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

# Iodohippurate Sodium I-123 Market Dynamics, Financial Trajectory, Patents, and FDA Status

Last updated: September 19, 2026

Iodohippurate sodium I-123 is a short-lived renal diagnostic radiopharmaceutical used for dynamic kidney imaging and assessment of renal perfusion, function, and urinary excretion. Its commercial market is small, specialized, and supply-driven. The product has limited direct competition from other radiopharmaceuticals, but technetium-99m-based renal agents, ultrasound, CT, MRI, and laboratory testing constrain demand.

Public companies generally do not report revenue for iodohippurate sodium I-123 separately. The financial outlook therefore depends on procedure volume, radiopharmacy distribution, isotope availability, hospital purchasing, reimbursement, and the migration of renal imaging toward technetium-based agents and non-nuclear modalities.

What is iodohippurate sodium I-123 used for?

Iodohippurate sodium I-123 is an intravenous radioactive diagnostic agent used to evaluate renal blood flow and renal function. The compound is handled by the kidneys and excreted into urine, allowing sequential imaging of renal uptake, transit, and clearance.

Attribute	Description
Active ingredient	Iodohippurate sodium labeled with iodine-123
Therapeutic category	Diagnostic radiopharmaceutical
Primary application	Renal imaging and functional assessment
Administration	Intravenous injection
Radiation type	Gamma emission
Principal photon energy	Approximately 159 keV
Physical half-life	Approximately 13.2 hours
Typical supply model	Central radiopharmacy or nuclear medicine distributor
Prescription status	Prescription diagnostic product
Therapeutic effect	None; used for diagnostic imaging

Iodine-123 has a shorter half-life and more favorable imaging characteristics than iodine-131 for diagnostic use. The short half-life limits inventory holding and requires delivery close to the scheduled procedure.

How does iodohippurate sodium I-123 work in renal imaging?

After intravenous administration, iodohippurate is rapidly extracted from the blood by the kidneys and cleared into the urine. Sequential imaging can generate information on renal perfusion, relative kidney function, and urinary drainage.

The agent historically supported renography and renal clearance studies. Its role has narrowed as technetium-99m compounds, especially technetium Tc-99m mertiatide, have become widely used for renal scintigraphy. Iodohippurate sodium I-123 remains technically relevant where facilities have established protocols, isotope access, or specific clinical preferences.

The product's clinical value is concentrated in nuclear medicine departments with:

• Existing gamma-camera capacity.
• Radiopharmacy handling capability.
• Established renal imaging protocols.
• Access to iodine-123 supply.
• Reimbursement for nuclear renal studies.

What is the FDA regulatory status of iodohippurate sodium I-123?

Iodohippurate sodium I-123 is regulated as a prescription radiopharmaceutical diagnostic agent. Product labeling describes renal imaging use, intravenous administration, radiation precautions, pregnancy considerations, and adverse reactions associated with radioactive diagnostic products.[1]

The regulatory pathway is different from that of an ordinary small-molecule medicine. Commercial value depends on a combination of:

1. FDA approval of the drug product.
2. Radioactive-material licensing.
3. Facility-level compliance with federal and state radiation rules.
4. Manufacturing controls for sterile injectable products.
5. Reliable isotope procurement and distribution.

Radiopharmacies and hospitals must comply with applicable U.S. Nuclear Regulatory Commission or Agreement State requirements for possession and handling of radioactive materials.[2]

What is the Orange Book status of iodohippurate sodium I-123?

A product-specific Orange Book patent position is not a central commercial barrier for iodohippurate sodium I-123. The active ingredient and its renal diagnostic use are longstanding, and any original composition or use patents would generally have expired.

The principal barriers are operational rather than exclusivity-based:

• FDA-approved manufacturing capacity.
• Radioactive iodine-123 procurement.
• Sterile injectable production.
• Short shelf life.
• Distribution timing.
• Radiopharmacy licensing.
• Hospital protocol adoption.

The product should therefore be analyzed as a mature, low-volume diagnostic radiopharmaceutical rather than as a patent-protected growth medicine.

What patents protect iodohippurate sodium I-123?

No material, currently enforceable patent moat is apparent from the product's long market history and established use as a renal imaging agent. The commercially relevant intellectual-property categories are more likely to involve:

IP category	Current commercial relevance
Iodohippurate compound patents	Low; likely expired
I-123 labeling or imaging methods	Low to moderate, depending on claim scope and age
Formulation patents	Low for a conventional injectable solution
Manufacturing processes	Moderate if they improve radiochemical purity, sterility, or yield
Device or imaging software patents	Separate from the drug product
Trade secrets	Potentially relevant to production and quality control
Distribution know-how	Operational value, not conventional patent exclusivity

What formulations are protected by iodohippurate sodium I-123 patents?

