Iodohippurate sodium i-131 - Generic Drug Details

What are the generic sources for iodohippurate sodium i-131 and what is the scope of patent protection?

Iodohippurate sodium i-131 is the generic ingredient in three branded drugs marketed by Mallinckrodt, Bracco, and Pharmalucence, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Summary for iodohippurate sodium i-131

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	4
DailyMed Link:	iodohippurate sodium i-131 at DailyMed

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
Mallinckrodt	HIPPURAN I 131	iodohippurate sodium i-131	INJECTABLE;INJECTION	016666-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bracco	HIPPUTOPE	iodohippurate sodium i-131	INJECTABLE;INJECTION	015419-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharmalucence	IODOHIPPURATE SODIUM I 131	iodohippurate sodium i-131	INJECTABLE;INJECTION	017313-001	Approved Prior to Jan 1, 1982		DISCN	No	No

IODOHIPPURATE SODIUM I-131: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Iodohippurate sodium I-131, a radiopharmaceutical, is primarily utilized for renal function assessment and imaging. Its market trajectory is influenced by diagnostic procedural volumes, reimbursement policies, and the competitive landscape of alternative diagnostic methods. Patent expiries and the introduction of new therapeutic radiopharmaceuticals also shape its long-term viability.

What is the current market size and projected growth for Iodohippurate Sodium I-131?

Estimating the precise global market size for a niche radiopharmaceutical like Iodohippurate Sodium I-131 presents challenges due to limited standalone market reporting. However, its utilization is intrinsically linked to the broader nuclear medicine diagnostics market, specifically in renal scintigraphy.

The global nuclear medicine diagnostics market was valued at approximately USD 5.8 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7.4% from 2023 to 2030, reaching an estimated USD 10.3 billion by 2030. [1] Iodohippurate sodium I-131 constitutes a fraction of this market. Industry analysis suggests that the segment of radiopharmaceuticals used for diagnostic imaging, which includes agents like Iodohippurate Sodium I-131, represents a significant portion of the overall market.

Projected growth for Iodohippurate Sodium I-131 specifically is likely to mirror the growth of diagnostic procedures it supports, tempered by competition. Factors driving growth in the broader market include an increasing prevalence of chronic kidney disease, advancements in imaging technology, and rising healthcare expenditure in emerging economies. [2] Conversely, the development of more advanced imaging modalities like MRI and CT, and the emergence of novel PET-tracers for renal assessment, could moderate its growth trajectory.

What are the key applications and therapeutic areas driving demand for Iodohippurate Sodium I-131?

The primary application of Iodohippurate Sodium I-131 is in renal scintigraphy, also known as a renogram. This diagnostic procedure assesses the filtration and excretion function of the kidneys.

Key areas driving demand include:

• Diagnosis and monitoring of renal disease: This encompasses conditions such as renovascular hypertension, renal artery stenosis, and obstructive uropathy. The ability of Iodohippurate Sodium I-131 to quantify renal blood flow and tubular uptake is critical for these assessments.
• Post-surgical evaluation: Following kidney transplantation or surgical interventions for renal obstruction, Iodohippurate Sodium I-131 is used to evaluate graft function and the success of surgical repair.
• Pediatric nephrology: Its use is established in assessing renal function in children, particularly for congenital anomalies of the kidney and urinary tract.
• Differential renal function assessment: This is crucial when determining the contribution of each kidney to overall renal function, particularly in cases of unilateral renal disease or before nephrectomy.

The demand is directly correlated with the volume of these diagnostic procedures performed globally. The reliance on its ability to provide functional information, as opposed to purely anatomical imaging, underpins its continued use.

Who are the major manufacturers and suppliers of Iodohippurate Sodium I-131?

The production and supply of radiopharmaceuticals are characterized by a limited number of specialized manufacturers due to stringent regulatory requirements and the complex supply chain for radioactive isotopes.

Key entities involved in the production or distribution of Iodohippurate Sodium I-131 include:

• Cardinal Health: A significant player in the radiopharmaceutical supply chain, providing distribution and radiopharmacy services.
• Curium Pharma: A global leader in the production and distribution of radiopharmaceuticals for diagnostic imaging and therapy. They are known for their broad portfolio of diagnostic agents.
• Nordion (a division of Sotera Health): A long-standing provider of medical isotopes and radiopharmaceuticals, with a history in supplying diagnostic imaging agents.
• Other regional radiopharmacies and distributors: Numerous smaller, regional radiopharmacies play a crucial role in dispensing and preparing radiopharmaceuticals for local clinical use.

