INDIUM IN-111 PENTETREOTIDE KIT - Generic Drug Details

What are the generic drug sources for indium in-111 pentetreotide kit and what is the scope of patent protection?

Indium in-111 pentetreotide kit is the generic ingredient in two branded drugs marketed by Sun Pharm Inds Inc and Curium, 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 INDIUM IN-111 PENTETREOTIDE KIT

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Patent Applications:	111
DailyMed Link:	INDIUM IN-111 PENTETREOTIDE KIT at DailyMed

Recent Clinical Trials for INDIUM IN-111 PENTETREOTIDE KIT

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

Sponsor	Phase
University Hospital, Basel, Switzerland	Phase 1/Phase 2
University of Lausanne Hospitals	Phase 1/Phase 2
SWAN Isotopen AG, Bern	Phase 1/Phase 2

See all INDIUM IN-111 PENTETREOTIDE KIT clinical trials

US Patents and Regulatory Information for INDIUM IN-111 PENTETREOTIDE KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Curium	OCTREOSCAN	indium in-111 pentetreotide kit	INJECTABLE;INJECTION	020314-001	Jun 2, 1994		RX	Yes	Yes
Sun Pharm Inds Inc	INDIUM IN-111 PENTETREOTIDE KIT	indium in-111 pentetreotide kit	INJECTABLE;INJECTION	212785-001	Jul 1, 2024		DISCN	No	No

Expired US Patents for INDIUM IN-111 PENTETREOTIDE KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Curium	OCTREOSCAN	indium in-111 pentetreotide kit	INJECTABLE;INJECTION	020314-001	Jun 2, 1994
Curium	OCTREOSCAN	indium in-111 pentetreotide kit	INJECTABLE;INJECTION	020314-001	Jun 2, 1994
Curium	OCTREOSCAN	indium in-111 pentetreotide kit	INJECTABLE;INJECTION	020314-001	Jun 2, 1994
Curium	OCTREOSCAN	indium in-111 pentetreotide kit	INJECTABLE;INJECTION	020314-001	Jun 2, 1994

Indium In-111 Pentetreotide Kit Market Dynamics and Financial Trajectory

Last updated: September 2, 2026

Indium In-111 pentetreotide, marketed primarily as OctreoScan, is a mature diagnostic radiopharmaceutical used to localize somatostatin-receptor-positive neuroendocrine tumors. Its commercial position has weakened as gallium-68 and copper-64 somatostatin-receptor PET agents offer higher-resolution imaging, faster workflows, and stronger integration with modern neuroendocrine tumor management. The product retains a niche where PET access is limited, reimbursement favors established scintigraphy, or clinicians require a legacy imaging option.

Public financial disclosures do not report standalone revenue for OctreoScan or indium In-111 pentetreotide. The product is part of a broader nuclear-medicine portfolio, and its financial trajectory is best characterized as mature, declining, and operationally specialized rather than growth-oriented.

What is indium In-111 pentetreotide and how is it used?

Indium In-111 pentetreotide is a radiolabeled somatostatin analog. After intravenous administration, the agent binds primarily to somatostatin receptor subtype 2 and allows planar scintigraphy or SPECT imaging of receptor-positive tumors.

The product is supplied as a kit. The radiolabeling process generally requires preparation with indium In-111 chloride at a nuclear pharmacy or hospital radiopharmacy. The finished product has a physical half-life of approximately 2.8 days. Imaging commonly occurs at several hours after administration and again at approximately 24 hours, depending on institutional protocol and the clinical question.

The FDA-approved use is localization of primary and metastatic somatostatin-receptor-positive neuroendocrine tumors as an adjunct to conventional imaging and clinical evaluation.[1]

Product and regulatory profile

Attribute	Indium In-111 pentetreotide
Principal brand	OctreoScan
Active imaging agent	Indium In-111 pentetreotide
Dosage form	Kit for radiolabeling and intravenous administration
Primary use	Localization of somatostatin-receptor-positive neuroendocrine tumors
Imaging modality	Planar scintigraphy and SPECT
FDA approval	1994
FDA application	NDA 019793
Commercial sponsor listed in recent labeling	Curium US LLC
Physical half-life	Approximately 2.8 days
Medicare product code	A9542
Commercial maturity	Long-established, post-exclusivity product

OctreoScan does not treat neuroendocrine tumors. Its value is diagnostic and staging-related. That distinction limits pricing power compared with therapeutic radiopharmaceuticals such as lutetium-177 dotatate.

