IOBENGUANE I-123 Drug Patent Profile

When do Iobenguane I-123 patents expire, and when can generic versions of Iobenguane I-123 launch?

Iobenguane I-123 is a drug marketed by Bwxt Medcl and is included in one NDA.

The generic ingredient in IOBENGUANE I-123 is iobenguane sulfate i-123. One supplier is listed for this compound. Additional details are available on the iobenguane sulfate i-123 profile page.

Summary for IOBENGUANE I-123

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for IOBENGUANE I-123

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bwxt Medcl	IOBENGUANE I-123	iobenguane sulfate i-123	SOLUTION;INTRAVENOUS	213637-001	Dec 9, 2024		DISCN	No	No

Investment Scenario and Fundamentals Analysis for IOBENGUANE I-123

Last updated: March 5, 2026

What is IOBENGUANE I-123?

IOBENGUANE I-123 is a radiopharmaceutical used in diagnostic imaging, specifically for neuroendocrine tumor detection via single-photon emission computed tomography (SPECT). It is a specialty compound, leveraging the radioactive isotope Iodine-123 (I-123), with applications in nuclear medicine for precise tumor localization.

Regulatory and Market Context

Regulatory Status

• Approved by the U.S. Food and Drug Administration (FDA) for diagnostic use.
• Similar approvals in European Medicines Agency (EMA) jurisdictions.
• Subject to strict manufacturing protocols due to radioisotope handling requirements.
• Ongoing efforts to expand indications, including potential use in imaging other neuroendocrine tumors.

Market Dynamics

• The global molecular imaging market exceeded USD 7 billion in 2022, with radiotracers comprising a significant segment.
• Diagnostic nuclear imaging is forecasted to grow at a compound annual growth rate (CAGR) of 7% through 2030.
• Specific demand driven by increased prevalence of neuroendocrine tumors, estimated at 200,000 cases globally annually.
• Incidences are rising, particularly in developed markets, due to improved detection capabilities.

Competitive Landscape

• Key competitors include Octreoscan (Indium-111 labeled octreotide) and newer PET-based tracers like Gallium-68 DOTATATE.
• IOBENGUANE I-123’s relevance centers on global availability and ease of use in existing SPECT infrastructure.
• The limited number of radiopharmaceuticals approved for neuroendocrine tumor imaging sustains its niche but also imposes regulatory and manufacturing hurdles.

Production and Supply Chain Fundamentals

• I-123 has a half-life of 13.2 hours, requiring a tightly integrated supply chain for timely distribution.
• Production involves cyclotron irradiation of enriched tellurium-124 targets, demanding high capital investment.
• Decay during transportation limits geographical spread; thus, centralized production hubs are common.
• Strict compliance with radiation safety standards influences manufacturing costs, which are higher than stable isotopes.

Investment Considerations

Market Entry and Adoption

• Steady adoption in developed markets driven by clinical guidelines endorsing nuclear imaging for neuroendocrine tumors.
• Limited international supply options. Expansion possible with partnerships or increased manufacturing capacity.
• Adoption barriers include high costs and the need for specialized equipment and personnel.

Patent and Regulatory Exclusivity

• Patent status varies; some formulations may benefit from exclusivity for 10-15 years.
• Regulatory pathways are robust but require extensive clinical trials, particularly for expanded indications.
• Market entry is feasible in regions with existing nuclear medicine infrastructure.

Financial Viability and Forecasts

• Manufacturing costs are high, partly due to cyclotron operations and radiopharmaceutical purification.
• Reimbursement levels for nuclear diagnostics influence profitability.
• Entry into partnership arrangements with hospital networks and radiopharmacies enhances revenue potential.

Risks and Barriers

• Regulatory delays owing to stringent approval processes.
• Short-lived isotopes increase logistical complexity.
• Competition from PET tracers with longer shelf lives and higher sensitivity.

Key Metrics for Investment Evaluation

Metric	Value	Relevance
Market Size	USD 7 billion (2022)	Overall size of nuclear imaging market
CAGR	7% (2022–2030)	Projected growth in molecular imaging
Neuroendocrine Tumor Incidence	200,000/year (globally)	Potential target patient pool
I-123 Half-life	13.2 hours	Impacts logistics and distribution

Investment Outlook

• The niche status of IOBENGUANE I-123 offers limited near-term upside but stable long-term demand, driven by case prevalence and clinical adoption.
• High manufacturing and logistics costs pose barriers but also create entry barriers that could protect early investors.
• Advancements in alternative imaging modalities or radiotracers may threaten its market share.

Key Takeaways

• IOBENGUANE I-123 occupies a specialized segment within the nuclear imaging field, with steady demand linked to neuroendocrine tumor diagnosis.
• Market growth aligns with broader trends in molecular imaging but is constrained by logistical and regulatory challenges.
• Investment opportunities hinge on expanding production capacity, regulatory navigation, and establishing supply chain efficiencies.
• Competition from PET-based tracers presents a long-term threat but also opportunities if the compound demonstrates safety and cost advantages.

FAQs

1. What are the main advantages of IOBENGUANE I-123 over alternative tracers?
   It has wider global availability, existing infrastructure for SPECT imaging, and established regulatory approvals.

2. What are the primary risks associated with investing in IOBENGUANE I-123?
   Regulatory delays, logistical challenges due to isotope decay, and competition from PET-based tracers.

3. How does the short half-life of I-123 impact the supply chain?
   It limits distribution radius and necessitates nearby production facilities, increasing manufacturing costs.

4. What is the potential for market expansion in emerging regions?
   Opportunities exist with infrastructure development and regulatory approvals but require significant initial investments.

5. Which partnerships are vital for commercializing IOBENGUANE I-123?
   Collaborations with radiopharmaceutical manufacturers, nuclear medicine providers, and hospital networks are key.

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References

[1] PubChem. (2022). Iodine-123. National Center for Biotechnology Information.
[2] MarketsandMarkets. (2022). Molecular Imaging Market report.
[3] U.S. FDA. (2022). Approved Radiopharmaceuticals.
[4] European Medicines Agency. (2022). Market authorizations for radiopharmaceuticals.