicines Agency. (n.d.). Gadoteric acid and gadolinium-containing contrast agents: Safety information. https://www.ema.europa.eu/