The commercially relevant formulation is a sterile injectable solution containing iodohippurate sodium labeled with iodine-123. Its value does not appear to depend on a modern extended-release, depot, liposomal, or device-enabled formulation.

Potential formulation barriers include:

• Radiochemical purity specifications.
• Sterility assurance.
• Stabilizer selection.
• Control of free iodine.
• Container closure integrity.
• Lot release testing.
• Calibration and expiry dating.

These requirements can make market entry expensive even without enforceable formulation patents. A new supplier must produce a reliable product with a commercially useful expiry window despite the 13.2-hour physical half-life of iodine-123.

When does iodohippurate sodium I-123 lose exclusivity?

The product's meaningful regulatory and patent exclusivity has already elapsed or is not commercially significant. The market is therefore open to approved competitors, subject to FDA requirements and radioactive-material controls.

There is no typical branded-drug exclusivity cliff comparable to a major oral medicine. Generic entry would not necessarily cause a sudden revenue collapse because:

• The existing market is already mature.
• The product is administered in specialized facilities.
• Supply reliability often matters more than brand identity.
• Purchasing decisions are influenced by isotope availability and delivery schedules.
• Substitution with technetium-based renal agents is already possible.

How many companies manufacture or distribute iodohippurate sodium I-123?

The market is served through a narrow network of radiopharmaceutical manufacturers, radiopharmacies, specialty distributors, and hospital nuclear medicine departments. Public disclosures do not provide a reliable product-specific count of active manufacturers or annual unit sales.

The supply chain typically includes:

1. Production or procurement of iodine-123.
2. Radiolabeling of iodohippurate.
3. Sterile release testing.
4. Calibration for a specified time.
5. Shipment to hospitals or imaging centers.
6. Administration within the usable activity window.

This model favors suppliers with established nuclear medicine infrastructure. A conventional pharmaceutical company without radioisotope logistics would face significant entry costs.

What drives the market for iodohippurate sodium I-123?

The market is driven by procedure demand rather than chronic prescription volume.

Renal imaging utilization

Demand depends on the number of renal function studies ordered by nephrologists, urologists, transplant centers, pediatric specialists, and nuclear medicine physicians. Utilization is affected by kidney disease prevalence, transplant monitoring, obstruction evaluation, and institutional protocol preferences.

Competition from technetium-99m agents

Technetium Tc-99m mertiatide and other technetium-based products are the primary nuclear medicine alternatives. They benefit from broad nuclear medicine infrastructure and established reimbursement pathways.

A facility that already has technetium-99m access may prefer a technetium renal agent because it can simplify scheduling, procurement, and staff workflows.

Competition from non-nuclear imaging

Ultrasound, CT urography, MRI, and laboratory measures of renal function limit the addressable market. These technologies do not replicate every functional measurement provided by dynamic renal scintigraphy, but they can replace nuclear testing in selected clinical pathways.

Isotope logistics

Iodine-123's short half-life creates a direct link between supply reliability and revenue. A delayed shipment can result in a missed procedure and product loss. Suppliers with local or regional distribution networks have an advantage over distant manufacturers.

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

The product's financial trajectory is likely mature to declining in unit volume, with revenue stability depending on pricing, supply continuity, and institutional retention.

Financial driver	Expected effect
Higher renal imaging volume	Positive
Price increases in a constrained supply market	Positive revenue effect
Shift to technetium renal agents	Negative
Growth of non-nuclear imaging	Negative
Radioisotope shortages	Negative volume effect
Hospital budget pressure	Negative pricing effect
New radiopharmacy capacity	Negative for incumbent pricing
Manufacturing disruption	Negative and potentially severe
Expanded transplant or pediatric use	Positive but limited

Product-level sales are generally not separated in public financial statements. Large radiopharmaceutical companies report broader diagnostic portfolios, while independent radiopharmacies may be privately held. Revenue exposure is therefore best assessed through the supplier's overall nuclear medicine portfolio, production capacity, and geographic distribution rather than through reported iodohippurate sales.

The product is unlikely to be a material revenue driver for a diversified pharmaceutical company. It can have greater importance for a specialty radiopharmacy because each product contributes to route density, customer retention, and capacity utilization.

Which companies are challenging iodohippurate sodium I-123?

Competition is primarily product-based rather than litigation-based. The relevant alternatives include suppliers of:

• Technetium Tc-99m mertiatide.
• Technetium Tc-99m pentetate.
• Other renal scintigraphy agents.
• Ultrasound and CT imaging systems.
• MRI-based renal assessment technologies.

No high-profile Paragraph IV litigation or major patent dispute is associated with iodohippurate sodium I-123 in the public record commonly used for branded pharmaceutical analysis. The absence of litigation is consistent with an old diagnostic product with limited patent value.

What patent litigation affects iodohippurate sodium I-123?

