IOBENGUANE SULFATE I-123 - Generic Drug Details

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

Iobenguane sulfate i-123 is the generic ingredient in two branded drugs marketed by Ge Healthcare and Bwxt Medcl, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for IOBENGUANE SULFATE I-123

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	4
DailyMed Link:	IOBENGUANE SULFATE I-123 at DailyMed

Recent Clinical Trials for IOBENGUANE SULFATE I-123

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
New Approaches to Neuroblastoma Therapy Consortium	Phase 1
United Therapeutics	Phase 1
National Cancer Institute (NCI)	Phase 3

See all IOBENGUANE SULFATE I-123 clinical trials

US Patents and Regulatory Information for IOBENGUANE SULFATE 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	ADREVIEW	iobenguane sulfate i-123	SOLUTION;INTRAVENOUS	022290-001	Sep 19, 2008		RX	Yes	Yes
Bwxt Medcl	IOBENGUANE I-123	iobenguane sulfate i-123	SOLUTION;INTRAVENOUS	213637-001	Dec 9, 2024		DISCN	No	No

Last updated: September 3, 2026

Iobenguane sulfate I-123, marketed in the United States as AdreView, is a mature diagnostic radiopharmaceutical with a narrow but defensible role in pheochromocytoma, paraganglioma, neuroblastoma, and selected cardiac-imaging workflows. Its commercial outlook depends more on radiopharmaceutical supply, nuclear-medicine capacity, reimbursement, and clinical substitution by PET imaging than on patent exclusivity. Product-level revenue is not separately reported by the commercial suppliers, so the financial trajectory is best characterized as stable-to-low-growth with episodic demand tied to oncology diagnosis and specialty-center utilization.

Iobenguane Sulfate I-123 Market Dynamics, Financial Trajectory, Patents, and FDA Status

What is iobenguane sulfate I-123 used for?

Iobenguane sulfate I-123 is a radioactive diagnostic agent used for targeted scintigraphic imaging. It is also known as iodine-123 metaiodobenzylguanidine, or I-123 MIBG.

In the United States, AdreView is approved for scintigraphic localization of primary or metastatic pheochromocytoma and neuroblastoma as an adjunct to other diagnostic tests. The product has also been used in cardiac sympathetic-innervation imaging, although the commercial importance of that application is smaller than the oncologic market.[1,2]

I-123 MIBG is taken up by adrenergic tissue through the norepinephrine transporter. Gamma-camera imaging and SPECT or SPECT/CT then identify abnormal tissue distribution.

Principal clinical applications

Application	Commercial role	Main alternatives
Pheochromocytoma and paraganglioma localization	Established, specialized use	CT, MRI, 18F-FDOPA PET, 68Ga-DOTATATE PET/CT, 18F-FDG PET
Neuroblastoma imaging	Important in staging, response assessment, and surveillance	FDG PET, MRI, CT
Cardiac sympathetic imaging	Niche use in selected heart-failure settings and research	Echocardiography, cardiac MRI, PET-based approaches
Theranostic selection for I-131 MIBG therapy	Helps establish MIBG avidity in appropriate patients	FDG PET and receptor-based imaging, depending on disease

I-123 has a physical half-life of approximately 13.2 hours. The short half-life reduces long-term radiation burden but creates strict production, shipping, scheduling, and administration requirements.[1]

What is the FDA status of AdreView and I-123 MIBG?

The FDA approved AdreView under NDA 022290 in 2008. The product is supplied as an intravenous injection and requires thyroid blockade to reduce uptake of free radioactive iodine.[1,3]

FDA regulatory timeline

Date	Event
2008	FDA approval of AdreView for localization of pheochromocytoma and neuroblastoma
2010s	Broader integration into nuclear-oncology and specialty imaging workflows
2018	FDA approval of Azedra, a separate I-131 iobenguane product for therapeutic use in selected patients with unresectable or metastatic pheochromocytoma or paraganglioma
2020s	Continued use of I-123 MIBG, with competition from PET-based imaging and growing concentration of care in specialty centers

AdreView is a diagnostic product. It is not interchangeable with Azedra. AdreView contains iodine-123 and is used primarily for imaging. Azedra contains iodine-131 and is a therapeutic radiopharmaceutical.

What is the Orange Book status of iobenguane sulfate I-123?

AdreView has limited conventional Orange Book protection. Its commercial position is not based on an active composition-of-matter patent estate comparable to a recently approved small-molecule drug.

