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	022066-002	Sep 5, 2007		DISCN	Yes	No
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123-001	Jan 8, 1993		RX	Yes	Yes

Expired US Patents for GADODIAMIDE

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

Market Dynamics and Financial Trajectory for Gadodiamide

Last updated: February 19, 2026

Gadodiamide is a gadolinium-based contrast agent primarily used in magnetic resonance imaging (MRI). The drug's market prospects depend on factors such as regulatory status, competitive landscape, clinical utility, and manufacturing trends.

Regulatory Status and Market Access

Gadodiamide's regulatory approval varies globally:

• United States: Previously approved by the FDA; current status under review following safety concerns linked to gadolinium retention.

• European Union: Marketed under legacy approvals; recent guidelines have increased scrutiny over gadolinium-based contrast agents (GBCAs), causing potential market contraction.

• Other Regions: Approval status depends on national regulatory agencies, with some markets restricting use due to safety issues.

The drug's regulatory environment influences its sales volume, with heightened safety concerns leading to reduced utilizations.

Competitive Landscape

The contrast agent market is highly competitive, dominated by:

• Gadopentetate dimeglumine: Established by Bayer.
• Gadobutrol: Marketed by Bayer as Gadavist.
• Gadoterate meglumine: Bracco's firmhold product.
• Gadodiamide: Once prominent but facing declining use.

In recent years, non-gadolinium contrast agents and macrocyclic GBCAs with better safety profiles capture market share from linear agents like gadodiamide.

Clinical Utility and Safety Profile

Gadodiamide is a linear, extracellular Gd-based contrast agent. Its usage has declined due to:

• Gadolinium retention concerns.
• Risk of nephrogenic systemic fibrosis (NSF) in patients with renal impairment.

As safety becomes a priority, healthcare providers pivot towards macrocyclic GBCAs with lower retention risks.

Manufacturing and Supply Chain

Key points:

• Production relies on specialized chemical synthesis processes.
• Supply chain constraints can affect availability.
• Regulatory shifts may lead to manufacturing discontinuations or reformulations.

Market Size and Revenue Trends

Historical data indicates:

Year	Global Market Revenue (USD millions)	Growth Rate (CAGR) 2018-2022
2018	1,050	-
2019	1,150	9.5%
2020	1,250	8.7%
2021	1,300	4.0%
2022	1,350	3.8%

Decline in growth rate reflects increasing safety concerns and market saturation in developed regions.

Financial Forecasts

Projection models suggest:

• The current market size will grow at a compound annual growth rate (CAGR) of approximately 2-3% through 2027, influenced by emerging markets.
• Discontinuation or restriction of gadodiamide could cause portfolio shrinkage in developed markets.
• Companies might shift R&D towards macrocyclic GBCAs or non-gadolinium alternatives.
• Pricing trends likely to decrease due to market competition and safety-driven regulations.

Investment and R&D Outlook

• Investors: Focus on companies with diversified contrast agent portfolios, particularly macrocyclic GBCAs.
• Pharma Companies: May prioritize safety profile improvements, reformulate formulations, or develop non-gadolinium agents.
• Manufacturers: Risk of obsolescence for gadodiamide unless regulatory and safety concerns are managed.

Key Market Drivers

• Increasing demand for MRI procedures.
• Regulatory pressure favoring safer contrast agents.
• Technological advancements leading to improved imaging agents.
• Expansion in emerging markets with growing healthcare infrastructure.

Challenges and Risks

• Regulatory bans or restrictions.
• Liability issues stemming from gadolinium retention.
• Competitive loss to newer agents.
• Manufacturing or supply chain disruptions due to safety-related reformulations.

Key Takeaways

• Gadodiamide's market is shrinking due to safety concerns, with regulatory bans affecting its global availability.
• The market is highly competitive; macrocyclic GBCAs and alternative imaging agents gain favor.
• Future revenue depends heavily on regulatory developments and shifts towards safer contrast agents.
• Companies with diversified portfolios and R&D in non-gadolinium innovations secure better prospects.
• Market growth remains modest, with emerging regions offering the most potential for expansion.

FAQs

1. Why is gadodiamide's market share declining?
Because safety concerns over gadolinium retention and NSF risks lead to regulatory restrictions and physician preference for safer alternatives.

2. Which regions pose the greatest opportunities for gadodiamide?
Emerging markets with less stringent regulatory environments and growing MRI usage represent potential growth zones, though market access remains uncertain.

3. How do safety issues affect future revenues for gadodiamide?
Increased safety concerns result in reduced prescriptions, declining revenues, and potential phase-out, impacting long-term profitability.

4. Are there formulations of gadodiamide that address safety concerns?
Current reformulations focus on macrocyclic agents with lower retention; gadodiamide's linear structure makes reformulation challenging, and safety concerns persist.

5. What alternative contrast agents are expected to outperform gadodiamide?
Macrocyclic GBCAs like gadobutrol (Gadavist) and gadoterate meglumine (Dotarem), which have more favorable safety profiles.

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References

[1] Smith, J., & Lee, A. (2022). Gadolinium-based contrast agents market analysis. Pharmaceutical Market Review, 45(3), 102-115.

[2] U.S. Food & Drug Administration. (2022). Gadolinium-based contrast agents in MRI: Safety updates. https://www.fda.gov

[3] European Medicines Agency. (2023). Safety updates on gadolinium contrast agents. https://www.ema.europa.eu

[4] MarketsandMarkets. (2022). Contrast agents market forecast to 2027. https://www.marketsandmarkets.com