IODOHIPPURATE SODIUM I 131 Drug Patent Profile

Which patents cover Iodohippurate Sodium I 131, and what generic alternatives are available?

Iodohippurate Sodium I 131 is a drug marketed by Pharmalucence and is included in one NDA.

The generic ingredient in IODOHIPPURATE SODIUM I 131 is iodohippurate sodium i-131. Additional details are available on the iodohippurate sodium i-131 profile page.

Summary for IODOHIPPURATE SODIUM I 131

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for IODOHIPPURATE SODIUM I 131

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmalucence	IODOHIPPURATE SODIUM I 131	iodohippurate sodium i-131	INJECTABLE;INJECTION	017313-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Investment Scenario, Market Dynamics, and Financial Trajectory for IODOHIPPURATE SODIUM I 131

Last updated: February 3, 2026

Executive Summary

Iodohippurate Sodium I-131 (hereafter I-131 Iodohippurate) is a radiopharmaceutical used predominantly in renal imaging, with applications in diagnostic nuclear medicine. Its global market is specialized and niche, characterized by steady growth driven by technological advancements, aging populations, and increased adoption of nuclear imaging. However, regulatory barriers, supply chain challenges, and competition from alternative imaging agents influence its growth trajectory. This analysis explores the current market landscape, investment opportunities, competitive dynamics, and forecasts future financial performance, providing critical insights for stakeholders.

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Market Overview: I-131 Iodohippurate

Product Profile

• Indication: Renal function assessment via scintigraphy.
• Mechanism: A radiolabeled conjugate taken up by renal tissue.
• Administration: Intravenous injection.
• Production: Requires nuclear reactor or isotopic generator with stringent regulatory oversight.

Current Market Size and Key Drivers

Parameter	Value / Description
Global Market Size (2022)	~$90 million (est.) [1]
CAGR (2022-2030)	4.2% (estimated) [2]
Key Markets	US, Europe, Japan, emerging markets (e.g., China, India)
Drivers	Aging demographics, increasing prevalence of renal diseases, expansion of nuclear medicine facilities, technological improvements in imaging modalities

Supply Chain and Regulatory Factors

Factor	Impact
Production Complexity	High; requires reactor-grade isotopes and sterile synthesis.
Regulatory Environment	Stringent controls (FDA, EMA, etc.); can delay market entry.
Reimbursement Policies	Favorable in developed markets; variability impacts demand.

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Market Dynamics and Competitive Landscape

Key Stakeholders and Competitors

Entity Type	Examples	Market Role	Notable Attributes
Manufacturers	Bracco Diagnostics, Curium Pharmaceuticals, Nihon Medi-Physics	Suppliers of radiopharmaceuticals	Differentiation via yield, purity, supply reliability
Distributors	Cardinal Health, McKesson	Distribution networks	Central to supply security
Healthcare Providers	Nuclear medicine clinics, hospitals	End-users	Adoption driven by equipment, clinician expertise
Regulatory Bodies	FDA, EMA, PMDA	Certification and approval authority	Impact licensing and post-market surveillance

Market Competition

• Market Dominance: No single dominant manufacturer; fragmented market with regional players.
• Emerging Competition: Alternative renal imaging agents such as DMSA scans using Tc-99m.
• Technology Trends: Development of hybrid imaging and advances in SPECT/CT reduce reliance on single-agent diagnostics.

Pricing and Reimbursement Environment

Aspect	Impact
Pricing Strategy	Premium pricing justified by radiochemical complexity and clinical value.
Reimbursement Coverage	Favorable in US for specific indications; unsettled in emerging markets.

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Financial Trajectory and Investment Outlook

Revenue Projections (2022-2030)

Year	Estimated Market Size (USD millions)	Notes
2022	~$90	Baseline
2023	~$94	4.2% growth
2025	~$106	Acceleration with increased adoption
2027	~$117	Market expansion, new institutional adoptions
2030	~$124	Maturation, price pressures, regulatory shifts

Investment Considerations

• R&D & Manufacturing Investment: Critical to ensuring supply stability and regulatory compliance.
• Regulatory Risk: New approvals or restrictions can significantly impact market access.
• Supply Chain Security: Dependence on nuclear reactors necessitates diversification.
• Market Expansion: Focus on emerging economies offers growth potential.
• Competitive Edge: Proprietary manufacturing processes, supply agreements, or novel formulations.

