Gadodiamide - Generic Drug Details

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

Gadodiamide is the generic ingredient in one branded drug marketed by Ge Healthcare and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for gadodiamide. One supplier is listed for this compound.

Summary for gadodiamide

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	7
Patent Applications:	2,490
What excipients (inactive ingredients) are in gadodiamide?	gadodiamide excipients list
DailyMed Link:	gadodiamide at DailyMed

Recent Clinical Trials for gadodiamide

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

Sponsor	Phase
GEHC (Sponsor)	Phase 4
Guerbet	Phase 4
Bracco (Sponsor)	Phase 4

See all gadodiamide clinical trials

Pharmacology for gadodiamide

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

Anatomical Therapeutic Chemical (ATC) Classes for gadodiamide

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

US Patents and Regulatory Information for gadodiamide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	022066-001	Sep 5, 2007		DISCN	Yes	No
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123-001	Jan 8, 1993		RX	Yes	Yes
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	022066-002	Sep 5, 2007		DISCN	Yes	No

Expired US Patents for gadodiamide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123-001	Jan 8, 1993	5,362,475
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	022066-001	Sep 5, 2007	5,560,903
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123-001	Jan 8, 1993	5,560,903
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123-001	Jan 8, 1993	4,687,659
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	022066-002	Sep 5, 2007	5,560,903

Gadodiamide Market Analysis and Financial Projection Experimental

Gadolinium Market Dynamics and Financial Trajectory: Focus on Gadodiamide

Introduction to Gadolinium and Gadodiamide

Gadolinium, a rare-earth metal, is widely used in various industries, particularly in the healthcare sector for its application in magnetic resonance imaging (MRI) contrast agents. Gadodiamide, a gadolinium-based contrast agent, is one of the key products driving the growth of the gadolinium market.

Market Size and Growth

The global gadolinium market is experiencing significant growth, driven primarily by the increasing demand for diagnostic imaging procedures. As of 2024, the gadolinium market size is estimated to be around USD 5.883 billion, with a projected growth at a Compound Annual Growth Rate (CAGR) of 5.2% until 2034, reaching USD 9.672 billion by then[2].

Drivers of Market Growth

Increasing Prevalence of Chronic Diseases

The rise in chronic diseases such as cancer, diabetes, and cardiovascular disorders is a major driver for the gadolinium market. These diseases necessitate early and precise diagnostic imaging, which in turn increases the demand for gadolinium-based contrast agents like gadodiamide[2][3].

Advancements in Healthcare Infrastructure

Investments in healthcare infrastructure, particularly in regions like India and China, are boosting the adoption of advanced diagnostic technologies. This includes the use of MRI scans with gadolinium-based contrast agents, which are essential for precise diagnosis and treatment planning[2][4].

Technological Innovations

Research and development in gadolinium-based materials are leading to innovations in formulations, nanoparticle structures, and surface modifications. These advancements are aimed at developing products with better performance, safety, and efficiency, further driving market growth[2].

Government Policies and Regulations

Agreeable government policies and increased purchasing capacity for gadolinium are influencing market growth. For instance, partnerships and agreements to secure the supply of gadolinium are crucial for maintaining market stability[1].

Regional Market Dynamics

North America

North America dominates the gadolinium market, driven by advanced technology and higher usage of gadolinium in medical equipment. The region is expected to witness significant growth at a CAGR of 6.2% during the forecast period, fueled by the rising prevalence of long-term diseases and increasing private and government expenditures[1][4].

Asia-Pacific (APAC)

The APAC region, particularly countries like Japan and China, is driving the market due to the increasing demand for nuclear energy and the growing healthcare sector. India, for example, is expected to see a CAGR of 7.7% by 2034, driven by innovative healthcare trends and medical tourism[1][2].

Europe

Europe is also a significant market, with countries like Spain seeing a CAGR of 3.9% by 2034. The region's focus on sustainable resources and medical tourism contributes to the demand for gadolinium-based contrast agents[2].

Financial Trajectory

Revenue Projections

The gadolinium market, which includes products like gadodiamide, is projected to grow substantially. From a revenue of USD 5.883 billion in 2024, the market is expected to reach USD 9.672 billion by 2034, indicating a robust financial trajectory[2].

Segment Analysis

The medical and healthcare segment holds the largest share of the gadolinium market, with a forecasted CAGR of 5.5% during the forecast period. This segment's growth is driven by the increasing availability and use of MRI machines, with countries like Austria and France showing significant increases in MRI availability per million population[4].

Challenges and Opportunities

Challenges

• High Raw Material Costs: The fluctuation in raw material costs and the high cost of gadolinium itself can restrict market growth.
• Technical Expertise: A lack of technical experts in the extraction and processing of gadolinium can hamper market expansion[1][4].

Opportunities

• Diversification of Applications: Gadolinium is being explored for use in other sectors such as the lighting industry (e.g., LED bulbs) and magnetic bubble memory devices, offering new revenue streams[2].
• Research and Development: Ongoing R&D in gadolinium-based materials and formulations presents opportunities for innovation and market growth[2].

Key Players and Agreements

Companies like Zydus Lifesciences are entering into exclusive licensing and supply agreements for gadolinium-based MRI contrast agents. For example, Zydus has an agreement with Viwit Pharmaceuticals for the generic versions of GADAVIST and DOTAREM, which are expected to capture a significant market share in the US[5].

Impact of COVID-19

The COVID-19 pandemic affected the supply chain activities of the gadolinium market, leading to a temporary decline. However, the market is expected to recover and grow as new products with advanced technologies are launched and demand for diagnostic imaging increases[1].

Conclusion

The gadolinium market, driven by the demand for gadodiamide and other gadolinium-based contrast agents, is poised for significant growth. The increasing prevalence of chronic diseases, advancements in healthcare infrastructure, and technological innovations are key drivers. While challenges such as high raw material costs and the need for technical expertise exist, the market's diversification into new applications and ongoing R&D activities present substantial opportunities.

Key Takeaways

• The global gadolinium market is expected to grow at a CAGR of 5.2% until 2034.
• The medical and healthcare sector is the primary driver of the market.
• North America, APAC, and Europe are significant regions contributing to market growth.
• Challenges include high raw material costs and the need for technical expertise.
• Opportunities lie in the diversification of applications and ongoing R&D.

FAQs

What is the current market size of the gadolinium market?

The current market size of the gadolinium market is estimated to be around USD 5.883 billion in 2024[2].

What is the projected CAGR for the gadolinium market until 2034?

The projected CAGR for the gadolinium market until 2034 is 5.2%[2].

Which region dominates the gadolinium market?

North America dominates the gadolinium market, driven by advanced technology and higher usage in medical equipment[1][4].

What are the primary drivers of the gadolinium market?

The primary drivers include the increasing prevalence of chronic diseases, advancements in healthcare infrastructure, and technological innovations[2][3].

What are some of the challenges facing the gadolinium market?

Challenges include high raw material costs and the lack of technical expertise in extraction and processing[1][4].

Sources

1. Maximize Market Research: Gadolinium Market - Growth, Trends[1]
2. Future Market Insights: Gadolinium Market Size, Share, Trends & Forecast to 2034[2]
3. Mordor Intelligence: Contrast Media Market Report: Size, Share, Growth Analysis[3]
4. IndustryARC: Gadolinium Market Size Report, 2024-2030[4]
5. Biospace: Zydus announces exclusive licensing and supply agreement for two gadolinium-based MRI contrast agents[5]