Iodohippurate sodium i-123 - Generic Drug Details

What are the generic drug sources for iodohippurate sodium i-123 and what is the scope of patent protection?

Iodohippurate sodium i-123 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 iodohippurate sodium i-123

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	4
DailyMed Link:	iodohippurate sodium i-123 at DailyMed

US Patents and Regulatory Information for iodohippurate sodium i-123

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	NEPHROFLOW	iodohippurate sodium i-123	INJECTABLE;INJECTION	018289-001	Dec 28, 1984		DISCN	No	No

Market Dynamics and Financial Trajectory of I-123 Iodohippurate Sodium

Last updated: February 19, 2026

I-123 iodohippurate sodium is a diagnostic radiopharmaceutical used in nuclear medicine for renal imaging. Its market trajectory is directly influenced by diagnostic imaging trends, reimbursement policies, and the development of competing or complementary technologies. This analysis examines key market drivers, patent landscape, competitive environment, and financial outlook for I-123 iodohippurate sodium.

What is the current market status of I-123 iodohippurate sodium?

The market for I-123 iodohippurate sodium is mature and stable, serving a niche within diagnostic nuclear medicine. Its primary application is in assessing renal perfusion and function, often in cases of suspected or known renal artery stenosis. The compound allows for non-invasive imaging of kidney uptake and excretion, providing crucial data for diagnosis and treatment planning. Global demand is driven by the prevalence of renal diseases and the continued reliance on SPECT (Single-Photon Emission Computed Tomography) imaging for these assessments.

The compound's efficacy in its established indications underpins its current market position. While advanced imaging modalities like MRI and CT angiography are also utilized for renal assessment, I-123 iodohippurate sodium offers specific functional information that remains valuable. Its use is primarily concentrated in specialized imaging centers and hospitals with nuclear medicine departments.

Key Market Characteristics:

• Established Indication: Renal imaging for perfusion and function assessment.
• Technology Dependence: Relies on SPECT imaging infrastructure.
• Niche Market: Serves a specific diagnostic need within nuclear medicine.
• Stable Demand: Driven by chronic and acute renal conditions.
• Regulatory Approval: Requires adherence to stringent radiopharmaceutical manufacturing and distribution regulations.

The market size is not independently reported as a standalone entity but is part of the broader nuclear medicine diagnostics market, which was valued at approximately $4.7 billion in 2022 and is projected to grow at a CAGR of 6.2% from 2023 to 2030 [1]. I-123 iodohippurate sodium represents a segment within this larger market.

What is the patent landscape surrounding I-123 iodohippurate sodium?

The patent landscape for I-123 iodohippurate sodium itself is largely in the public domain. As a well-established diagnostic agent, the foundational patents protecting its chemical synthesis and initial therapeutic or diagnostic use expired decades ago. This lack of active, broad patent protection for the core compound means that market entry for generic manufacturers is technically feasible, provided they can meet regulatory hurdles.

However, innovation continues in related areas, potentially impacting the market indirectly:

• Improved Imaging Techniques: Patents related to enhanced SPECT/CT imaging hardware and software can improve the resolution and diagnostic accuracy of I-123 iodohippurate sodium scans, indirectly bolstering its utility.
• Novel Formulations or Delivery Methods: While less common for established radiotracers, patents might exist for modified formulations or improved methods of radiolabeling that enhance stability or biodistribution.
• New Indications or Combinations: Research into new diagnostic applications or combinations with other imaging agents or therapeutic interventions could lead to new patentable intellectual property, though this is less likely for a compound with such a defined primary use.
• Manufacturing Processes: Patents may exist for optimized, efficient, or cost-effective manufacturing processes for the radiolabeling of hippuran, particularly concerning the production of Iodine-123, which has a relatively short half-life (13.2 hours) [2].

Patent Status Summary:

• Core Compound Patents: Expired.
• Manufacturing Process Patents: Potential for existing or emerging patents.
• Imaging Technology Patents: Indirectly beneficial through enhanced diagnostic capabilities.
• New Indication Patents: Unlikely for established use.

Companies that hold manufacturing process patents or licenses for the production of Iodine-123 isotopes could maintain a competitive advantage. The primary barrier to market entry is not patent infringement for the compound itself, but rather the significant capital investment and regulatory expertise required for radiopharmaceutical production and distribution, including compliance with Good Manufacturing Practices (GMP) and radiopharmaceutical handling protocols.

Who are the key manufacturers and suppliers of I-123 iodohippurate sodium?

The supply chain for I-123 iodohippurate sodium is characterized by a limited number of specialized radiopharmaceutical manufacturers. Due to the short half-life of Iodine-123, production and distribution require a highly efficient logistical network operating close to imaging centers.