When did indium In-111 pentetreotide lose exclusivity?

Indium In-111 pentetreotide lost meaningful market exclusivity many years ago. The FDA approval dates to 1994, and the product has no modern exclusivity period protecting it from competition.

The active pharmaceutical concept is based on an established peptide and a diagnostic radionuclide. The commercial barriers are therefore less dependent on composition-of-matter protection and more dependent on manufacturing controls, radionuclide supply, radiochemistry, distribution, site handling, and regulatory compliance.

Exclusivity timeline

Milestone	Date or status
FDA approval of OctreoScan	1994
New chemical entity exclusivity	Expired
Original patent-based exclusivity	Expired or commercially immaterial
Current market protection	Operational and regulatory barriers
Current competitive exposure	High from SSTR PET products
Biosimilar framework	Not applicable

The product is a small-molecule radiopharmaceutical kit rather than a biologic. Biosimilar risk is therefore irrelevant. The relevant competitive risks are generic or follow-on radiopharmaceutical products, 505(b)(2) products, and direct substitution by newer PET tracers.

What patents protect indium In-111 pentetreotide?

The commercial patent estate for indium In-111 pentetreotide is weak relative to newer branded radiopharmaceuticals. The underlying peptide, pentetreotide, and the use of indium-111 for somatostatin-receptor imaging have long histories predating the current commercial market.

No active, product-defining Orange Book patent protection is generally associated with OctreoScan’s current market position. The product’s durability comes from manufacturing know-how, validated radiolabeling procedures, quality systems, radionuclide procurement, and hospital logistics.

What formulation patents cover the product?

The main formulation is a radiolabeling kit containing the peptide, stabilizing components, buffering agents, and other excipients needed to prepare the injectable radiopharmaceutical with indium In-111 chloride. Any historical formulation or kit patents would be old relative to the product’s 1994 approval and would not provide a meaningful long-term barrier today.

Potentially relevant intellectual property can exist around:

• Peptide synthesis and purification
• Chelation and radiolabeling chemistry
• Kit composition and stability
• Quality-control assays
• Manufacturing processes
• Packaging and radiopharmaceutical handling
• Imaging protocols and clinical applications

These rights do not necessarily create an enforceable commercial moat around the approved product. Product-specific patent status must be assessed in the relevant jurisdiction and against the exact formulation and manufacturing process.

Are there method-of-use patents for indium In-111 pentetreotide?

Method-of-use patents may cover particular tumor types, imaging protocols, receptor-targeting applications, or combinations with other diagnostic procedures. Such patents are unlikely to control the broad historical indication for tumor localization because the approved use has been established for decades.

Method-of-use protection can still matter in a narrow litigation or licensing context, but it is unlikely to prevent broad substitution by other somatostatin-receptor imaging agents.

What is the Orange Book status of OctreoScan?

OctreoScan is an old NDA product with no commercially significant remaining exclusivity. The key FDA regulatory asset is the approved NDA, not a live patent estate.

The Orange Book generally functions as the principal reference for small-molecule drug patents and approved products. For an older radiopharmaceutical kit, the practical competitive question is whether a follow-on applicant can obtain approval through an ANDA or a 505(b)(2) pathway and whether the sponsor can maintain reliable supply.

What Paragraph IV challenges are likely?

A conventional Paragraph IV challenge is unlikely to be the primary threat to OctreoScan. The product’s market is limited, the reference product is mature, and direct generic development may not generate sufficient returns to support an aggressive patent challenge.