The supply chain for Iodohippurate Sodium I-131 involves sourcing of Iodine-131, a critical radioisotope. The availability and cost of Iodine-131, often derived from nuclear reactors, can directly impact the supply and pricing of the final product.

What is the patent landscape and regulatory status of Iodohippurate Sodium I-131?

Iodohippurate Sodium I-131 itself is a well-established compound, and its foundational patents have long since expired. The drug has been available for diagnostic use for several decades.

• Original Patents: The core synthesis and application patents for iodohippurate sodium I-131 expired decades ago, placing it in the public domain. This means that any manufacturer can produce the generic form of the drug, provided they meet regulatory standards.
• Manufacturing Process Patents: While the drug molecule itself is off-patent, there may be newer patents related to novel manufacturing processes, purification techniques, or specific formulations that could offer a competitive advantage to certain producers. However, these are unlikely to create a significant barrier to entry for generic manufacturers of the established product.
• Regulatory Status: Iodohippurate Sodium I-131 is approved by regulatory agencies worldwide for its intended use. In the United States, it is regulated by the Food and Drug Administration (FDA) as a radiopharmaceutical. In Europe, it falls under the purview of the European Medicines Agency (EMA) and national competent authorities. Manufacturers must adhere to Good Manufacturing Practices (GMP) and obtain specific licenses for the production and distribution of radioactive materials.

The lack of patent exclusivity for the active pharmaceutical ingredient means that competition is primarily based on manufacturing efficiency, supply chain reliability, and pricing.

What are the key market challenges and opportunities for Iodohippurate Sodium I-131?

Market Challenges:

• Competition from Alternative Imaging Modalities: Advanced MRI techniques and contrast-enhanced CT scans offer higher anatomical detail and can, in some cases, provide functional information, potentially reducing reliance on renography.
• Development of Novel Radiotracers: The nuclear medicine field is continuously evolving with the development of new PET and SPECT tracers that may offer improved sensitivity, specificity, or broader diagnostic utility in renal imaging or other applications.
• Radiation Safety Concerns and Handling: Radiopharmaceuticals require specialized handling, disposal, and personnel training due to their radioactive nature, which can add to operational costs and complexity.
• Reimbursement Policies: Changes in healthcare reimbursement policies, including shifts in coverage for diagnostic procedures or changes in payment rates for nuclear medicine scans, can directly impact the economic viability of using Iodohippurate Sodium I-131.
• Short Half-Life of Iodine-131: Iodine-131 has a half-life of approximately 8 days, necessitating timely production, distribution, and administration. This can create logistical challenges, especially for distant markets.

Market Opportunities:

• Growing Prevalence of Chronic Kidney Disease (CKD): The global rise in CKD, driven by factors like diabetes and hypertension, increases the demand for diagnostic tools to assess renal function.
• Underserved Markets: Emerging economies with expanding healthcare infrastructure may present growth opportunities for established radiopharmaceuticals like Iodohippurate Sodium I-131, where advanced imaging may be less accessible or cost-prohibitive.
• Cost-Effectiveness: Compared to some newer diagnostic technologies, Iodohippurate Sodium I-131 and the associated renography procedures can be a more cost-effective option for assessing renal function in certain clinical scenarios.
• Established Clinical Utility and Physician Familiarity: Renography using Iodohippurate Sodium I-131 is a well-established procedure with a long history of clinical use, leading to high physician familiarity and trust in its diagnostic capabilities.
• Expansion of Radiopharmacy Networks: The growth of integrated radiopharmacies and distribution networks can enhance the accessibility and efficient delivery of radiopharmaceuticals, supporting continued demand.

What is the financial trajectory and investment outlook for companies involved with Iodohippurate Sodium I-131?