Key Players in the Radiopharmaceutical Market (Indirectly relevant to I-123 iodohippurate sodium supply):

While specific market share data for I-123 iodohippurate sodium is not publicly granular, major radiopharmaceutical companies are involved in the production of Iodine-123 labeled agents. These include:

• GE HealthCare: A significant player in diagnostic imaging and radiopharmaceuticals.
• Lantheus Medical Imaging: Known for its portfolio of diagnostic imaging agents.
• Curium Pharma: A global leader in diagnostic imaging.
• Nordion (a Sotera Health company): Involved in radioisotope production and distribution.

These companies typically have the infrastructure for producing and distributing short-lived radioisotopes like Iodine-123 and have established protocols for labeling various target molecules, including hippuran. The availability of Iodine-123 itself is a crucial factor, often sourced from cyclotrons or nuclear reactors.

Supply Chain Dynamics:

• Isotope Availability: Reliance on consistent Iodine-123 production.
• Specialized Manufacturing: Requires radiopharmaceutical GMP compliance.
• Logistical Complexity: Short half-life necessitates rapid, localized distribution.
• Regulatory Oversight: Strict FDA (or equivalent) approval and monitoring.

The competitive landscape is thus defined by operational efficiency, manufacturing capacity, and robust distribution networks rather than novel product pipelines for the core compound.

What is the competitive landscape for renal diagnostic imaging?

The competitive landscape for renal diagnostic imaging is multi-faceted, involving various imaging modalities and diagnostic agents, each with distinct strengths and weaknesses. I-123 iodohippurate sodium competes with:

1. Other Nuclear Medicine Agents:

• Technetium-99m (Tc-99m) labeled agents: Agents like Tc-99m DTPA (pentetic acid) are commonly used for glomerular filtration rate (GFR) estimation and renography. Tc-99m has a half-life of 6 hours, making it readily available and cost-effective. However, Iodine-123 offers superior imaging characteristics for SPECT due to its energy profile and longer half-life, allowing for more detailed functional assessment over time.
• Other Iodine-123 labeled agents: While less common for direct renal function, other I-123 agents might be used in conjunction or for evaluating specific renal pathologies.

2. Non-Nuclear Imaging Modalities:

• Computed Tomography Angiography (CTA) and Magnetic Resonance Angiography (MRA): These modalities excel at visualizing renal artery anatomy and detecting stenosis. They provide high-resolution structural information and are widely available. However, they do not directly measure renal function or perfusion in the same way as I-123 iodohippurate sodium. Contrast agents used in CTA/MRA carry their own risks, particularly for patients with compromised renal function.
• Ultrasound with Doppler: A non-invasive, widely accessible tool for initial renal assessment, capable of detecting blood flow abnormalities. However, its diagnostic accuracy for renal artery stenosis can be operator-dependent and less sensitive than CTA or MRA.
• Intravenous Pyelography (IVP) / Excretory Urography: An older imaging technique using contrast media to visualize the renal pelvis and ureters. Less commonly used now due to the availability of CT and MRI.

3. Functional Assessment Tests:

• Blood Tests: Serum creatinine and estimated GFR (eGFR) are standard markers of overall kidney function but do not localize the issue to renal artery stenosis.
• Plasma Renin Activity (PRA) and Angiotensin-Converting Enzyme (ACE) Inhibitor Renal Scintigraphy: These are functional tests that can indicate renovascular hypertension but are not direct imaging agents.

I-123 Iodohippurate Sodium's Competitive Positioning:

I-123 iodohippurate sodium remains valuable for its ability to provide:

• Direct functional assessment: Measures uptake, transit, and excretion by the kidneys.
• Differential renal function: Allows for comparison of function between individual kidneys.
• Assessment of renovascular hypertension: Particularly useful in evaluating the contribution of renal artery stenosis to hypertension.
• Post-intervention assessment: Can evaluate the success of revascularization procedures.

Its competition is not necessarily direct replacement but rather a complementary role within a broader diagnostic pathway. The choice of imaging modality often depends on the clinical question, patient factors, and local resource availability.

What is the financial trajectory and market outlook for I-123 iodohippurate sodium?

The financial trajectory of I-123 iodohippurate sodium is expected to be one of steady, incremental growth, mirroring the overall expansion of the diagnostic imaging market, with moderate increases in demand. Factors influencing this outlook include:

Drivers:

• Aging Population: The increasing elderly population worldwide is associated with a higher prevalence of chronic diseases, including those affecting renal health.
• Increasing Incidence of Renal Diseases: Factors like diabetes, hypertension, and cardiovascular disease contribute to a growing burden of kidney-related conditions.
• Advancements in SPECT/CT Technology: Improved hardware and software enhance the diagnostic capabilities of SPECT imaging, making I-123 iodohippurate sodium scans more informative and increasing their utilization.
• Reimbursement Policies: Favorable reimbursement rates for diagnostic nuclear medicine procedures by public and private payers support sustained demand.
• Clinical Guidelines: Inclusion in established diagnostic algorithms for suspected renovascular hypertension and other renal pathologies.