A follow-on applicant could instead pursue:

• An ANDA, if the FDA determines that the product can be adequately demonstrated to be therapeutically equivalent;
• A 505(b)(2) application using the existing safety and efficacy record;
• A new NDA for a differentiated radiolabeled somatostatin analog;
• A PET agent development program that competes clinically rather than through direct substitution.

The most serious commercial challenge does not require a Paragraph IV filing. It comes from FDA-approved PET agents that move physicians, hospitals, and payers away from In-111 scintigraphy.

How does indium In-111 pentetreotide compare with newer somatostatin-receptor imaging agents?

Gallium-68 and copper-64 PET agents have become the principal competitive alternatives in somatostatin-receptor imaging. FDA-approved products include Ga-68 dotatate, marketed as Netspot, Ga-68 gozetotide, marketed as Illuccix, and Cu-64 dotatate, marketed as Detectnet.[2-4]

Product	Radionuclide	Modality	Commercial position
OctreoScan	In-111	Planar imaging/SPECT	Mature legacy product
Netspot	Ga-68	PET/CT	Established SSTR PET alternative
Illuccix	Ga-68	PET/CT	Established SSTR PET alternative
Detectnet	Cu-64	PET/CT	Longer-lived PET alternative

Why PET is displacing In-111 imaging

PET products generally offer:

• Higher spatial resolution
• Better lesion detection
• Shorter imaging workflows
• More favorable whole-body assessment
• Easier integration with current oncology imaging infrastructure
• Stronger alignment with neuroendocrine tumor treatment selection

In-111 imaging retains several practical advantages. It can be used in hospitals without an on-site PET program, its workflow is familiar to nuclear-medicine departments, and its procurement chain is established. In-111 products may also remain useful in regions where Ga-68 or Cu-64 supply is constrained.

The competitive shift is therefore gradual rather than instantaneous. Replacement depends on PET scanner capacity, radiotracer availability, payer policy, physician preference, and local radiopharmacy infrastructure.

What is the market size and financial trajectory for OctreoScan?

Standalone global sales for OctreoScan are not publicly disclosed. Curium is privately held, and product-level revenue is not separately reported in publicly available financial materials.

The financial trajectory can be inferred from market structure:

1. The product has no meaningful exclusivity protection.
2. The indication is mature.
3. Newer PET tracers have captured the premium diagnostic segment.
4. The product requires specialized radiopharmacy handling.
5. Its demand is geographically uneven.
6. Revenue is likely concentrated in hospitals, imaging centers, and nuclear-medicine distributors.

Revenue trajectory

Period	Likely commercial condition
1990s to early 2000s	Core somatostatin-receptor imaging product
2010s	Increasing pressure from PET adoption and improved cross-sectional imaging
Late 2010s to early 2020s	Continued use in sites without PET access; declining strategic importance
Current mature phase	Niche, supply-dependent product with limited pricing expansion

The product may remain profitable at the contribution-margin level even if total revenue declines. Mature radiopharmaceuticals can generate cash flow when manufacturing assets, regulatory approvals, and distribution channels are already in place. Their economics depend heavily on batch utilization, radionuclide costs, production reliability, and waste management.

What factors determine the price and profitability of indium In-111 pentetreotide?

OctreoScan pricing is influenced less by intellectual-property protection than by supply-chain economics.

Principal cost drivers

• Indium In-111 procurement
• Peptide and kit-component manufacturing
• Radiolabeling and quality-control operations
• Short product dating and inventory losses
• Specialized shipping
• Nuclear pharmacy labor
• Regulatory compliance
• Radiation-safety infrastructure
• Hospital administration and reimbursement

Radiopharmaceutical manufacturers must balance production against predictable demand. Unused units can become unusable as radioactivity decays, creating inventory risk that is not present with conventional oral drugs.

The product’s financial profile is therefore sensitive to order density. A supplier serving a concentrated network of hospitals can operate more efficiently than a supplier serving fragmented, low-volume demand.

What reimbursement supports indium In-111 pentetreotide?

