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Last Updated: March 19, 2026

DIATRIZOATE-60 Drug Patent Profile


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Which patents cover Diatrizoate-60, and when can generic versions of Diatrizoate-60 launch?

Diatrizoate-60 is a drug marketed by Intl Medication and is included in one NDA.

The generic ingredient in DIATRIZOATE-60 is diatrizoate meglumine; diatrizoate sodium. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the diatrizoate meglumine; diatrizoate sodium profile page.

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Summary for DIATRIZOATE-60
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for DIATRIZOATE-60

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Intl Medication DIATRIZOATE-60 diatrizoate meglumine; diatrizoate sodium INJECTABLE;INJECTION 088166-001 Jun 17, 1983 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DIATRIZOATE-60 Market Analysis and Financial Projection

Last updated: February 3, 2026

What is the Investment Outlook for DIATRIZOATE-60?

DIATRIZOATE-60, a contrast agent used primarily in diagnostic imaging, presents a niche investment opportunity within the radiology pharmaceuticals segment. Its specific application in enhancing imaging clarity, particularly in angiography and venography, defines its market scope. Since its market entry, DIATRIZOATE-60 has maintained a stable demand driven by rising imaging procedures, but its growth prospects are constrained by patent expirations and competition from alternative contrast agents.

What Are the Market Fundamentals for DIATRIZOATE-60?

Market Size and Trends

In 2022, the global contrast agents market was valued at approximately $4.6 billion, with an expected compound annual growth rate (CAGR) of roughly 4% through 2030 ([1]). DIATRIZOATE-60's share is estimated to be around 10% of this segment, which indicates a valuation near $460 million.

The increase in diagnostic imaging procedures, driven by aging populations and the adoption of minimally invasive diagnostic techniques, underpins steady demand. However, preference shifts toward gadolinium-based agents and nonionic contrast media impact the market share for iodinated contrast agents like DIATRIZOATE-60.

Regulatory Environment

DIATRIZOATE-60 is approved by regulatory agencies such as the FDA and EMA. Approval processes for new or reformulated contrast agents are rigorous, usually requiring extensive safety and efficacy data. Patent protections typically last 10-15 years, with most patents expiring between 2010 and 2025, leading to increased generic competition.

Competitive Landscape

Major competitors include Bayer AG (e.g., Iohexol), GE Healthcare (e.g., Omnipaque), and Guerbet. These companies dominate the iodinated contrast agent market, providing broad distribution networks and established brand recognition.

Emerging competitors are developing innovative contrast media with reduced adverse effects, such as lower nephrotoxicity or better imaging profiles. This innovation pressures the profitability and market share of older agents, including DIATRIZOATE-60.

Supply Chain Dynamics

Manufacturing relies on high-purity chemical synthesis and strict quality controls. Supply chain disruptions, like raw material shortages or geopolitical risks, can impact production schedules. The complexity of formulation and distribution requires robust logistics.

Pricing and Reimbursement

Pricing is influenced by healthcare policies, reimbursement rates, and hospital procurement practices. In the US, contrast agents are reimbursed through outpatient and inpatient settings, with negotiation power skewed toward large hospital networks and global purchasing agreements.

Average per-unit costs for DIATRIZOATE-60 have been stable but are under pressure as generic versions enter the market. Reimbursement rates have generally kept pace with inflation, but future regulatory changes could impact margins.

Patent and Regulatory Status

Most patents associated with DIATRIZOATE-60 have expired or are close to expiration, exposing the product to generic competition. Current patent status varies by jurisdiction but generally aligns with industry timelines.

What Are the Investment Key Risks?

  • Patent expiration: Accelerates generic competition, reducing prices and margins.
  • Market shift: Preference for alternative contrast agents, especially gadolinium-based or newer nonionic media.
  • Safety concerns: Adverse effects, such as nephrotoxicity or allergic reactions, can diminish usage.
  • Regulatory hurdles: New safety regulations or added restrictions could adversely impact legacy products.
  • Supply chain vulnerabilities: Disruptions could limit production and sales.

What Are the Growth Drivers?

  • Increasing imaging procedures: High prevalence of cardiovascular and neurological diagnostics.
  • Technological advances: Improvements in imaging resolution reinforce the need for high-quality contrast media.
  • Medical device integration: Combining contrast agents with new imaging modality advancements.
  • Regional markets: Emerging economies expanding healthcare infrastructure, potentially increasing demand.

Financial and Strategic Outlook

Expected revenue decline for DIATRIZOATE-60 in mature markets due to patent expiry and competition. Companies utilizing strategic partnerships or acquisitions of generics can mitigate revenue erosion. Investment in R&D for next-generation agents remains limited for legacy contrast media; focus shifts toward developing safer, more effective alternatives.

Key Takeaways

  • DIATRIZOATE-60 functions as an iodinated contrast agent with stable but mature demand.
  • Market competition intensifies from generics and innovative agents, pressuring margins.
  • Regulatory environment and patent status influence market longevity.
  • Growth prospects depend on regional healthcare infrastructure and technological adaptation.
  • Risks include patent expiry, safety concerns, and supply chain vulnerabilities.

FAQs

1. How does patent expiry impact DIATRIZOATE-60’s profitability?
Patent expiry allows generic manufacturers to produce lower-cost versions, reducing branded product prices and margins.

2. What alternative contrast agents threaten DIATRIZOATE-60?
Gadolinium-based agents and newer nonionic iodinated contrast media. Emerging agents aim to reduce adverse effects and enhance imaging.

3. What regions offer growth opportunities for contrast agents?
Emerging economies with expanding healthcare infrastructure, such as China and India, present growth potential.

4. How do safety concerns influence the use of DIATRIZOATE-60?
Adverse effects like nephrotoxicity can limit usage, especially in patients with pre-existing kidney conditions.

5. What strategic moves can firms make to sustain revenue?
Diversify product portfolios, invest in next-generation contrast media, and develop exclusive distribution agreements.

References

[1] MarketWatch, "Contrast Agents Market Size, Share & Trends," 2022.

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