The key regulatory and commercial points are:

• NDA 022290 is the relevant U.S. application for AdreView.
• The product’s original FDA approval dates to 2008.
• The five-year new chemical entity exclusivity period has expired.
• Any original clinical-data exclusivity has expired.
• No widely recognized, commercially material unexpired Orange Book patent is associated with the core I-123 iobenguane diagnostic product.
• Entry barriers arise mainly from radioactive-isotope manufacturing, quality systems, distribution, specialized handling, and demand concentration.

The absence of meaningful Orange Book protection does not mean immediate generic competition. A competing radiopharmaceutical supplier must establish an approved product, secure isotope supply, qualify manufacturing and packaging systems, and maintain dependable delivery to nuclear-medicine sites.

What patents protect iobenguane sulfate I-123?

The core molecule and diagnostic concept are mature. The practical patent position is therefore weaker than the operational barriers surrounding the product.

Patent categories potentially relevant to I-123 MIBG

Patent category	Relevance to AdreView
Active ingredient composition	Limited or expired for the mature iobenguane molecule
Radioiodination chemistry	May protect specific manufacturing methods, but broad commercial protection is unlikely to remain central
Formulation and stabilizers	Possible narrow claims; generally less important than isotope supply
Kits and packaging	Potentially relevant for handling and administration
Imaging methods	Possible method-of-use claims, but broad diagnostic claims face validity and enforceability constraints
Radiopharmaceutical manufacturing	Can create process barriers even where patent exclusivity is weak
Therapeutic MIBG use	Separate from diagnostic I-123 use and more relevant to I-131 products such as Azedra

No active patent number should be treated as the primary determinant of U.S. market access for AdreView. The relevant diligence focus is the NDA, product-specific FDA requirements, supplier agreements, isotope contracts, manufacturing licenses, and state and federal radioactive-material controls.

When does iobenguane sulfate I-123 lose exclusivity?

AdreView lost meaningful statutory exclusivity years ago. The relevant exclusivity milestones are:

Protection	Status
New chemical entity exclusivity	Expired
Orphan-drug exclusivity, if applicable to the original diagnostic indication	Expired
Pediatric exclusivity	No current commercial significance
Orange Book patent exclusivity	No widely recognized active protection central to the product
Regulatory exclusivity today	None expected to block an otherwise approvable competing product

Generic or follow-on entry would require a suitable FDA pathway and a product that meets radiopharmaceutical quality, sterility, identity, potency, radionuclidic purity, and stability requirements. The short half-life makes ordinary tablet-style generic substitution impractical. Products are likely to compete through supplier reliability and regional radiopharmacy coverage rather than only through price.

How many companies compete with AdreView?

The U.S. market is concentrated. Competition exists at three levels:

1. Direct I-123 MIBG supply.
2. Alternative MIBG products or hospital-prepared radiopharmaceutical workflows.
3. Diagnostic substitution through PET, MRI, CT, and functional imaging agents.

GE HealthCare has historically commercialized AdreView in the United States. Radiopharmaceutical production and distribution may involve affiliated manufacturing entities or external isotope and radiopharmacy partners. Jubilant Radiopharma and other nuclear-medicine suppliers participate in the broader radiopharmaceutical supply chain, but participation in the overall market does not establish direct FDA-approved substitution for AdreView.

Competitive landscape by disease

Disease area	I-123 MIBG position	Competitive pressure
Neuroblastoma	Strongest strategic role, especially where MIBG avidity affects treatment planning	PET adoption, site expertise, scanner availability
Pheochromocytoma/paraganglioma	Useful but increasingly selective	68Ga-DOTATATE, 18F-FDOPA, MRI, CT
Heart failure	Limited and specialized	Conventional cardiac diagnostics and newer imaging approaches
Therapy selection for I-131 MIBG	Clinically relevant when MIBG-avid disease is suspected	FDG PET and somatostatin-receptor imaging

The most important competitive threat is not a conventional generic. It is migration from planar scintigraphy or SPECT to PET-based imaging where PET has better resolution, shorter workflows, stronger reimbursement, or greater availability.

What formulations are protected by patents?

AdreView is supplied as an injectable solution rather than a differentiated oral or extended-release formulation. Formulation differentiation is limited.

