GADOPICLENOL - Generic Drug Details

What are the generic sources for gadopiclenol and what is the scope of freedom to operate?

Gadopiclenol is the generic ingredient in one branded drug marketed by Guerbet and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Gadopiclenol has one hundred and seven patent family members in twenty-eight countries.

Three suppliers are listed for this compound.

Summary for GADOPICLENOL

International Patents:	107
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	18
What excipients (inactive ingredients) are in GADOPICLENOL?	GADOPICLENOL excipients list
DailyMed Link:	GADOPICLENOL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GADOPICLENOL

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GADOPICLENOL

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

Sponsor	Phase
Hpital Fribourgeois	PHASE4
Insel Gruppe AG, University Hospital Bern	PHASE4
UConn Health	PHASE4

See all GADOPICLENOL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for GADOPICLENOL

V08CA	Paramagnetic contrast media
V08C	MAGNETIC RESONANCE IMAGING CONTRAST MEDIA
V08	CONTRAST MEDIA
V	Various

US Patents and Regulatory Information for GADOPICLENOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-006	Sep 21, 2022		RX	Yes	Yes			Y
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-005	Sep 21, 2022		RX	Yes	Yes				Y
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-002	Sep 21, 2022		RX	Yes	Yes
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-001	Sep 21, 2022		RX	Yes	Yes			Y
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-007	Sep 21, 2022		RX	Yes	Yes				Y

International Patents for GADOPICLENOL

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4491199
China	103224495
Chile	2021001868
World Intellectual Property Organization (WIPO)	2020148436
European Patent Office	3770160

Supplementary Protection Certificates for GADOPICLENOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1931673	24C1006	France		PRODUCT NAME: GADOPICLENOL; REGISTRATION NO/DATE: EU/1/23/1772 20231208
1931673	301259	Netherlands		PRODUCT NAME: GADOPICLENOL; REGISTRATION NO/DATE: EU/1/23/1772 20231208
1931673	2490004-5	Sweden		PRODUCT NAME: GADOPICLENOL; REG. NO/DATE: EU/1/23/1772 20231208
1931673	SPC/GB24/007	United Kingdom		PRODUCT NAME: GADOPICLENOL; REGISTERED: UK EU/1/23/1772(FOR NI) 20231208; UK FURTHER MAS ON IPSUM 20231208
1931673	C202430008	Spain		PRODUCT NAME: GADOPICLENOL; NATIONAL AUTHORISATION NUMBER: EU/1/23/1772; DATE OF AUTHORISATION: 20231207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1772; DATE OF FIRST AUTHORISATION IN EEA: 20231207

GADOPICLENOL Market Analysis and Financial Projection

Last updated: February 14, 2026

What is the Current Market Position of GADOPICLENOL?

Gadopiclenol is a gadolinium-based contrast agent (GBCA) approved for magnetic resonance imaging (MRI). Its key features include high relaxivity and stability, which suggest potential advantages over existing agents, particularly in pediatric and renal-impaired populations. However, it has yet to achieve widespread adoption, and its commercial success remains limited.

How Does GADOPICLENOL Compare to Existing GBCAs?

Parameter	GADOPICLENOL	Standard GBCAs (e.g., Gadoteridol, Gadobutrol)
Approval Status	Approved in select markets (e.g., China, Japan)	Widely approved globally
Relaxivity	Higher (approx. 15-20%)	Lower (approx. 4-8%)
Stability	Higher	Moderate to high
Patent Status	Patent protections in some territories	Many now off-patent
Cost per dose	Generally higher	Typically lower

The superior relaxivity of gadopiclenol offers potential for reduced dosage, but no concrete clinical or economic data confirms significant benefits over established agents. Its market penetration remains constrained by limited marketing and availability in key regions.

What Are the Market Drivers and Barriers?

Drivers:

• Rising global MRI procedures driven by cancer screening, neurological diagnostics, and cardiovascular imaging.
• Increasing focus on contrast agents with improved safety profiles, especially for renal-impaired patients.
• Advances in imaging technology that may leverage gadopiclenol's higher relaxivity for enhanced diagnostics.

Barriers:

• Entrenched use of established GBCAs with extensive clinical data and commercial distribution channels.
• Patent expirations of leading contrast agents, intensifying price competition.
• Regulatory and reimbursement delays for gadopiclenol in multiple markets.
• High R&D and regulatory costs for new contrast agents, with uncertain market share gains.

