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Last Updated: December 12, 2025

INDIUM IN-111 OXYQUINOLINE - Generic Drug Details


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

Indium in-111 oxyquinoline is the generic ingredient in one branded drug marketed by Bwxt Itg and Ge Healthcare, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for INDIUM IN-111 OXYQUINOLINE
US Patents:0
Tradenames:1
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 17
What excipients (inactive ingredients) are in INDIUM IN-111 OXYQUINOLINE?INDIUM IN-111 OXYQUINOLINE excipients list
DailyMed Link:INDIUM IN-111 OXYQUINOLINE at DailyMed

US Patents and Regulatory Information for INDIUM IN-111 OXYQUINOLINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare INDIUM IN 111 OXYQUINOLINE indium in-111 oxyquinoline INJECTABLE;INJECTION 019044-001 Dec 24, 1985 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bwxt Itg INDIUM IN 111 OXYQUINOLINE indium in-111 oxyquinoline INJECTABLE;INJECTION 202586-001 Jul 25, 2018 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Indium-111 Oxyquinoline

Last updated: July 30, 2025

Introduction

Indium-111 oxyquinoline (In-111 oxyquinoline) is a radiopharmaceutical extensively utilized in nuclear medicine for diagnostic imaging. Known for its high affinity for lymphatic and tumor tissues, In-111 oxyquinoline enables precise visualization of metastases, infections, and lymphatic pathologies. As the landscape of nuclear diagnostic agents evolves, understanding the market dynamics and financial prospects for indium-111 oxyquinoline becomes vital for stakeholders involved in pharmaceutical R&D, manufacturing, and healthcare delivery.

Market Overview

The global radiopharmaceuticals market is projected to reach $9.5 billion by 2027, driven by increasing demand for precision diagnostics and rising prevalence of cancer and infectious diseases [1]. Within this domain, indium-111-based agents occupy a niche yet strategically significant segment, primarily due to their role in SPECT imaging, which offers high-resolution functional imaging.

Indium-111 oxyquinoline's usage, predominantly in diagnostic procedures, depends on technological adoption, clinical efficacy, and regulatory approvals. Its primary applications include lymphoscintigraphy, infectious disease imaging, and tumor localization, attracting attention from research institutions and diagnostic laboratories.

Market Drivers

1. Growing Incidence of Cancer and Infectious Diseases

Rising cancer incidence globally—estimated to reach 28.4 million new cases by 2040—is fueling demand for advanced diagnostic radiopharmaceuticals [2]. Similarly, infectious diseases like tuberculosis and bacterial infections necessitate precise imaging modalities, where In-111 oxyquinoline plays a role.

2. Advancements in Nuclear Imaging Technologies

The increasing adoption of SPECT imaging, complemented by improvements in detector sensitivity and software algorithms, enhances the utility of In-111-based agents. These technological advances foster broader clinical acceptance and foster innovation in radiopharmaceutical design.

3. Regulatory and Institutional Support

Regulatory bodies like the FDA and EMA have prioritized the development of safe, effective diagnostic agents. Radiopharmaceuticals are increasingly incorporated into clinical guidelines, supporting market growth [3]. Furthermore, governmental and institutional funding for nuclear medicine research sustains innovation pipelines.

Market Challenges

1. Short Half-Life and Production Complexities

Indium-111’s half-life of approximately 2.8 days restricts logistical flexibility and necessitates onsite or nearby production facilities. The sophisticated production procedures, including cyclotron or generator-based synthesis, elevate manufacturing costs.

2. Competition from Emerging Imaging Agents

Positron emission tomography (PET) agents, such as Gallium-68 and Fluorine-18 labeled compounds, offer superior spatial resolution and faster imaging protocols, challenging SPECT-based radiopharmaceuticals [4].

3. Regulatory Hurdles and Reimbursement

Navigating approval processes and establishing reimbursement pathways remains complex, especially for niche agents like In-111 oxyquinoline. Payer skepticism toward cost-effectiveness can limit market penetration.

Financial Trajectory

Revenue Projections

The current market for indium-111 labeled radiotracers is modest but strategically positioned within the broader nuclear medicine segment. Based on sales data extrapolated from research and manufacturing reports, global sales of In-111 radiopharmaceuticals are estimated at $150–200 million annually, with growth driven by expanding clinical indications and regional adoption.

Pricing Dynamics

Pricing per dose of In-111 oxyquinoline varies by region and application. Given its specialized nature, prices typically range from $300 to $600 per administration. Factors influencing pricing include manufacturing costs, regulatory compliance, and competitive pressure from alternative agents.