The commercial formulation must maintain:

• Sterility.
• Chemical stability.
• Radionuclidic purity.
• Radiochemical purity.
• Appropriate specific activity.
• Consistent iodine-123 labeling.
• Acceptable intravenous administration characteristics.

Because I-123 decays rapidly, inventory management is more important than long shelf life. A product with a technically similar formulation can still fail commercially if it cannot deliver doses on the required clinical schedule.

What manufacturing and intellectual-property barriers affect entry?

Manufacturing is the principal barrier to entry.

Isotope and production constraints

I-123 supply depends on reactor or cyclotron capacity, precursor availability, radioiodination capability, release testing, and validated logistics. The product must move rapidly from production to use. A disruption at any point can cause canceled scans and loss of physician confidence.

Manufacturers also need:

• Radioactive-material licenses.
• GMP-compliant facilities.
• Validated synthesis and purification methods.
• Radiochemistry release testing.
• Qualified shipping containers.
• Radiation-safety procedures.
• Regional distribution infrastructure.
• Pharmacovigilance and batch-traceability systems.

These requirements create a higher fixed-cost burden than the patent record suggests. A new entrant may avoid patent litigation and still face substantial capital and operational risk.

What patent litigation and Paragraph IV challenges affect AdreView?

No major, publicly prominent Paragraph IV campaign has established a durable challenge to AdreView comparable to the challenges seen for high-revenue oral drugs.

The litigation risk is therefore low on a patent basis but not zero on a product basis. Potential disputes could involve:

• Radioiodination process patents.
• Product-by-process claims.
• Manufacturing know-how.
• Trade secrets involving isotope handling or release testing.
• Contractual supply arrangements.
• Regulatory exclusivity or approval-pathway disputes.
• False advertising or substitution claims involving competing imaging agents.

A Paragraph IV filing would have limited strategic value unless the challenger had secure isotope supply and a hospital distribution network. Patent clearance alone would not solve the commercial execution problem.

What is the financial trajectory for iobenguane sulfate I-123?

AdreView is a mature, niche product with limited public financial disclosure. GE HealthCare does not separately report AdreView revenue in its public segment reporting. The product’s financial trajectory is therefore inferred from market structure rather than from a disclosed product-level income statement.

Revenue drivers

The main revenue drivers are:

• Number of neuroblastoma and pheochromocytoma imaging procedures.
• Referral concentration at academic and specialty oncology centers.
• MIBG use for treatment planning.
• Reimbursement for nuclear-medicine imaging.
• Availability of PET alternatives.
• I-123 isotope cost and supply stability.
• Dose cancellation rates caused by delivery delays or patient scheduling changes.

Financial profile

Metric	Expected profile
Revenue growth	Low single digit or flat in mature markets, with regional variation
Gross margin	Potentially attractive because of specialty manufacturing and limited direct competition
Volume risk	High sensitivity to isotope availability and procedure scheduling
Price risk	Moderate; substitution and reimbursement constrain pricing
Patent erosion risk	Low because material patent protection is already limited
Operational risk	High relative to ordinary diagnostic drugs
Commercial concentration	High, with demand centered in tertiary hospitals and cancer centers

The product can retain economic value after patent expiry because reliable radiopharmaceutical delivery is difficult to replicate. That value is vulnerable to PET substitution, however. A competing imaging modality does not need to be chemically equivalent to reduce I-123 MIBG demand.

How does AdreView compare with Azedra?

Attribute	AdreView	Azedra
Active radioactive isotope	Iodine-123	Iodine-131
Primary role	Diagnostic imaging	Targeted radiotherapy
Main disease focus	Pheochromocytoma, paraganglioma, neuroblastoma	Selected unresectable or metastatic pheochromocytoma/paraganglioma
FDA approval	2008	2018
Administration	Imaging dose	Therapeutic dose with dosimetry and radiation precautions
Commercial economics	Procedure-based diagnostic revenue	Higher-value treatment episodes with more complex reimbursement
Patent and exclusivity position	Mature and largely expired	Newer product estate, but commercial execution and reimbursement remain important
Competitive threat	PET and MRI-based imaging	Other systemic therapies and treatment sequencing

Azedra can support MIBG-based clinical pathways, but it does not eliminate the need for diagnostic MIBG imaging in every case. The products have related biology but separate regulatory, clinical, and financial profiles.

What generic launch scenarios exist for I-123 MIBG?

Scenario 1: No direct generic launch

This is the most likely baseline. AdreView remains available, while PET and other imaging modalities capture incremental share. The product produces stable specialty revenue but limited growth.

