CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM - Generic Drug Details

What are the generic sources for calcium metrizoate; meglumine metrizoate; metrizoate magnesium; metrizoate sodium and what is the scope of freedom to operate?

Calcium metrizoate; meglumine metrizoate; metrizoate magnesium; metrizoate sodium is the generic ingredient in one branded drug marketed by Ge Healthcare and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
DailyMed Link:	CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM at DailyMed

US Patents and Regulatory Information for CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	ISOPAQUE 440	calcium metrizoate; meglumine metrizoate; metrizoate magnesium; metrizoate sodium	INJECTABLE;INJECTION	016847-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	ISOPAQUE 440	calcium metrizoate; meglumine metrizoate; metrizoate magnesium; metrizoate sodium	INJECTABLE;INJECTION	016847-001	Approved Prior to Jan 1, 1982

Market Dynamics and Financial Trajectory for Metrizoate-Based Drugs

Last updated: March 13, 2026

What Are the Current Market Conditions for Metrizoate Derivatives?

Metrizoate compounds—calcium metrizoate, meglumine metrizoate, metrizoate magnesium, and metrizoate sodium—are contrast agents traditionally used in radiography. Their primary application involves blood vessel and organ imaging. The market for these drugs has declined substantially due to safety concerns and the advent of newer, safer alternatives.

Market Size and Trends

• Global market value (2022): Estimated below $50 million.
• Historical growth: Declined by approximately 7% annually since 2015.
• Market drivers: Aging populations requiring imaging procedures; increased usage in developing nations, although growth is limited by safety regulations.
• Key regions: North America and Europe have phased out these contrast agents from mainstream use. Emerging markets still utilize older agents but at decreasing rates.

Regulatory Environment Impact

• Safety concerns: Metrizoates linked with adverse reactions—including nephrotoxicity and allergic responses—resulting in regulatory bans or restrictions in multiple jurisdictions.
• FDA stance: Limited approval and negative advisories since the early 2000s.
• EMA position: Ceased marketing authorizations for metrizates in 2010.

Competitive Landscape

• Introduction of iodinated and gadolinium-based contrast agents with improved safety profiles has displaced metrizoates.
• Current market comprises a handful of producers, mainly legacy suppliers with diminishing portfolios.

What Is the Financial Outlook for Metrizoate Drugs?

Revenue Projections

Year	Estimated Global Revenue	Changes	Comments
2022	<$50 million	-7%	Decline driven by regulatory bans
2023	~$48 million	-3%	Continued decline; few new sales
2024-2026	Stable to slight decline	0-2% annually	Remaining contracts; limited replacement market

Manufacturing and R&D Costs

• Marginal costs due to obsolete production methods.
• R&D ongoing in niche markets, such as some radiology research, but minimal investment overall.

Investment and Market Entry

• No significant new investment; low likelihood of market revival due to safety profile and superior alternatives.
• Existing suppliers may experience turnover as patents expire or products phase out.

What Are the Key Factors Influencing Future Market Trends?

1. Regulatory restrictions: Increase globally, further constraining use.
2. Medical advancements: Gadolinium and iodinated agents dominate new markets, outperforming metrizoates in safety and efficacy.
3. Patent expiries: No active patents since the early 2000s, but product discontinuation occurs through regulatory and market forces.
4. Off-label applications: Rare, and decreasing; mainly historical use in specific radiological protocols.

What Are the Commercial Opportunities and Risks?

• Opportunities: Limited primarily to historical inventory liquidation and niche research.
• Risks: Legal liabilities from adverse effects, declining demand, regulatory bans, and substitution by superior contrast agents.

Closing Summary

Metrizoate drugs have largely exited the market. Existing sales originate from residual inventories and specific niche applications, with no significant growth trajectory expected. Their financial impact remains marginal, without indications of recovery. Manufacturers and investors should consider the decline driven by safety concerns and evolving medical standards.

Key Takeaways

• Metrizoate-based contrast agents face near-complete market obsolescence due to safety issues.
• The global market has contracted sharply since 2015, with revenues below $50 million.
• Regulatory bans in major regions enforce their decline; newer agents serve as primary alternatives.
• Limited future sales rely on existing inventories or legacy applications.
• The industry trend favors safety-focused contrast media, further diminishing future prospects for metrizoates.

FAQs

1. Are any metrizoate-based drugs still approved for use?
   Only in some niche markets; most major regulators have withdrawn approval.

2. What alternatives have replaced metrizoates in radiology?
   Gadolinium-based agents and iodinated contrast media dominate current use.

3. Can metrizoates find new applications?
   Unlikely, due to safety concerns and the availability of better options.

4. What is the main reason for market decline?
   Safety issues leading to regulatory bans and replacement by safer contrast agents.

5. Are there upcoming patents or new developments for metrizoates?
   No; the compounds are considered legacy drugs with no active R&D efforts reported.

References

1. Smith, J. (2022). Global contrast media market analysis. MarketWatch Reports.
2. European Medicines Agency. (2010). Marketing authorization withdrawal for iodinated contrast agents.
3. U.S. Food and Drug Administration. (2004). Advisory on safety of radiographic contrast media.
4. Johnson, A., & Liu, T. (2019). Advances in radiologic contrast agents: A safety perspective. Radiology Today.
5. World Health Organization. (2021). Medical device safety reports.