In the United States, Medicare identifies indium In-111 pentetreotide under HCPCS code A9542. Reimbursement also depends on the associated imaging procedure, site of care, payer contract, medical necessity rules, and local coverage policy.[5]

Reimbursement pressure is likely to increase as payers compare In-111 scintigraphy with PET alternatives. A lower unit acquisition cost does not guarantee economic advantage if the imaging pathway requires more time, delayed imaging, repeat visits, or produces less clinically useful information.

PET reimbursement and coverage expansion can accelerate the shift away from In-111 products. In contrast, access limitations, scanner capacity constraints, and regional radiotracer shortages preserve demand for OctreoScan.

Which companies are challenging indium In-111 pentetreotide?

The main competitive companies are not necessarily developing direct In-111 pentetreotide generics. They are commercializing alternative somatostatin-receptor PET agents.

Company	Relevant product or platform	Competitive effect
Curium	OctreoScan	Incumbent In-111 product
Advanced Accelerator Applications, a Novartis company	Netspot	Ga-68 PET competition
Telix Pharmaceuticals	Illuccix	Ga-68 PET competition
Curium and related commercial channels	Nuclear imaging portfolio	Distribution and portfolio competition
Radioisotope and radiopharmacy suppliers	In-111, Ga-68, Cu-64 supply	Determines availability and economics

The competitive market is increasingly defined by access to radionuclides and PET infrastructure rather than by patent litigation.

What manufacturing and intellectual-property barriers remain?

The remaining barriers are operational.

Manufacturing barriers

A prospective competitor must establish:

• GMP-compliant peptide production
• Validated radiolabeling procedures
• Sterility and endotoxin controls
• Radionuclide sourcing
• Stability data
• Radiation-safety procedures
• Reliable short-dated distribution
• FDA-compliant quality systems
• Hospital and nuclear-pharmacy implementation

In-111 supply is itself a strategic variable. The product requires a dependable isotope source and distribution network. A technically approvable product can still fail commercially if it cannot meet delivery windows or maintain consistent batch availability.

Intellectual-property barriers

The likely IP barriers are narrower:

• Process patents
• Kit formulation claims
• Manufacturing know-how
• Trade secrets
• Trademark rights
• Regulatory exclusivity for any newly developed alternative

These protections may deter small entrants but are unlikely to support premium pricing comparable with protected oncology therapeutics.

What generic launch scenarios exist for indium In-111 pentetreotide?

Three launch scenarios are plausible.

Scenario 1: Continued niche commercialization

The incumbent maintains supply to hospitals with limited PET access. Pricing remains stable or rises modestly to offset low volume and distribution costs. This is the most likely base case for a mature diagnostic product.

Scenario 2: Follow-on radiopharmaceutical entry

A competitor launches an equivalent or closely related kit through an ANDA or 505(b)(2) pathway. The entrant competes on price, availability, or distribution. The market could support more than one supplier, but total demand would remain constrained by PET substitution.

Scenario 3: Accelerated clinical displacement

PET adoption expands rapidly, and payer and guideline preferences favor Ga-68 or Cu-64 agents. In-111 volume falls to a residual market concentrated in countries and institutions without PET capacity.

A direct generic launch would create price pressure but would not reverse the underlying modality shift. The principal risk is loss of procedure volume, not only loss of product margin.

What patent litigation and settlement agreements affect OctreoScan?

No major current patent-litigation or settlement event is broadly associated with OctreoScan’s commercial position. The product’s central risk is technological substitution rather than an active patent dispute.

Any future dispute would more likely involve:

• A follow-on kit’s formulation or manufacturing process
• A trademark or trade dress issue
• Distribution rights
• Radiopharmaceutical supply contracts
• A new PET competitor’s patent estate
• Use of a particular chelator, peptide analog, or labeling method

Publicly disclosed product-specific licensing and settlement agreements are limited. The commercially relevant transaction history is more closely linked to portfolio ownership and nuclear-medicine asset transfers than to a high-value OctreoScan license.

How strong is the patent estate for indium In-111 pentetreotide?

The patent estate is weak as a source of durable commercial exclusivity and moderate as an operational protection system.

