Generic INDIUM IN-111 PENTETATE DISODIUM INN entry, drug patent expiry and freedom to operate

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	MPI INDIUM DTPA IN 111	indium in-111 pentetate disodium	INJECTABLE;INTRATHECAL	017707-001	Feb 18, 1982		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: February 19, 2026

What is Indium In-111 Pentetate Disodium's Current Market Position?

Indium In-111 pentetate disodium is a radiopharmaceutical used in diagnostic imaging, primarily for the detection of tumors and infections. Its market position is defined by its established role in specific imaging applications and its competition with alternative diagnostic agents and imaging modalities.

The compound is a chelating agent that binds to the radioisotope Indium-111 (¹¹¹In). This radiolabeling allows for the visualization of biological processes and anatomical structures through gamma camera imaging. Its primary applications include:

Oncology: Imaging of various cancers, including lymphoma, neuroblastoma, and melanoma, to assess tumor extent, response to therapy, and recurrence.
Infection Imaging: Detecting foci of infection, such as osteomyelitis and abscesses, particularly in difficult-to-diagnose cases.
Cardiac Imaging: Assessment of myocardial viability and inflammation.

The global radiopharmaceuticals market, which includes agents like In-111 pentetate disodium, is driven by factors such as the increasing prevalence of chronic diseases, advancements in nuclear medicine technology, and the growing demand for early and accurate diagnosis. However, the market is also influenced by the cost of radiopharmaceuticals, regulatory hurdles, and the development of novel imaging agents and techniques.

What is the Competitive Landscape for Indium In-111 Pentetate Disodium?

The competitive landscape for In-111 pentetate disodium is characterized by the presence of both direct and indirect competitors.

Direct Competitors:

These are other radiopharmaceuticals that can be used for similar diagnostic purposes.

Technetium-99m (⁹⁹mTc) based agents: ⁹⁹mTc is the most widely used radioisotope in nuclear medicine due to its favorable imaging properties and relatively low cost. Various ⁹⁹mTc-labeled compounds are used for bone imaging, infection imaging (e.g., ⁹⁹mTc-labeled white blood cells), and cardiac imaging. While ⁹⁹mTc offers advantages in terms of availability and cost, ¹¹¹In generally provides longer imaging windows and better lesion-to-background ratios in specific applications, particularly for tumor imaging.
Other Indium-111 labeled agents: While In-111 pentetate disodium is a specific formulation, other chelating agents can also be labeled with ¹¹¹In for targeted imaging.
Fluorine-18 (¹⁸F) based PET tracers: Positron emission tomography (PET) tracers, particularly ¹⁸F-FDG (fluorodeoxyglucose), have become dominant in oncologic imaging. PET offers higher sensitivity and resolution compared to SPECT (single-photon emission computed tomography), which is used with ¹¹¹In. ¹⁸F-FDG is widely used for staging and monitoring a broad range of cancers.

Indirect Competitors:

These are alternative diagnostic modalities that do not involve radiopharmaceuticals.

Magnetic Resonance Imaging (MRI): MRI provides excellent soft tissue contrast and is widely used for oncologic imaging, neurological disorders, and musculoskeletal conditions. It does not involve ionizing radiation.
Computed Tomography (CT): CT offers high spatial resolution and is effective for visualizing bone, lung, and abdominal structures. It also uses ionizing radiation.
Ultrasound: Ultrasound is a cost-effective and widely available imaging technique, particularly useful for evaluating soft tissues, blood flow, and guiding interventional procedures.

The market share of In-111 pentetate disodium is influenced by the specific clinical indication. For certain types of lymphoma and for specific infection imaging scenarios where prolonged imaging is beneficial or where PET is not readily available or indicated, In-111 pentetate disodium maintains its utility. However, the broad adoption of ¹⁸F-FDG PET/CT for oncologic staging and the increasing availability of advanced MRI techniques pose significant competitive pressures.

What are the Key Patents and Intellectual Property Protecting In-111 Pentetate Disodium?

The intellectual property landscape surrounding Indium In-111 pentetate disodium is complex, encompassing patents related to the synthesis, formulation, and specific uses of the compound.

