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Last Updated: March 19, 2026

HYPAQUE-76 Drug Patent Profile


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Which patents cover Hypaque-76, and when can generic versions of Hypaque-76 launch?

Hypaque-76 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in HYPAQUE-76 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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  • What is the 5 year forecast for HYPAQUE-76?
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Summary for HYPAQUE-76
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for HYPAQUE-76

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare HYPAQUE-76 diatrizoate meglumine; diatrizoate sodium INJECTABLE;INJECTION 086505-001 Approved Prior to Jan 1, 1982 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

HYPAQUE-76 Market Analysis and Financial Projection

Last updated: February 3, 2026

What Is the Current Investment Landscape for HYPAQUE-76?

HYPAQUE-76, a drug used primarily as a contrast agent in radiology, holds a niche but stable position in imaging procedures. Its market relies heavily on diagnostic imaging demand, regulatory approvals, and competitive positioning among contrast agents. The global contrast media market was valued at approximately $6.5 billion in 2022, with expected compound annual growth rate (CAGR) of 4.2% through 2030[1].

The drug's financial prospects depend on regulatory status, patent protections, manufacturing capacity, and adoption rates within radiology practices. Publicly available data indicate limited recent clinical trial activity or new patent filings concerning HYPAQUE-76, suggesting a mature product with stable but not expanding market share.

What Are the Key Market and Industry Fundamentals?

Market Size and Growth

  • Total contrast media market (2022): ~$6.5 billion.
  • Segment dominated by iodinated contrast agents, including HYPAQUE-76.
  • Growth driven by rising imaging procedures: about 400 million procedures globally in 2022.
  • CAGR forecast of 4.2%, with growth influenced by aging populations and increased diagnostic imaging.

Major Competitors and Substitutes

  • Competitors: Iohexol, Iodixanol, and other iodinated contrast media.
  • Substitutes include gadolinium-based agents for MRI; however, hybrid and emerging contrast agents fragment the market.
  • HYPAQUE-76's market share has been stable but faces increasing competition from newer, potentially safer agents.

Regulatory and Patent Trends

  • Original patents for HYPAQUE-76 have expired, limiting exclusivity.
  • Regulatory approvals vary by country; in the US, it has FDA approval for specific indications.
  • No recent major patent filings suggest limited patent-related market expansion opportunities.

Pricing and Reimbursement Dynamics

  • Contrast agent pricing varies regionally; in the US, typical pricing per procedure ranges from $20 to $50.
  • Reimbursement policies favor established contrast agents, maintaining steady revenue streams.
  • Pricing pressure may intensify with competition and market maturation.

What Are the Key Financial and Developmental Factors?

Manufacturing and Supply Chain

  • Established manufacturing processes with large-scale production capacity.
  • Supply chain stability influenced by raw material access and geopolitical factors.

R&D and Innovation

  • Minimal ongoing R&D investment; existing formulations are mature.
  • Future innovation likely depends on reformulations or new delivery methods, which are not currently active.

Regulatory Risks

  • Regulatory scrutiny around safety, especially concerning iodine-based agents and adverse reactions.
  • Potential restrictions arising from safety concerns could impact market access.

What Investment Risks and Opportunities Exist?

Risks

  • Market maturity limits growth potential.
  • Patent expirations reduce pricing power and exclusivity.
  • Emerging safety concerns could diminish demand if new agents demonstrate better safety profiles.
  • Regulatory changes favoring newer agents could erode market share.

Opportunities

  • Expansion into emerging markets with increasing healthcare infrastructure.
  • Potential development of improved formulations or delivery mechanisms.
  • Integration with evolving imaging technologies and personalized medicine.

Key Takeaways

HYPAQUE-76 operates in a mature, stable segment of the contrast media market. Its revenues are primarily driven by procedural volumes, with limited growth prospects due to patent expirations and market saturation. Competitive dynamics favor established agents, but emerging safety concerns and the rise of alternative imaging modalities pose risks. Investment in HYPAQUE-76 requires careful assessment of regional regulatory landscapes, pricing strategies, and capacity for incremental innovation.

FAQs

1. Is HYPAQUE-76 a good investment opportunity?
Given its mature status, limited growth, and patent expirations, HYPAQUE-76 does not present high-growth investment potential. It may generate steady cash flow but is unlikely to significantly appreciate unless new indications or formulations are developed.

2. What is the competitive advantage of HYPAQUE-76?
Its established regulatory approval and manufacturing infrastructure provide reliability, but it lacks recent innovation or patent protection to offer a significant competitive edge.

3. How does safety affect future prospects?
Adverse safety reports can lead to regulatory restrictions, affecting demand. Continuous safety assessment is critical for maintaining market access.

4. Are there opportunities in emerging markets?
Yes. Increased healthcare spending and more widespread imaging procedures in regions such as Asia-Pacific can provide growth opportunities, provided regulatory pathways are navigated successfully.

5. What should investors monitor?
Regulatory developments, patent status, new competing agents, safety profiles, and reimbursement policies are key factors that influence HYPAQUE-76’s market performance.


References

[1] IQVIA Institute for Human Data Science. "The Global Use of Medicine in 2022," 2022.

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