The financial trajectory for companies primarily focused on manufacturing and distributing Iodohippurate Sodium I-131 is likely to be characterized by stable but modest revenue growth, influenced by the dynamics of the broader nuclear medicine diagnostics market. Given the off-patent status of the drug, profit margins are likely to be more sensitive to production costs, supply chain efficiency, and competitive pricing rather than novel intellectual property.

Companies with diversified radiopharmaceutical portfolios, including other diagnostic and therapeutic agents, are better positioned to offset potential pressures on Iodohippurate Sodium I-131. Investment outlooks for such companies will depend on their overall market position, innovation pipeline, and ability to navigate regulatory and reimbursement landscapes across their entire product range.

For pure-play manufacturers or distributors of Iodohippurate Sodium I-131, investment attractiveness will hinge on:

• Operational Efficiency: Streamlined manufacturing processes, secure sourcing of Iodine-131, and efficient logistics are paramount for maintaining profitability.
• Market Share: Securing and maintaining a significant market share within the niche of renal scintigraphy will be crucial.
• Strategic Partnerships: Collaborations with hospital networks and diagnostic centers can ensure consistent demand.
• Cost Management: Effective cost controls across production, distribution, and regulatory compliance are essential.

The investment outlook is therefore more aligned with a mature market segment rather than high-growth, disruptive technologies. Acquisitions of smaller radiopharmaceutical entities by larger players seeking to consolidate market share or expand their service offerings could occur.

Key Takeaways

• Iodohippurate Sodium I-131 is a niche radiopharmaceutical for renal scintigraphy with a market intrinsically linked to nuclear medicine diagnostics.
• Its market growth is projected to align with the broader nuclear medicine diagnostics market, estimated to reach USD 10.3 billion by 2030, but faces competition from alternative imaging modalities.
• Key applications are centered on assessing kidney function, diagnosing renal diseases, and monitoring post-surgical outcomes.
• The drug is off-patent, leading to competition based on manufacturing efficiency, supply chain reliability, and pricing, rather than intellectual property.
• Major challenges include competition from advanced imaging, evolving radiotracer technology, and regulatory hurdles, while opportunities lie in the growing prevalence of CKD and cost-effectiveness in underserved markets.
• Companies involved are likely to experience stable but modest revenue growth, with profitability dependent on operational efficiency and market share.

Frequently Asked Questions

1. What is the primary diagnostic advantage of using Iodohippurate Sodium I-131 compared to non-radioactive kidney imaging techniques? Iodohippurate Sodium I-131 provides quantitative functional information about renal blood flow and tubular secretion, which is a direct measure of kidney performance that is not fully replicated by purely anatomical imaging techniques like ultrasound or CT without contrast agents.

2. How does the short half-life of Iodine-131 impact the logistics and cost of Iodohippurate Sodium I-131? The 8-day half-life necessitates rapid production, distribution, and administration, leading to increased logistical complexity and potentially higher transportation costs to ensure product viability at the point of use.

3. Are there any emerging therapeutic applications for Iodohippurate Sodium I-131 beyond diagnostic imaging? Currently, the primary and established use of Iodohippurate Sodium I-131 is diagnostic. While radioisotopes are used therapeutically, therapeutic applications for this specific compound are not prominent in current clinical practice or research.

4. What are the specific regulatory requirements for handling and disposing of Iodohippurate Sodium I-131 in a clinical setting? Regulatory requirements are stringent and vary by jurisdiction but generally include adherence to radiation safety protocols, licensed facilities, trained personnel for handling and administration, and approved methods for radioactive waste disposal to prevent environmental contamination.

5. How does the cost of a renogram using Iodohippurate Sodium I-131 compare to a contrast-enhanced MRI of the kidneys? Generally, a renogram using Iodohippurate Sodium I-131 is considered more cost-effective than a contrast-enhanced MRI of the kidneys, particularly when the primary need is to assess functional capacity rather than detailed anatomical visualization.

Citations

[1] Grand View Research. (2023). Nuclear Medicine Diagnostics Market Size, Share & Trends Analysis Report By Type (SPECT, PET, Planar Imaging), By Application (Oncology, Cardiology, Neurology, Others), By End-use, By Region, And Segment Forecasts, 2023-2030. Grand View Research.

[2] MarketsandMarkets. (2023). Nuclear Medicine Market - Global Forecast to 2028. MarketsandMarkets.