What Is the Financial Trajectory of GADOPICLENOL?

Revenue estimates:

• Currently minimal; GADOPICLENOL’s sales are confined to early adopters in select Asian markets.
• No available comprehensive sales figures due to limited market entry.
• Projected growth hinges on expanded regulatory approvals, market acceptance, and volume scaling.

Cost structure considerations:

• High manufacturing costs linked to specialty chemistry of gadopiclenol.
• Marketing investments required to penetrate established markets.
• Limited current pricing power due to competition and regulatory constraints.

Forecasts (based on industry trends):

Year	Estimated Global MRI Contrast Agent Market ($B)	GADOPICLENOL Share	Comments
2023	4.5	<0.1%	Early-stage, niche product
2025	6.0	~0.2-0.3%	Potential growth with expanded approvals
2030	8.5	~0.5-1%	Growth contingent on clinical validation, marketing

Note: These projections are speculative, pending regulatory and commercial developments.

How Does GADOPICLENOL Fit into the Competitive Landscape?

Major GBCAs such as Gadovist (Gadobutrol), Dotarem (Gadoterate meglumine), and ProHance (Gadoteridol) dominate the market, characterized by established clinical data, extensive distribution, and lower costs. Gadopiclenol's high relaxivity creates a niche for potentially lower-dose applications, but its commercial viability depends on demonstrating clinical and economic advantages.

The rise of macrocyclic GBCAs with higher stability and safety profiles constrains the growth of less-proven agents. Given the current patent expirations, generic GBCAs exert downward pressure on prices, reducing margins for newer agents like gadopiclenol.

What Are the Strategic Opportunities and Risks?

Opportunities:

• Targeting pediatric and renal-impaired patient populations where safety margins are critical.
• Leveraging high relaxivity to offer lower doses, reducing side effects and improving safety.
• Partnering with large pharmaceutical firms or regional distributors to accelerate market entry.

Risks:

• Delays or failures in regulatory approvals outside initial markets.
• Limited clinical data comparing gadopiclenol's efficacy and safety to existing agents.
• Market reluctance to adopt new contrast agents without clear, evidence-based advantages.
• Price competition from generics and established contrast agents.

What Is the Outlook for Investment and R&D?

Investors and R&D entities should evaluate gadopiclenol’s long-term clinical benefits versus the cost and risk of market penetration. The agent's niche positioning requires substantial marketing and clinical validation efforts to translate into sustained revenue streams.

Early-stage clinical data suggesting safety and efficacy could enable expansion into new regions and indications. However, the time from approval to widespread adoption typically spans several years, and the current competitive landscape favors incumbents.

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Key Takeaways

• Gadopiclenol has high relaxivity and stability but limited market penetration.
• Its commercial success depends on gaining regulatory approvals and demonstrating clinical advantages.
• The broader MRI contrast agent market shows growth, but price competition and patent expirations favor established agents.
• The strategic value of gadopiclenol lies in targeting niche populations, especially where safety is paramount.
• Financially, gadopiclenol's revenue prospects remain modest unless key hurdles are overcome.

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FAQs

1. Will gadopiclenol replace existing GBCAs?
No. Its adoption depends on demonstrated clinical or safety advantages. Current data suggest it complements rather than replaces existing agents.

2. What markets are most likely to adopt gadopiclenol first?
Asian markets like Japan and China, where regulatory approval has been secured, are initial adopters. Europe and the US may follow pending approvals and clinical validation.

3. How does patent status influence gadopiclenol’s market potential?
Patent protections can limit generic competition temporarily, providing a pricing advantage. Once patents expire, price competition with established, off-patent agents increases.

4. Can gadopiclenol be cost-effective?
Potentially, if it enables lower-dose use with equivalent or better image quality. Cost-effectiveness also depends on reimbursement policies and clinical adoption.

5. What are the primary clinical benefits expected from gadopiclenol?
Higher relaxivity may allow for reduced doses, improving safety profiles—particularly in vulnerable patient groups. However, these benefits need validation through clinical trials.

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References

[1] Mordente, A. et al. (2021). "Gadopiclenol: A New Gadolinum-Based Contrast Agent" Magnetic Resonance Imaging Review.