Gadoteridol - Generic Drug Details

What are the generic sources for gadoteridol and what is the scope of patent protection?

Gadoteridol is the generic ingredient in three branded drugs marketed by Hainan Poly and Bracco, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for gadoteridol

US Patents:	0
Tradenames:	3
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	14
Patent Applications:	2,038
What excipients (inactive ingredients) are in gadoteridol?	gadoteridol excipients list
DailyMed Link:	gadoteridol at DailyMed

Recent Clinical Trials for gadoteridol

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

Sponsor	Phase
University of Alabama at Birmingham	Early Phase 1
University of Utah	Early Phase 1
University of Alabama at Birmingham	Phase 1

See all gadoteridol clinical trials

Pharmacology for gadoteridol

Drug Class	Paramagnetic Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity

Anatomical Therapeutic Chemical (ATC) Classes for gadoteridol

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

US Patents and Regulatory Information for gadoteridol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992	AP	RX	Yes	Yes
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003		RX	Yes	Yes
Hainan Poly	GADOTERIDOL	gadoteridol	INJECTABLE;INJECTION	218749-001	Feb 11, 2025	AP	RX	No	No

Expired US Patents for gadoteridol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992

Market Dynamics and Financial Trajectory for Gadoteridol

Last updated: July 29, 2025

Introduction

Gadoteridol is a gadolinium-based contrast agent (GBCA) primarily used in magnetic resonance imaging (MRI) procedures. Its core function is to enhance the quality of imaging by improving the visibility of tissues, blood vessels, and certain pathological processes. As the demand for advanced diagnostic imaging rises globally, understanding the market dynamics and financial trajectory of gadoteridol offers vital insights for stakeholders across pharmaceutical and healthcare sectors.

Market Overview and Growth Drivers

Increasing MRI Utilization

The global MRI market is expanding sharply, driven by an aging population, rising prevalence of chronic diseases, and technological advancements. According to Grand View Research, the MRI market size is projected to reach USD 9.17 billion by 2028, growing at a CAGR of 4.2% (2021-2028) [1]. Contrast agents like gadoteridol significantly contribute to this growth by enabling more precise diagnostics.

Preference for Macrocyclic GBCAs

Gadoteridol is a macrocyclic GBCA, characterized by higher thermodynamic and kinetic stability compared to linear agents. This stability reduces the risk of gadolinium release and related adverse effects, especially nephrogenic systemic fibrosis (NSF). Regulatory emphasis on safer contrast agents, coupled with clinical preference, bolsters gadoteridol’s market position.

Regulatory Landscape

Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have enhanced guidelines favoring macrocyclic GBCAs, citing a lower propensity for gadolinium deposition. This regulatory shift favors gadoteridol's adoption, especially as some linear agents face restrictions or withdrawal.

Emerging Markets

Growth in emerging markets, particularly Asia-Pacific, driven by expanding healthcare infrastructure and increasing diagnostic imaging capabilities, presents expanding opportunities for gadoteridol, aligning with global trends towards accessible and safer diagnostic solutions.

Market Challenges

Gadolinium Deposition Concerns

Concerns over gadolinium retention in body tissues have induced caution among healthcare providers. While macrocyclic agents like gadoteridol are perceived as safer, ongoing debates about long-term effects necessitate continuous monitoring and may impact the market dynamics adversely.

Competition from Alternative Agents

The presence of several other GBCAs—including both macrocyclic (e.g., gadobutrol, gadoterate meglumine) and linear agents—intensifies competitive pressures. Price sensitivity and safety profiles significantly influence market share distribution.

Cost Considerations

Manufacturing macrocyclic GBCAs involves complex synthesis processes, often resulting in higher prices compared to linear counterparts. Cost considerations influence hospital procurement strategies, especially in budget-constrained regions.

Financial Trajectory and Revenue Forecasts

Current Revenue Performance

Gadoteridol, marketed under brands such as ProHance (Brand name by Bracco Imaging), reported global revenues estimated at approximately USD 250-300 million annually as of 2022. Its revenue is primarily derived from established markets like North America and Europe, with increasing sales in the Asia-Pacific region.