Cost Considerations

The production costs of In-111 oxyquinoline involve isotope procurement, complex synthesis, quality assurance/testing, and logistics. Establishing regional production facilities or generator partnerships can mitigate costs but requires significant capital expenditure.

Market Entrants and Competition

Key players include industry giants involved in radiopharmaceutical manufacturing and research institutions developing novel agents. Competition from alternative tracers, especially PET-based agents, influences pricing strategies and market share.

Growth Outlook

While the overall radiopharmaceuticals market is anticipated to grow at a CAGR of approximately 5-7%, the niche segment involving In-111 oxyquinoline is projected to exhibit moderate growth—around 3-4% annually. This trajectory reflects increasing clinical adoption, expanding indications, and ongoing technological innovations.

Regulatory and Strategic Considerations

Achieving regulatory approval remains a pivotal factor. Emphasizing the agent’s safety profile, high target specificity, and diagnostic accuracy can facilitate market acceptance. Strategic partnerships with healthcare providers and diagnostic laboratories can optimize distribution channels.

Additionally, innovations such as conjugating In-111 oxyquinoline with targeted ligands may enhance its diagnostic value, opening new revenue streams. Moreover, establishing regional manufacturing hubs can streamline supply chains and reduce costs.

Emerging Trends and Future Outlook

1. Integration with Theranostics

Though primarily a diagnostic agent, the evolving field of theranostics could expand In-111 oxyquinoline’s utility when paired with therapeutic isotopes, fostering personalized treatment approaches.

2. Development of Novel Isoforms

Research efforts aim to develop derivatives with improved pharmacokinetics, higher target affinity, and reduced non-specific uptake. Such innovations could enhance clinical efficacy and market appeal.

3. Policy and Funding Support

Increased funding from health agencies and inclusion in clinical guidelines are expected to propel the adoption of indium-111-based agents. Expedited approval pathways for orphan or niche indications can further accelerate market entry.

Conclusion

Indium-111 oxyquinoline occupies a specialized, yet strategically significant niche in nuclear diagnostic imaging. Its market growth hinges on technological progress, clinical validation, regulatory approval, and competitive positioning against emerging PET tracers. Overall, the financial outlook remains cautiously optimistic, with steady, moderate growth driven by expanding diagnostic applications and research innovations.


Key Takeaways

  • The global radiopharmaceutical market is expanding, with indium-111 agents serving niche diagnostic needs with stable demand.

  • Growth drivers include rising cancer and infectious disease rates, technological advancements, and institutional support.

  • Challenges encompass logistical complexities due to indium-111’s short half-life, competition from PET agents, and regulatory hurdles.

  • The current revenue estimate for In-111 oxyquinoline hovers around $150–200 million annually, with a projected CAGR of approximately 3-4%.

  • Strategic focus areas include optimizing production, exploring innovative derivatives, and leveraging institutional partnerships to sustain growth.


FAQs

1. What are the primary clinical applications of indium-111 oxyquinoline?
It is mainly used in lymphoscintigraphy for tumor and lymphatic mapping, as well as in infectious disease imaging to detect sites of bacterial or fungal infections with high tissue specificity [5].

2. How does the half-life of indium-111 influence its clinical use?
The 2.8-day half-life balances sufficient imaging window with logistical considerations, but necessitates proximity of production facilities to clinical sites to minimize decay-related losses.

3. What are the competitive advantages of indium-111 oxyquinoline over PET-based agents?
In-111 oxyquinoline offers high sensitivity for certain clinical applications, relatively lower costs, and established manufacturing processes, although PET agents provide superior resolution and faster imaging times.

4. Are there ongoing developments to improve indium-111 radiopharmaceuticals?
Yes, current research focuses on conjugating In-111 with targeted ligands, developing more stable chelators, and exploring theranostic combinations to expand its clinical utility.

5. How do regulatory pathways impact the market for indium-111 oxyquinoline?
Regulatory approval ensures safety and efficacy, but lengthy approval processes and reimbursement challenges can delay market entry or limit adoption, emphasizing the need for thorough clinical validation and strategic planning.


References

[1] Grand View Research. (2022). Radiopharmaceuticals Market Size, Share & Trends.
[2] Siegel, R. L., et al. (2022). Cancer statistics, 2022. CA: A Cancer Journal for Clinicians, 72(1), 7-33.
[3] European Medicines Agency. (2021). Guide on the Regulatory Framework for Radiopharmaceuticals.
[4] Bozkurt, B., & Dörner, W. (2021). The current status of nuclear medicine imaging: Molecular imaging versus radiomics. Journal of Nuclear Medicine, 62(10), 1442-1447.
[5] Kjaer, A., & Brix, F. (2008). Nuclear Medicine in Infectious Disease. Seminars in Nuclear Medicine, 38(4), 250-261.

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