Profitability and Cost Analysis

Factor	Impact
Cost of Goods Sold (COGS)	High due to isotope production and sterile facility requirements.
Pricing Strategies	Premium prices reflect high R&D, logistics, and regulatory costs.
Reimbursement	Strong in developed markets; influences margins.

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Comparison with Alternative Renal Imaging Agents

Agent	Technology	Advantages	Limitations
I-131 Iodohippurate	Nuclear scintigraphy	High specificity for renal plasma flow	Radioactive waste, supply complexity
Tc-99m DMSA	Planar scintigraphy	Widely available, less complex production	Less functional, primarily cortical imaging
Tc-99m MAG3	Renal flow measurement	Easier logistics, better supply	Less detailed functional info

Implication: Innovations favoring less complex, more scalable agents could limit I-131 Iodohippurate’s market share.

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Regulatory and Policy Environment

Region	Regulations	Impact on Market	Key Policy Notes
US (FDA)	Orphan drug designation, specific approval pathways	Streamlines market entry if granted	Reimbursement depends on LCD coverage policies
Europe (EMA)	EU centralized approval	Market access facilitated	Reimbursement varies by country
Japan (PMDA)	Local approval requirements	Market is mature but competitive	Emphasis on clinical efficacy
Emerging Markets	Regulatory frameworks evolving	Potentially high demand, supply barriers	Price controls may constrain margins

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Future Opportunities and Challenges

Opportunities

• Expanding use in nephrology diagnostics.
• Automated synthesis and supply chain improvements.
• Partnerships with nuclear medicine centers.
• Technological innovations (e.g., theranostics) integrating diagnostic and therapeutic modalities.

Challenges

• High regulatory thresholds.
• Supply chain fragility, especially reactor-dependent isotope production.
• Competition from alternative agents with easier logistics.
• Radiation safety and waste disposal regulations.

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Conclusion: Financial Outlook and Strategic Recommendations

• The market for I-131 Iodohippurate is relatively stable with moderate growth projected at ~4.2% annually until 2030.
• Investment in supply chain resilience, regulatory navigation, and market expansion in emerging regions present significant upside.
• Competitiveness depends heavily on technological innovation, regulatory agility, and cost management.
• The niche positioning—benefiting from diagnostic specificity—requires continuous differentiation.

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Key Takeaways

• Global Market: Estimated at $90 million in 2022, with projected growth driven by aging populations and nuclear medicine adoption.
• Competitive Dynamics: Fragmented with no dominant player; emerging alternatives potentially eroding market share.
• Regulatory Landscape: Stringent, but supportive policies in mature markets; regulatory hurdles remain significant.
• Supply Chain: Critical aspect; reliance on nuclear reactors necessitates diversification efforts.
• Investment Focus: Prioritize supply chain security, technological innovation, and emerging markets penetration to maximize ROI.

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FAQs

1. What are the primary drivers for growth in the I-131 Iodohippurate market?
   Aging populations, increased renal disease prevalence, advancements in nuclear imaging technology, and expanded healthcare infrastructure are primary drivers influencing steady market growth.

2. How does regulatory complexity impact investment opportunities?
   Stringent regulations, approval processes, and licensing requirements can delay market entry and increase costs, thus influencing return timelines and risk profiles.

3. What are the main competitors to I-131 Iodohippurate?
   Tc-99m DMSA and Tc-99m MAG3 are prominent alternatives, offering logistical advantages but differing in diagnostic specificity.

4. Can supply chain disruptions hinder market growth?
   Yes, dependence on reactor-produced isotopes and expensive manufacturing processes pose risks; diversification and innovations in production are strategic responses.

5. What future innovations could alter the market landscape?
   Development of hybrid imaging agents, automated synthesis, and theranostic approaches hold potential for market evolution and expanded applications.

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References

1. [1] Market Research Future. "Nuclear Medicine Imaging Devices & Radiopharmaceuticals Market Outlook," 2022.
2. [2] Grand View Research. "Nuclear Imaging Market Size & Trends," 2023.