Market Penetration and Share

ProHance holds a significant segment within macrocyclic GBCAs, competing closely with gadobutrol (Gadavist/ Gadovist). Its market share is sustained by its high safety profile, regulatory approvals, and clinical preference for its performance.

Projected Growth Trends

Analysts project a CAGR of 3-5% for gadoteridol over the next five years, driven by increasing MRI volumes and banked on the trend of safer contrast agents. However, growth might be tempered by the proliferation of generics and price competition.

Impact of Biosimilars and Generics

As patents expire, generic versions are expected to enter the market, exerting downward pressure on prices. Nonetheless, brand loyalty and regulatory approvals serve as barriers, preserving a certain revenue threshold for incumbent products.

Strategic Factors Influencing Future Financial Trajectory

Innovation and Development

Continued research into safer, more effective contrast agents can influence market dynamics. Gadoteridol’s entry into advanced MRI techniques, such as higher field imaging, can expand its utility.

Regulatory Endorsement

Positive regulatory decisions, such as expanded indications or new approval regions, can boost sales. Conversely, restrictions owing to safety concerns could diminish revenues.

Pricing Strategies

Stakeholders might adopt differentiated pricing models, including bundling with imaging services or volume-based discounts, affecting overall revenue streams.

Market Expansion Initiatives

Developing markets present opportunities for growth. Investments in education and physician awareness can foster adoption and expand revenues.

Conclusion

Gadoteridol’s market dynamics are shaped by increasing MRI usage, safety perceptions favoring macrocyclic agents, and global regulatory trends. Its financial trajectory appears stable, with moderate growth expected contingent on technological, regulatory, and competitive developments. While potential challenges like increasing competition and safety concerns persist, strategic innovation and market expansion can sustain revenue streams for gadoteridol manufacturers.

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Key Takeaways

• The global MRI market’s growth drives demand for gadoteridol, supporting its revenue stability despite market competition.
• Regulatory emphasis on macrocyclic GBCAs is advantageous for gadoteridol, enhancing its safety profile and market acceptance.
• Patent expirations and the advent of generics pose challenges; however, brand loyalty and regulatory barriers may mitigate rapid revenue decline.
• Market expansion in emerging economies offers significant growth opportunities, provided stakeholders focus on affordability and awareness.
• Innovation in imaging techniques and further safety studies can influence gadoteridol’s financial prospects favorably.

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Frequently Asked Questions (FAQs)

1. What distinguishes gadoteridol from other gadolinium-based contrast agents?
   Gadoteridol is a macrocyclic GBCA, offering higher thermodynamic and kinetic stability compared to linear agents, which reduces the risk of gadolinium retention and related adverse effects, making it a safer choice in various clinical settings.

2. How does safety concerns about gadolinium deposition impact gadoteridol’s market?
   Safety concerns promote preference for macrocyclic agents like gadoteridol, potentially increasing its market share. However, ongoing debates about long-term gadolinium retention may also lead to cautious prescribing, affecting sales growth.

3. What is the revenue outlook for gadoteridol over the next five years?
   Revenue for gadoteridol is expected to grow modestly at a CAGR of approximately 3-5%, driven by rising MRI procedures and expanding use in emerging markets, balanced against generic competition and regulatory developments.

4. Which regions offer the most growth potential for gadoteridol?
   Emerging markets in Asia-Pacific display significant growth potential due to expanding healthcare infrastructure and increasing diagnostic imaging access. North America and Europe will continue to be key markets owing to high MRI utilization.

5. What factors could influence gadoteridol’s future market share?
   Factors include technological innovation, regulatory decisions, safety profile perceptions, competitive pricing of generics, and the degree of global expansion efforts undertaken by manufacturers.

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References

[1] Grand View Research. “MRI Market Size, Share & Trends Analysis Report.” 2022.