Last Updated: May 3, 2026

Indium in-111 chloride - Generic Drug Details


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

Indium in-111 chloride is the generic ingredient in two branded drugs marketed by Ge Healthcare and Curium, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for indium in-111 chloride.

Summary for indium in-111 chloride
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 3
DailyMed Link:indium in-111 chloride at DailyMed

US Patents and Regulatory Information for indium in-111 chloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Curium INDIUM IN 111 CHLORIDE indium in-111 chloride INJECTABLE;INJECTION 019841-001 Sep 27, 1994 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ge Healthcare INDICLOR indium in-111 chloride INJECTABLE;INJECTION 019862-001 Dec 29, 1992 DISCN Yes No ⤷  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

Market Dynamics and Financial Trajectory for Indium-111 Chloride

Last updated: February 15, 2026

Overview

Indium-111 chloride (In-111 chloride) is a radiopharmaceutical primarily used in diagnostic imaging, especially for detecting and localizing infections, tumors, and lymphatic systems. Its market depends on the nuclear medicine sector, regulatory approvals, technological advancements, and clinical demand.

Market Drivers

  1. Increasing Demand for Diagnostic Imaging
    The global nuclear medicine market, valued at $4.5 billion in 2021, is projected to reach $7 billion by 2030, with radiopharmaceuticals like In-111 chloride contributing significantly [1].

  2. Advancements in Oncology and Infectious Disease Detection
    Growing cancer prevalence and infectious diseases necessitate precise imaging agents. In-111 chloride's use in SPECT imaging aligns with these needs, driving demand.

  3. Regulatory Approvals and Research Initiatives
    No new approvals for In-111 chloride have been issued recently; however, ongoing clinical trials exploring its applications can influence market dynamics.

Market Challenges

  • Supply Constraints
    Indium-111 production relies on nuclear reactors, specifically from enriched uranium targets, leading to limited, centralized supply and potential shortages.

  • Regulatory Hurdles
    Strict regulatory pathways for radiopharmaceuticals increase development costs and timeframes.

  • Competition
    Replacement by PET tracers such as Gallium-68 and FLT reduces In-111 chloride’s market share.

Competitive Landscape

Company Product Portfolio Market Position Key Collaborations
GE Healthcare Indium-111-based imaging agents Leader Collaborations with nuclear medicine centers
Curium Pharmaceuticals Radiopharmaceutical manufacturing Growing presence Partnerships with research institutions
Advanced Medical Isotope Corporation Isotope supply Niche supplier Contracts with nuclear reactors

Financial Trajectory

  • Historical Revenue
    Exact revenue data for In-111 chloride are limited due to its niche status. Large radiopharmaceuticals divisions report combined revenues exceeding $300 million globally, with In-111 products contributing a minority share.

  • Market Growth Estimates
    Given the overall radiopharmaceutical market's CAGR of 5.3% (2022–2030), In-111 chloride market growth is estimated at approximately 2–3% annually, constrained by supply and competition.

  • Pricing Dynamics
    In-111 chloride unit prices hover between $250–$400 per dose, influenced by isotope purity, synthesis complexity, and regulatory compliance.

  • Investment Outlook
    Limited R&D pipelines and reliance on aging reactor-generated isotopes might impede substantial revenue growth. Investment opportunities lie in improving isotope production and expanding clinical indications.

Future Outlook

Short-term growth aligns with increased imaging procedures and clinical research, but medium-term prospects depend on supply chain stabilization and alternative imaging modalities. The shift toward PET-based techniques reduces long-term demand for In-111 chloride except where specific clinical advantages exist.

Key Factors Influencing Market Trajectory

  • Supply stability of Indium-111 isotope, hinged on reactor capacity.
  • Regulatory approval processes for new indications.
  • Competitive effect of emerging PET tracers.
  • Adoption in emerging markets with expanding nuclear medicine infrastructure.

Summary

Indium-111 chloride's market remains niche but steady, with slow growth driven by clinical applications and incremental technological improvements. Supply constraints and competition from PET tracers temper growth prospects. Investments focusing on isotope supply chain resilience and clinical application expansion could influence future revenue potential.


Key Takeaways

  • The global radiopharmaceutical market is expanding, but In-111 chloride faces challenges from supply limitations and competing modalities.
  • Revenue estimates for In-111 chloride are modest and grow slowly at 2–3% annually.
  • Market growth depends on isotope production stability, regulatory approvals, and clinical demand.
  • Price per dose remains within $250–$400, influenced by isotope quality and synthesis complexity.
  • Companies are exploring supply chain improvements and new clinical applications to sustain or grow market share.

FAQs

1. What are the primary clinical uses of In-111 chloride?
Diagnosis and localization of infections, tumors, and lymphatic imaging.

2. How is Indium-111 produced?
Via neutron irradiation of enriched cadmium or indium targets in nuclear reactors.

3. What are the main competitors to In-111 chloride?
PET tracers like Gallium-68 and fluorine-based agents.

4. What regulatory barriers exist for In-111 chloride?
Approval processes involve strict safety and efficacy assessments by agencies such as the FDA and EMA.

5. Can supply shortages impact market viability?
Yes, reliance on reactor-produced isotopes can cause supply disruptions, affecting availability and pricing.


Sources

[1] Grand View Research, "Radiopharmaceuticals Market Size & Trends," 2022.

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