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 two branded drugs marketed by Bracco and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for gadoteridol

US Patents:	0
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	14
Patent Applications:	1,838
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		RX	Yes	Yes
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003		RX	Yes	Yes

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	4,885,363
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992	4,885,363
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003	5,846,519
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003	5,474,756
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992	6,143,274
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992	5,846,519
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992	5,474,756

Gadoteridol Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gadoteridol Injection

Introduction

Gadoteridol, a gadolinium-based contrast agent, is widely used in magnetic resonance imaging (MRI) to enhance the visibility of internal body structures. Understanding the market dynamics and financial trajectory of gadoteridol injection is crucial for investors, healthcare providers, and pharmaceutical companies.

Global Market Size and Growth

The global gadoteridol injection market has been experiencing significant growth. As of 2023, the market size was valued at approximately USD 300 million. It is anticipated to reach around USD 500 million by 2032, indicating a robust growth trajectory[1][4].

Market Drivers

Several factors drive the growth of the gadoteridol injection market:

• Increasing Demand for MRI Procedures: The rising need for diagnostic imaging due to an aging population and an increase in chronic diseases is a key driver.
• Advancements in MRI Technology: Improvements in MRI technology have made it more accurate and efficient, leading to higher demand for contrast agents like gadoteridol.
• Expanding Healthcare Infrastructure: The growth of healthcare infrastructure in developing countries is also contributing to the increased demand for gadoteridol injections.

Market Restraints

Despite the growth, there are several restraints to consider:

• Regulatory Challenges: Strict regulatory requirements and the need for continuous safety monitoring can slow market growth.
• Side Effects and Safety Concerns: Gadolinium-based contrast agents, including gadoteridol, have raised concerns about potential side effects such as nephrogenic systemic fibrosis (NSF) in patients with severe kidney disease.
• Competition from Other Contrast Agents: The market is competitive, with other gadolinium-based contrast agents like gadobutrol and gadopentetate dimeglumine also vying for market share[2].

Competitive Landscape

The competitive landscape of the gadoteridol injection market is characterized by a few key players. These companies invest heavily in research and development to improve the safety and efficacy of their products. The competition also drives innovation, leading to better patient outcomes.

Pricing Dynamics

The pricing of gadoteridol injections can be influenced by several factors:

• Generic Competition: While gadoteridol is a branded product, the generic drug market can impact pricing strategies. Generic drugs often lead to price reductions as they enter the market and compete with branded products[3].
• Regulatory Pressures: Regulatory bodies may impose price controls or other measures to ensure affordability, which can affect the financial trajectory of the drug.
• Market Forces: The balance between supply and demand, as well as the presence of other contrast agents, influences pricing.

Financial Projections

Financial projections for the gadoteridol injection market are positive, with a compound annual growth rate (CAGR) expected over the next decade. Here are some key financial metrics:

• Revenue Growth: The market is expected to grow from USD 300 million in 2023 to USD 500 million by 2032, indicating a significant revenue increase.
• Market Share: Companies that successfully navigate regulatory and competitive challenges are likely to maintain or increase their market share.
• Profit Margins: Profit margins may be influenced by production costs, regulatory compliance, and competitive pricing strategies.

Regional Market Analysis

The global market for gadoteridol injections is segmented by region:

• North America and Europe: These regions are expected to remain significant markets due to advanced healthcare infrastructure and high demand for MRI procedures.
• Asia-Pacific: This region is anticipated to show rapid growth due to increasing healthcare spending and infrastructure development.
• Latin America and Africa: These regions are also expected to contribute to market growth, albeit at a slower pace compared to North America, Europe, and Asia-Pacific.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of gadoteridol injections:

• FDA Approvals and Guidelines: Regulatory approvals and guidelines set by bodies like the FDA are critical for the market entry and continued use of gadoteridol.
• Safety Monitoring: Continuous safety monitoring and post-marketing surveillance are essential to ensure the safe use of gadolinium-based contrast agents[2].

Technological Advancements

Technological advancements in MRI and contrast agent development are key to the market's growth:

• Improved Imaging Techniques: Advances in MRI technology enhance the diagnostic capabilities, making gadoteridol more valuable.
• New Formulations: Research into new formulations and delivery methods can improve safety and efficacy, further driving market growth.

Patient Safety and Efficacy

Patient safety and efficacy are paramount:

• Clinical Trials and Studies: Continuous clinical trials and studies ensure that gadoteridol meets the highest safety and efficacy standards.
• Post-Marketing Surveillance: Ongoing surveillance helps in identifying any potential side effects and in making necessary adjustments to ensure patient safety[2].

Market Trends

Several trends are shaping the market for gadoteridol injections:

• Personalized Medicine: The trend towards personalized medicine may lead to more targeted use of contrast agents.
• Digital Health: Integration with digital health technologies can enhance the diagnostic capabilities and patient outcomes.
• Sustainability: There is a growing focus on sustainability in healthcare, which could influence production and distribution practices.

Key Takeaways

• The global gadoteridol injection market is expected to grow significantly, reaching USD 500 million by 2032.
• Market drivers include increasing demand for MRI procedures, advancements in MRI technology, and expanding healthcare infrastructure.
• Regulatory challenges, side effects, and competition from other contrast agents are key restraints.
• Financial projections indicate a positive growth trajectory, influenced by market forces, regulatory pressures, and competitive dynamics.

FAQs

What is the current market size of the gadoteridol injection market?

The global gadoteridol injection market was valued at approximately USD 300 million in 2023[1].

What is the projected growth of the gadoteridol injection market?

The market is anticipated to reach around USD 500 million by 2032, indicating a significant growth trajectory[1].

What are the main drivers of the gadoteridol injection market?

The main drivers include increasing demand for MRI procedures, advancements in MRI technology, and expanding healthcare infrastructure.

What are the key restraints in the gadoteridol injection market?

Key restraints include regulatory challenges, potential side effects, and competition from other contrast agents.

How does the regulatory environment impact the gadoteridol injection market?

The regulatory environment, including FDA approvals and guidelines, plays a crucial role in market entry and continued use of gadoteridol injections[2].

Sources

1. Dataintelo - Gadoteridol Injection Market Research Report 2032
2. FDA - N201-277S008 Gadobutrol Clinical PREA
3. Econstor - Trajectories of prices in generic drug markets: What can we infer ...
4. QYResearch - Global Gadoteridol Injection Market Research Report 2024