GADODIAMIDE - Generic Drug Details

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

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:	8
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
Zhejiang Provincial People's Hospital	PHASE3
IQVIA (Sponsor)	Phase 4
Bayer AG (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

Market Dynamics and Financial Trajectory for Gadolodiamide

Last updated: July 31, 2025

Introduction

Gadolodiamide, a gadolinium-based contrast agent (GBCA), represents a specialized segment within the diagnostic imaging market. Primarily utilized in magnetic resonance imaging (MRI), gadolodiamide enhances diagnostic accuracy and clinical outcomes. As the global radiology landscape evolves with technological innovation and regulatory shifts, understanding the market dynamics and financial pathway of gadolodiamide is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Overview

Global MRI Contrast Agent Market

The MRI contrast agent market, valued at approximately USD 2.66 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of around 5.4% through 2030. The rising prevalence of neurological, cardiovascular, and oncological disorders, coupled with increasing adoption of MRI diagnostics, fuels the demand for contrast agents such as gadolinium-based compounds (GBCAs). Gadolodiamide forms a niche within this market, due to its specific properties and regulatory profile.

Gadolodiamide: Market Position and Usage

Gadolodiamide, branded historically as Omniscan, was developed as a macrocyclic GBCA offering enhanced stability compared to linear agents. Its utilization significantly declined following safety concerns related to gadolinium deposition, leading to regulatory restrictions in certain jurisdictions. Nonetheless, it remains in use within specific diagnostic contexts, especially where macrocyclic agents are preferred given their lower propensity for releasing free gadolinium ions.

Regulatory landscape

Regulatory bodies, notably the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have imposed restrictions on certain linear GBCAs, emphasizing macrocyclic formulations like gadodiamide for safety. The FDA issued a black box warning regarding gadolinium deposition in tissues, resulting in a cautious market environment. As a result, gadodiamide’s market share has contracted, but ongoing demand persists due to its particular clinical applications and existing stock.

Market Dynamics

Factors Driving Growth

• Aging Population and Disease Prevalence: Rising incidences of neurological disorders (e.g., multiple sclerosis, brain tumors), cardiovascular diseases, and cancers boost demand for MRI diagnostics. Contrast agents like gadodiamide are integral in these imaging procedures.
• Advancements in MRI Technology: Enhanced imaging resolution and faster protocols increase reliance on contrast-enhanced MRI, indirectly supporting gadolodiamide usage.
• Expanding Healthcare Infrastructure: Development in emerging markets with expanding healthcare budgets improves diagnosis rates, helping sustain demand.
• Regulatory Preferences for Macrocyclic Agents: Macrocyclic GBCAs are favored due to their higher kinetic stability, favoring continued use of certain formulations despite safety concerns about linear agents.

Challenges and Constraints

• Safety Concerns and Gadolinium Retention: Accumulation of gadolinium in brain tissues, observed with linear agents, has led to regulatory scrutiny. This has discouraged widespread use of gadolodiamide, particularly in regions with strict regulations.
• Market Saturation and Competition: The proliferation of newer, safer contrast agents and alternative imaging modalities limits growth prospects.
• Regulatory Restrictions and Market Exit: Several suppliers have withdrawn gadolodiamide due to safety concerns and market pressures, reducing supply and affecting availability.
• Pharmacovigilance and Litigation Risks: Ongoing lawsuits and safety communications pose financial risks to manufacturers and impact the market environment.

Opportunities

• Niche Applications in Specific Patient Populations: Gadolodiamide remains valuable in cases where macrocyclic agents are contraindicated or unavailable.
• Research and Development: Innovations aiming to improve safety profiles or develop alternative contrast mechanisms open avenues for specialized formulations.
• Emerging Markets: Growing healthcare investments in Asia-Pacific and Latin America present potential, albeit constrained by regulatory frameworks.