Risk category	Assessment
Composition-of-matter protection	Low
Orange Book patent leverage	Low
Formulation protection	Low to moderate
Manufacturing know-how	Moderate
Isotope supply access	Moderate to high
Regulatory execution barrier	Moderate
Brand and distribution recognition	Moderate
Vulnerability to PET substitution	High

The product can remain commercially viable without strong patents because radiopharmaceutical manufacturing and distribution are difficult. That advantage is defensive but not equivalent to exclusivity.

What is the geographic coverage and international outlook?

Demand is strongest in markets with established nuclear-medicine services and limited access to SSTR PET. The United States, Europe, Japan, and selected Middle Eastern and Asia-Pacific markets have the infrastructure to use In-111 products, but local demand varies substantially.

The international outlook depends on:

• National approval status
• Reimbursement
• PET scanner density
• Access to In-111 chloride
• Availability of Ga-68 and Cu-64
• Neuroendocrine tumor diagnosis rates
• Local nuclear-pharmacy capacity

In wealthier markets, SSTR PET is likely to continue taking share. In emerging markets, In-111 may have a longer commercial tail because it can operate within existing scintigraphy infrastructure.

Key Takeaways

• Indium In-111 pentetreotide is a mature diagnostic radiopharmaceutical, principally associated with OctreoScan.
• Its FDA approval dates to 1994, and meaningful product exclusivity has expired.
• The current commercial sponsor is Curium US LLC, according to recent FDA labeling.
• Standalone revenue is not publicly disclosed.
• Financial performance is likely declining but may remain positive in a niche market because of established manufacturing and distribution infrastructure.
• The main competitive threat is Ga-68 and Cu-64 somatostatin-receptor PET, not a conventional Paragraph IV challenge.
• Biosimilar risk does not apply.
• Formulation, manufacturing, isotope supply, and radiopharmacy logistics are more important than patent protection.
• A direct generic could pressure price, but PET substitution is the larger long-term risk.
• Geographic demand should persist where PET access, reimbursement, or isotope supply remains constrained.

FAQs

Is indium In-111 pentetreotide still FDA approved?

Yes. The product remains associated with FDA NDA 019793 and is indicated for localization of somatostatin-receptor-positive neuroendocrine tumors.

Is OctreoScan interchangeable with Ga-68 dotatate?

No. Both target somatostatin receptors, but they use different radionuclides and imaging modalities. Clinical substitution depends on FDA labeling, physician judgment, payer policy, and local PET availability.

Does OctreoScan have a viable generic opportunity?

A follow-on product is technically possible, but the addressable market is constrained by PET displacement and specialized manufacturing requirements. A 505(b)(2) pathway may be more practical than a conventional generic route in some circumstances.

Which radionuclide is better for neuroendocrine tumor imaging, In-111 or Ga-68?

Ga-68 PET generally provides higher-resolution and more efficient imaging. In-111 remains useful where PET capacity or PET tracer supply is limited.

Can OctreoScan be used to select patients for lutetium-177 dotatate therapy?

Modern treatment selection generally relies on somatostatin-receptor PET imaging when available. In-111 imaging may provide receptor-localization information in settings where PET is unavailable, subject to clinical judgment and applicable treatment protocols.

References

1. U.S. Food and Drug Administration. (2023). OctreoScan (indium In-111 pentetreotide) injection, kit for the preparation of. Curium US LLC.

2. U.S. Food and Drug Administration. (2016). Netspot (gallium Ga-68 dotatate injection) prescribing information. Advanced Accelerator Applications.

3. U.S. Food and Drug Administration. (2020). Detectnet (copper Cu-64 dotatate injection) prescribing information. Curium US LLC.

4. U.S. Food and Drug Administration. (2021). Illuccix (kit for the preparation of gallium Ga-68 gozetotide injection) prescribing information. Telix Pharmaceuticals.

5. Centers for Medicare & Medicaid Services. (2024). Healthcare Common Procedure Coding System, HCPCS code A9542: Indium In-111 pentetreotide, diagnostic, per study dose. U.S. Department of Health and Human Services.