No material active patent litigation is evident as a major market factor. Litigation risk is more likely to arise from:

• FDA approval disputes.
• Manufacturing compliance.
• Sterility failures.
• Radioactive-material licensing.
• Supply contracts.
• Product liability claims.
• Reimbursement disputes.

These risks can affect commercial availability without creating traditional patent exclusivity.

What generic launch risks exist for iodohippurate sodium I-123?

A new entrant would face moderate operational risk and low conventional patent risk.

Key entry barriers

• Access to iodine-123.
• Radiolabeling expertise.
• Sterile injectable manufacturing.
• Rapid batch release.
• Validated radiochemical testing.
• Nuclear pharmacy distribution.
• Facility licensing.
• Hospital formulary acceptance.
• Reimbursement and contracting.

A launch could occur without a major legal challenge if no blocking patent remains. The main commercial question would be whether the entrant can maintain enough order density to offset isotope, manufacturing, and delivery costs.

How does iodohippurate sodium I-123 compare with technetium Tc-99m mertiatide?

Factor	Iodohippurate sodium I-123	Technetium Tc-99m mertiatide
Main use	Renal imaging	Renal imaging
Isotope	Iodine-123	Technetium-99m
Half-life	About 13.2 hours	About 6 hours
Commercial position	Mature, specialized	More broadly established
Supply model	Requires iodine-123 access	Uses technetium generator or centralized supply
Competition	Narrower use base	Stronger standard-of-care competition
Patent relevance	Limited	Product-specific history may be more relevant
Revenue outlook	Stable to declining niche	Larger renal nuclear medicine opportunity

Technetium-based agents generally have stronger installed-base support. Iodohippurate sodium I-123 can remain commercially viable where clinical protocols, availability, or local economics favor it.

What is the geographic coverage of iodohippurate sodium I-123?

Commercial availability is concentrated in markets with developed nuclear medicine infrastructure and regulated radiopharmaceutical distribution. The United States is the most important reference market because of its hospital nuclear medicine base, FDA framework, radiopharmacy network, and reimbursement system.

International demand depends on:

• National approval status.
• Local isotope production.
• Radiopharmacy density.
• Nuclear medicine procedure volume.
• Reimbursement.
• Import and transport rules for radioactive products.

The short half-life makes cross-border trade more difficult than for conventional pharmaceuticals. Regional manufacturing and distribution are commercially preferable.

Key Takeaways

• Iodohippurate sodium I-123 is a mature renal diagnostic radiopharmaceutical.
• Its market is niche, procedure-driven, and dependent on radiopharmacy logistics.
• Patent exclusivity is not the principal commercial issue.
• No material Orange Book or Paragraph IV-driven market event is central to the product's outlook.
• Technetium Tc-99m renal agents are the main nuclear medicine competitors.
• Ultrasound, CT, MRI, and laboratory testing limit long-term demand.
• Product-specific revenue is not separately disclosed by major public companies.
• Financial performance depends on isotope access, manufacturing reliability, pricing, and institutional protocol retention.
• New entrants face operational and regulatory barriers despite limited patent risk.
• The likely long-term trajectory is mature to declining volume with possible revenue resilience from pricing and supply constraints.

FAQs About Iodohippurate Sodium I-123

Is iodohippurate sodium I-123 a therapeutic drug?

No. It is a diagnostic radiopharmaceutical used to evaluate renal perfusion, uptake, and excretion.

Does iodohippurate sodium I-123 have biosimilar competition?

No. Biosimilar regulation applies to biological products. Iodohippurate sodium I-123 is a chemically defined radioactive diagnostic agent.

Is iodohippurate sodium I-123 listed in the FDA Orange Book?

Its commercial position is not centered on Orange Book patent listings. The product is an old diagnostic radiopharmaceutical with limited apparent patent-based exclusivity.

Can technetium Tc-99m replace iodohippurate sodium I-123?

In many renal imaging protocols, technetium-based agents are practical alternatives. Replacement depends on the clinical question, facility protocol, isotope supply, reimbursement, and physician preference.

Why is iodohippurate sodium I-123 difficult to distribute?

Iodine-123 decays rapidly, with a physical half-life of about 13.2 hours. The product must be manufactured, tested, calibrated, shipped, and administered within a constrained period.

References

1. U.S. Food and Drug Administration. (n.d.). "Iodohippurate sodium I-123 injection" prescribing information. FDA drug labeling resources.

2. U.S. Nuclear Regulatory Commission. (n.d.). Medical use of radioactive materials and radiopharmaceutical licensing requirements. https://www.nrc.gov

3. National Library of Medicine. (n.d.). "Iodohippurate sodium I-123 injection." DailyMed. https://dailymed.nlm.nih.gov

4. International Atomic Energy Agency. (2018). Nuclear medicine resources manual. Vienna, Austria: IAEA.

5. U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations. Washington, DC: FDA.