General Patenting Strategy:

Pharmaceutical companies typically seek patent protection for novel radiopharmaceutical compounds, their manufacturing processes, specific formulations that improve stability or delivery, and new therapeutic or diagnostic uses. For established compounds like In-111 pentetate disodium, the core compound itself may be off-patent. However, patents can exist for:

Improved Synthesis Methods: Patents may cover novel or more efficient chemical pathways for synthesizing the chelating agent or for labeling it with ¹¹¹In. These patents aim to protect the manufacturing process, potentially offering cost advantages or higher purity.
Novel Formulations: Patents can protect specific formulations of In-111 pentetate disodium, such as those designed for enhanced stability, reduced toxicity, or improved pharmacokinetic properties. This could include different excipients, pH adjustments, or specialized delivery systems.
New Diagnostic or Therapeutic Uses: Patents are often sought for new applications of existing drugs. For In-111 pentetate disodium, this could involve its use in diagnosing specific diseases or stages of disease that were not previously covered by existing patents. This is a common strategy to extend the commercial life of a drug.
Combination Therapies: Patents may cover the use of In-111 pentetate disodium in conjunction with other diagnostic agents or therapeutic treatments.

Specific Patent Considerations for In-111 Pentetate Disodium:

The original development and patenting of In-111 pentetate disodium would have occurred decades ago. The core chemical entity and its initial intended uses are likely in the public domain, meaning their fundamental patents have expired. However, manufacturers may hold patents on:

Specific Manufacturing Processes: Companies that have refined the production of high-purity In-111 pentetate disodium may hold patents on these proprietary manufacturing techniques. For example, patents might exist for methods to achieve specific isotopic purity or to ensure sterility and stability for extended shelf life.
Formulation Enhancements: Modern formulations might incorporate advancements in stabilization or handling that are protected by patent.
New Indications: Research into new diagnostic applications or specific patient populations could lead to new use patents.

Challenges in Identifying Specific Patents:

Identifying all relevant patents requires thorough searches of patent databases (e.g., USPTO, EPO, WIPO) using keywords, inventor names, and assignee names. The complexity arises because:

Assignee Changes: Companies may have been acquired or merged, leading to changes in patent ownership.
Global Patenting: Patents are geographically specific; a patent in one country does not guarantee protection in another.
"Evergreening" Strategies: Companies may file multiple patents around a single drug, covering different aspects of its lifecycle, to prolong market exclusivity.

As of current knowledge, the primary patent protection for the original In-111 pentetate disodium compound has likely expired. However, companies involved in its current manufacturing and distribution may hold patents on specific manufacturing processes, formulations, or novel applications that are crucial for their market exclusivity. Companies like Bayer AG and others involved in radiopharmaceutical production are likely holders of such specific patents. A detailed patent landscape analysis would be required to identify specific active patents and their expiration dates.

What is the Financial Trajectory and Revenue Potential of In-111 Pentetate Disodium?

The financial trajectory of Indium In-111 pentetate disodium is influenced by its established, albeit niche, market position, manufacturing costs, and the pricing strategies employed by its suppliers. Revenue potential is constrained by competition from newer technologies and the limited scope of its primary indications.

Market Size and Growth:

The market for In-111 pentetate disodium is a segment within the larger radiopharmaceuticals market. This segment is not characterized by high growth rates. Instead, its revenue is driven by:

Stable Demand in Specific Applications: For validated indications like certain types of lymphoma imaging and difficult-to-diagnose infections, demand remains consistent.
Healthcare Infrastructure: The availability of SPECT/CT imaging equipment, which is required for its use, directly impacts demand.
Reimbursement Policies: Favorable reimbursement from healthcare payers for diagnostic procedures utilizing In-111 pentetate disodium is critical for revenue generation.

While precise revenue figures for In-111 pentetate disodium alone are not publicly disclosed by manufacturers, industry reports on the SPECT radiopharmaceuticals market can offer insights. The global SPECT radiopharmaceuticals market was valued at approximately USD 2.0 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 5-6% through 2030 [1]. In-111 pentetate disodium represents a small fraction of this market.

Pricing and Profitability:

The pricing of radiopharmaceuticals is complex. Key factors include:

Manufacturing Costs: The production of radiopharmaceuticals involves specialized facilities, trained personnel, and stringent quality control. The cost of the radioisotope ¹¹¹In itself, and its cyclotron production, contributes significantly.
Shelf Life: Radiopharmaceuticals have short half-lives (¹¹¹In has a half-life of approximately 2.8 days), requiring just-in-time manufacturing and distribution, which increases logistical costs.
Specialty Pricing: As a specialized diagnostic agent with limited alternatives for certain applications, it can command premium pricing.
Competition: The presence of alternative imaging modalities and radiopharmaceuticals exerts downward pressure on pricing.