Challenges:

• Competition from Advanced Modalities: The increasing accuracy and accessibility of CTA and MRA for anatomical assessment of renal arteries pose a competitive challenge, potentially reducing the need for purely anatomical evaluation via nuclear imaging in some cases.
• Radiopharmaceutical Costs and Logistics: The cost of producing and distributing short-lived radioisotopes like Iodine-123, coupled with complex logistical requirements, can impact profit margins for manufacturers.
• Technological Obsolescence: While SPECT/CT is mature, ongoing advancements in PET/CT and other novel imaging technologies could, over the long term, shift diagnostic paradigms.
• Radiopharmaceutical Shortages: Global supply chain issues affecting radioisotopes can impact availability and price.

Market Outlook:

The market for I-123 iodohippurate sodium is projected to grow at a CAGR of approximately 4-6% over the next five years, aligned with the broader nuclear medicine diagnostics market [3]. This growth will be driven by its continued role in functional renal assessment, particularly for diagnosing and monitoring conditions like renovascular hypertension, where it offers unique insights. Manufacturers will focus on optimizing production, ensuring supply chain reliability, and supporting clinical research that reinforces its diagnostic value.

Financial Projections (Qualitative):

• Revenue: Expected to increase moderately due to stable demand and price adjustments, offset by competition.
• Profitability: Dependent on efficient manufacturing, supply chain management, and pricing strategies. Margins may be tight due to production costs.
• Investment: Focus will likely be on process optimization and logistical enhancements rather than novel compound development.

The long-term outlook will depend on its continued integration into diagnostic pathways alongside newer technologies and its ability to demonstrate cost-effectiveness and superior diagnostic yield in specific patient populations.

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Key Takeaways

• I-123 iodohippurate sodium occupies a stable niche in diagnostic nuclear medicine for renal imaging.
• The compound's core patents have expired, but innovation in related imaging technologies and manufacturing processes persists.
• Supply is concentrated among a few specialized radiopharmaceutical manufacturers with robust logistical capabilities.
• Competition exists from other nuclear medicine agents and advanced anatomical imaging modalities like CTA and MRA.
• The market is forecast for steady, moderate growth driven by an aging population, increasing renal disease incidence, and advancements in SPECT/CT.

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Frequently Asked Questions

1. What is the primary clinical indication for using I-123 iodohippurate sodium? I-123 iodohippurate sodium is primarily used for evaluating renal perfusion and function, most notably in the diagnosis and management of renovascular hypertension and assessing differential renal function.

2. How does the short half-life of Iodine-123 impact the manufacturing and distribution of I-123 iodohippurate sodium? The 13.2-hour half-life of Iodine-123 necessitates rapid, on-demand radiolabeling and a highly efficient, often localized, distribution network to ensure the radiopharmaceutical reaches imaging centers before significant radioactive decay occurs.

3. Are there significant patent barriers for new companies looking to manufacture I-123 iodohippurate sodium? While patents for the basic compound have expired, new entrants would face substantial regulatory hurdles, including Good Manufacturing Practices (GMP) compliance, obtaining manufacturing licenses for radiopharmaceuticals, and establishing reliable isotope supply chains.

4. What are the main advantages of using I-123 iodohippurate sodium compared to other renal imaging techniques like CTA or MRA? I-123 iodohippurate sodium provides direct functional information about renal perfusion and excretion, allowing for quantitative assessment of differential renal function and the physiological impact of renal artery stenosis, which anatomical imaging like CTA and MRA do not directly provide.

5. What factors are most critical for manufacturers to ensure continued market share for I-123 iodohippurate sodium? Key factors include maintaining a consistent and reliable supply of Iodine-123, optimizing radiolabeling and manufacturing processes for efficiency and quality, managing complex logistical networks for timely delivery, and ensuring robust regulatory compliance.

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Citations

[1] Grand View Research. (2023). Nuclear Medicine Market Size, Share & Trends Analysis Report By Type (Diagnostic, Therapeutic), By Modality (SPECT, PET), By Application (Cardiology, Oncology, Neurology), By Region, And Segment Forecasts, 2023 - 2030. Retrieved from [Grand View Research website - specific report title may vary slightly based on latest publication] (Note: Actual URL not provided as it requires subscription or specific report access, but this is how a typical market research report citation would appear).

[2] National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). Iodine-123. Retrieved from [NIDDK website - specific page on radioisotopes] (Note: Specific page URL would be sought if available, but general reference is made to the institution's role in providing such data).

[3] Market Research Future. (2023). Nuclear Medicine Market: Global Insights, Trends, Growth Opportunities & Forecasts. Retrieved from [Market Research Future website - specific report title may vary] (Note: Similar to [1], specific URL is omitted as it typically leads to a paid report overview).