Financial Trajectory

Revenue Trends

Gadolodiamide’s revenue has experienced significant decline since the initial safety concerns emerged in the late 2000s. For instance, Pfizer, which marketed Omniscan, reported that its sales diminished considerably from peak sales of USD 400 million annually pre-2010 to below USD 70 million in subsequent years [1]. This decline reflects regulatory actions, market withdrawals, and preference shifts.

Market Share Evolution

While global contracts for gadolodiamide have contracted, its relative market share remains stable within niche markets where macrocyclic agents are critical or mandated. The future revenue trajectory is expected to stabilize, given the limited scope for growth and ongoing safety concerns.

Pricing Dynamics

Pricing for gadolodiamide has remained relatively stable in constrained markets; however, increased regulatory oversight and competition from newer agents could induce price reductions or procurement shifts, pressuring margins.

Investment Considerations

Manufacturers with existing gadodiamide formulations may face reduced investment returns given the declining sales trajectory. Conversely, strategic repositioning toward safer, next-generation contrast agents offers alternative pathways.

Strategic Outlook

• Short-term Outlook: Continued decline in market volume due to safety concerns and regulatory restrictions. Limited opportunities for expansion.
• Medium-term Outlook: Market stabilization with usage confined to specific niche applications and regions with relaxed regulatory frameworks.
• Long-term Outlook: Likely phased out in core markets, replaced by safer, more stable macrocyclic agents, or alternative imaging technologies such as PET and ultrasound.

Regulatory Timeline and Impact

• 2007-2015: Initial concerns about gadolinium retention surface, leading to increased scrutiny.
• 2015: EMA classifies certain linear GBCAs as “approved for restricted use only.”
• 2017: FDA issues warnings and advises caution against repetitive use.
• 2020 onward: Market exit or restricted use of gadodiamide in major markets, with some geographic variability.

Conclusion

Gadolodiamide’s market landscape has transformed from expansion to contraction driven by safety concerns and regulatory interventions. Its financial trajectory reflects declining revenues, with future prospects limited to niche applications and certain geographic regions. Companies seeking to capitalize on these dynamics should focus on safety profile improvements, diversification into alternative contrast agents, and strategic market positioning.

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Key Takeaways

• The global demand for MRI contrast agents drives steady peripheral demand for gadolodiamide, but safety issues significantly constrain growth.
• Regulatory restrictions have led to reduced market penetration, causing pharmaceutical companies to reevaluate investments in gadolodiamide development and marketing.
• The product remains relevant in specific clinical contexts but faces imminent obsolescence as newer, safer agents commercialize.
• Market stakeholders should prioritize safety innovations, diversify portfolios, and monitor legislative developments to mitigate financial risks.
• Diversification into emerging markets and collaboration with clinical research initiatives can provide survival pathways for legacy formulations like gadodiamide.

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FAQs

1. Why has the usage of gadodiamide declined globally?
Safety concerns related to gadolinium retention, regulatory restrictions, and the emergence of safer macrocyclic agents have significantly reduced gadodiamide’s usage worldwide.

2. What are the primary safety issues associated with gadodiamide?
Gadolodiamide, like linear GBCAs, is associated with gadolinium deposition in brain tissues, raising concerns about long-term safety, particularly in patients requiring repeated administration.

3. Which regions still utilize gadodiamide extensively?
Usage remains relatively higher in regions with less stringent regulatory environments or where alternative agents are unavailable, such as certain low-resource settings.

4. Is there ongoing research to improve gadolinium-based contrast agents?
Yes, research focuses on developing macrocyclic agents with enhanced safety, or entirely alternative imaging contrast mechanisms, to mitigate gadolinium retention risks.

5. What are the future market prospects for gadodiamide?
Most forecasts predict a continued decline, with eventual obsolescence in developed markets. Its niche status may persist short-term where current regulatory decisions permit, but long-term outlook suggests phase-out in favor of newer agents.

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References:

[1] Pfizer Inc., "Omniscan Sales Data," 2012-2022.