Profitability for manufacturers depends on achieving economies of scale in production and efficient supply chain management. Companies that hold patents on improved manufacturing processes or formulations may be able to achieve higher profit margins.

Future Revenue Outlook:

The revenue trajectory for In-111 pentetate disodium is likely to be stable to moderately declining in the long term.

Continued Utility in Niche Applications: Its established role in specific lymphoma and infection imaging will ensure a baseline demand.
Competition from PET/CT: The increasing adoption of ¹⁸F-FDG PET/CT for oncologic imaging will continue to erode market share for SPECT agents like In-111 pentetate disodium in oncology.
Development of Novel SPECT Agents: Ongoing research may yield new SPECT agents with superior diagnostic capabilities, further challenging existing agents.
Technological Advancements: Improvements in MRI and other non-nuclear imaging techniques may also reduce reliance on SPECT imaging.

Therefore, while In-111 pentetate disodium will likely remain a relevant diagnostic tool for the foreseeable future, its revenue contribution to the broader pharmaceutical market is expected to be modest and potentially decline as newer technologies become more prevalent and cost-effective. Investment decisions should consider this mature and competitive market dynamic.

What are the Regulatory and Manufacturing Considerations for In-111 Pentetate Disodium?

The manufacturing and regulatory landscape for Indium In-111 pentetate disodium is highly specialized, dictated by the nature of radioactive materials and the stringent requirements for pharmaceutical products.

Manufacturing Process:

The production of In-111 pentetate disodium involves several critical steps:

Radioisotope Production: Indium-111 (¹¹¹In) is typically produced in cyclotrons via nuclear reactions, such as proton bombardment of Cadmium-112 (¹¹²Cd) or electron capture decay of ¹⁰⁹Cd. This process requires specialized high-energy particle accelerators and licensed facilities.
Chelation and Labeling: The ¹¹¹In radionuclide is then chelated with pentetate (DTPA - diethylenetriaminepentaacetic acid) and formulated as the disodium salt. This involves precise chemical reactions under controlled conditions to ensure the radioisotope is tightly bound to the chelating agent, forming the stable radiopharmaceutical.
Formulation and Sterilization: The final product is formulated in a sterile saline solution, often in vials designed for single or multi-dose use. Sterilization methods suitable for radiopharmaceuticals, such as sterile filtration, are employed.
Quality Control: Rigorous quality control testing is performed at multiple stages to ensure product identity, purity, potency, sterility, and the absence of pyrogens. Radiochemical purity (the percentage of radioactivity bound to the desired molecule) is a critical parameter.
Packaging and Distribution: The product is packaged in lead-shielded containers to protect personnel from radiation exposure. Distribution requires specialized logistics to ensure rapid delivery to nuclear medicine departments while maintaining product integrity and regulatory compliance.

Regulatory Oversight:

In-111 pentetate disodium, like all radiopharmaceuticals, is subject to strict regulatory oversight by national health authorities.

United States: The U.S. Food and Drug Administration (FDA) regulates radiopharmaceuticals as drugs. Manufacturers must obtain an Investigational New Drug (IND) application to conduct clinical trials and subsequently a New Drug Application (NDA) for marketing approval. Manufacturing facilities must comply with Current Good Manufacturing Practices (cGMP) as outlined in 21 CFR Part 210 and 211, with specific annexes for radiopharmaceuticals. The Nuclear Regulatory Commission (NRC) also has oversight regarding the handling, possession, and use of radioactive materials.
European Union: The European Medicines Agency (EMA) oversees the approval of medicinal products. Radiopharmaceuticals fall under the purview of the EMA and national competent authorities. Manufacturing must adhere to EU GMP guidelines, which include specific annexes for radiopharmaceuticals.
Other Jurisdictions: Similar regulatory frameworks exist in other countries, often modeled after FDA or EMA guidelines.

Key Regulatory Considerations:

Licensing: Manufacturers and users of radioactive materials require specific licenses from regulatory bodies.
Good Manufacturing Practices (GMP): Adherence to GMP is non-negotiable, ensuring product quality, safety, and efficacy. This includes stringent documentation, validation of processes, and personnel training.
Radioactive Material Handling and Safety: Regulations govern the safe handling, storage, transportation, and disposal of radioactive substances to protect patients, healthcare professionals, and the environment.
Pharmacovigilance: Post-market surveillance for adverse events and quality defects is mandatory.
Labeling Requirements: Product labeling must comply with regulatory standards, including information on dosage, administration, contraindications, warnings, and storage.