Scenario 2: Regional radiopharmaceutical entrant

A competitor launches in selected geographic markets with reliable isotope access. Pricing pressure develops locally, but national displacement remains limited because nuclear-medicine sites value supply continuity.

Scenario 3: Broad U.S. follow-on competition

A second approved I-123 MIBG product gains wide distribution. This would reduce pricing power and could increase contracting pressure from hospitals and radiopharmacies. The entrant would still need dependable daily or scheduled dose delivery.

Scenario 4: Accelerated modality substitution

PET agents, especially 68Ga-DOTATATE and 18F-FDOPA where clinically appropriate, take share from I-123 MIBG. The impact would be greatest in adult pheochromocytoma and paraganglioma. Neuroblastoma demand may prove more resilient because MIBG remains embedded in pediatric oncology workflows and therapy-selection protocols.[4,5]

What is the geographic coverage of the I-123 MIBG market?

The United States, Europe, and Japan have established nuclear-medicine infrastructure, but product availability differs by country. The market is strongest where there are:

• High-volume oncology centers.
• Pediatric neuroblastoma programs.
• Endocrine oncology referral networks.
• Radiopharmacies with scheduled isotope delivery.
• Reimbursement for SPECT/CT and specialty imaging.

Emerging markets may have clinical demand but weaker commercial access because of limited isotope production, fewer nuclear-medicine cameras, and lower reimbursement. Geographic expansion is therefore constrained by infrastructure rather than by unmet clinical awareness alone.

Key Takeaways

• Iobenguane sulfate I-123 is a mature diagnostic radiopharmaceutical marketed in the United States as AdreView.
• The FDA approved AdreView in 2008 under NDA 022290.
• Core statutory exclusivity has expired, and patent protection is not the principal commercial barrier.
• No major Paragraph IV or patent-litigation campaign currently defines the product’s market.
• Manufacturing, isotope availability, radiopharmacy logistics, and regulatory compliance protect the incumbent more than patents do.
• Neuroblastoma is the most defensible clinical segment.
• Pheochromocytoma and paraganglioma imaging face increasing competition from PET agents, particularly 68Ga-DOTATATE and 18F-FDOPA.
• Product-level revenue is not separately disclosed by the commercial supplier.
• The likely financial profile is stable-to-low-growth specialty revenue, with downside from PET substitution and upside from continued use in high-volume oncology centers.
• Azedra, the I-131 therapeutic product, is commercially and legally distinct from diagnostic I-123 MIBG.

FAQs About Iobenguane Sulfate I-123

Is iobenguane I-123 the same as MIBG?

Yes. Iobenguane I-123 is the radioactive iodine-123 form of metaiodobenzylguanidine, commonly called I-123 MIBG.

Is AdreView still commercially available?

AdreView has been marketed as a U.S. diagnostic radiopharmaceutical. Availability depends on manufacturing schedules, isotope supply, radiopharmacy distribution, and local nuclear-medicine demand.

Can 68Ga-DOTATATE replace I-123 MIBG?

It can replace I-123 MIBG in selected adult pheochromocytoma and paraganglioma workflows, but the agents are not universally interchangeable. Disease biology, treatment planning, institutional protocols, and regulatory labeling determine the appropriate test.

Does I-123 MIBG have biosimilar risk?

No. Biosimilar rules apply to biological products. I-123 MIBG is a radiolabeled small-molecule diagnostic drug. Its competitive risk comes from generic-style radiopharmaceutical entry and alternative imaging modalities.

Is I-123 MIBG used to select patients for Azedra?

MIBG avidity is clinically relevant to I-131 MIBG therapy selection, but the exact imaging and treatment pathway depends on the approved product labeling, disease status, and treating-center protocol.

References

1. U.S. Food and Drug Administration. (2023). AdreView (iobenguane sulfate I 123 injection) prescribing information.
2. U.S. Food and Drug Administration. (2008). Drugs@FDA: AdreView, NDA 022290.
3. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations.
4. National Comprehensive Cancer Network. (2024). NCCN Clinical Practice Guidelines in Oncology: Neuroblastoma.
5. National Comprehensive Cancer Network. (2024). NCCN Clinical Practice Guidelines in Oncology: Neuroendocrine and adrenal tumors.
6. U.S. Food and Drug Administration. (2018). Azedra (iobenguane I 131) prescribing information.