Challenges in Manufacturing and Regulation:

Limited Number of Manufacturers: Due to the highly specialized nature of radiopharmaceutical production, the number of global manufacturers is limited, which can impact supply chain resilience.
High Capital Investment: Setting up and maintaining a radiopharmaceutical manufacturing facility requires substantial capital investment in cyclotrons, hot labs, and specialized equipment.
Short Half-Life: The short half-life of ¹¹¹In necessitates precise planning and rapid turnaround times, increasing operational complexity and cost.
Evolving Regulations: Regulatory requirements are dynamic and can necessitate ongoing investments in compliance and quality systems.

The regulatory pathway for In-111 pentetate disodium involves continuous compliance with established pharmaceutical and nuclear regulations, making it a high-barrier-to-entry product category.

Key Takeaways

Indium In-111 pentetate disodium is a diagnostic radiopharmaceutical with established applications in oncology and infection imaging.
Its market position is characterized by competition from Technetium-99m based agents, other Indium-111 radiopharmaceuticals, and increasingly, Fluorine-18 PET tracers. Indirect competition also comes from advanced non-nuclear imaging modalities like MRI and CT.
While core patents for the compound have likely expired, manufacturers may hold patents on proprietary synthesis methods, improved formulations, or novel diagnostic uses.
The financial trajectory of In-111 pentetate disodium is stable to moderately declining, driven by consistent demand in niche applications but constrained by the rise of PET/CT and other advanced imaging technologies.
Manufacturing requires specialized cyclotron facilities, adherence to strict cGMP, and compliance with national and international radiopharmaceutical regulations, representing significant barriers to entry.

Frequently Asked Questions

What is the primary advantage of using Indium In-111 pentetate disodium over other SPECT agents? In-111 pentetate disodium offers a longer imaging window compared to many Technetium-99m based agents due to its longer half-life (approximately 2.8 days vs. 6 hours for ⁹⁹mTc). This allows for better lesion visualization and assessment in specific scenarios, particularly for imaging processes that evolve over time or for delayed imaging to improve lesion-to-background ratios.
Which specific types of cancers are best suited for diagnosis with Indium In-111 pentetate disodium? It is most commonly used for imaging certain types of lymphomas (e.g., non-Hodgkin lymphoma) and for neuroblastoma. Its utility in other solid tumors is less prominent compared to ¹⁸F-FDG PET imaging.
What are the main challenges in distributing Indium In-111 pentetate disodium? The primary challenge is its relatively short half-life, which necessitates rapid production, precise logistical planning, and immediate delivery to healthcare facilities. This limited shelf life also means that waste management of unused product requires careful handling due to radioactivity.
How does the cost of Indium In-111 pentetate disodium compare to ¹⁸F-FDG PET tracers? Generally, ¹⁸F-FDG is more widely produced and utilized, often leading to lower per-dose costs for the tracer itself, especially in high-volume diagnostic centers. The overall cost comparison also depends on the combined cost of the radioisotope production, manufacturing, distribution, and the imaging equipment (SPECT/CT vs. PET/CT). However, ¹⁸F-FDG is often considered more cost-effective for broad oncologic screening and staging due to its higher sensitivity and wider applicability.
Are there any significant side effects associated with Indium In-111 pentetate disodium administration? As a diagnostic radiopharmaceutical, In-111 pentetate disodium is generally well-tolerated. The primary risks are associated with radiation exposure, which is minimized by using the lowest effective dose for diagnostic purposes. Allergic reactions are rare but possible. Clinical efficacy and safety are evaluated during the drug approval process, and specific contraindications and warnings are detailed in the product labeling.

Cited Sources

[1] Grand View Research. (2023). SPECT Radiopharmaceuticals Market Size, Share & Trends Analysis Report By Type (Technetium-99m, Indium-111, Others), By Application (Oncology, Cardiology, Neurology, Others), By Region, And Segment Forecasts, 2023 - 2030. Grand View Research. Retrieved from https://www.grandviewresearch.com/industry-analysis/spect-radiopharmaceuticals-market

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in indium in-111 pentetate disodium?	indium in-111 pentetate disodium excipients list
DailyMed Link:	indium in-111 pentetate disodium at DailyMed

Indium in-111 pentetate disodium - Generic Drug Details

What are the generic drug sources for indium in-111 pentetate disodium and what is the scope of freedom to operate?

Summary for indium in-111 pentetate disodium

US Patents and Regulatory Information for indium in-111 pentetate disodium

In-111 Pentetate Disodium: Market Dynamics and Financial Trajectory