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Last Updated: December 22, 2024

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
Patent Applications: 31
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
Bwxt Itg INDIUM IN 111 OXYQUINOLINE indium in-111 oxyquinoline INJECTABLE;INJECTION 202586-001 Jul 25, 2018 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ge Healthcare INDIUM IN 111 OXYQUINOLINE indium in-111 oxyquinoline INJECTABLE;INJECTION 019044-001 Dec 24, 1985 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

INDIUM IN-111 OXYQUINOLINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Indium In-111 Oxyquinoline

Introduction

Indium In-111 oxyquinoline is a diagnostic radiopharmaceutical used for radiolabeling autologous leukocytes, primarily to detect inflammatory processes such as abscesses or other infections. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Overview

The market for diagnostic radiopharmaceuticals, including Indium In-111 oxyquinoline, is influenced by several key factors:

Demand and Indications

Indium In-111 oxyquinoline is indicated for radiolabeling autologous leukocytes to help in the detection of inflammatory processes. The demand for this drug is driven by the need for accurate diagnostic tools in nuclear medicine, particularly in cases where traditional imaging methods are insufficient[3][4].

Competition

The radiopharmaceutical market is competitive, with several players involved in the production and distribution of various diagnostic agents. However, the approval of BWXT's generic version of Indium In-111 oxyquinoline in 2019 marked a significant entry into the market, providing an alternative to existing products[1].

Regulatory Environment

Regulatory approvals play a crucial role in the market dynamics of radiopharmaceuticals. The FDA approval of BWXT's Indium In-111 oxyquinoline solution was a key milestone, enabling the company to enter the U.S. market[1].

Financial Trajectory

Revenue Potential

The revenue potential for Indium In-111 oxyquinoline is tied to its adoption in clinical settings. With its FDA approval, BWXT is well-positioned to capture a share of the market. The company's commitment to broadening its product portfolio suggests a strategic approach to increasing revenue through diversified offerings[1].

Cost Factors

The cost of radiopharmaceuticals, including Indium In-111 oxyquinoline, can be significant. The transition from highly-enriched uranium to other sources for medical isotopes has led to increased costs, which are often passed on to healthcare organizations. This trend could impact the financial trajectory of the drug, as healthcare providers may face challenges in managing these costs[5].

Pricing and Reimbursement

Pricing strategies and reimbursement models are critical in determining the financial success of radiopharmaceuticals. The cost of preparing and acquiring these drugs can be high, and reimbursement models may need to be adjusted to ensure that healthcare organizations can afford these diagnostic tools without compromising patient care[5].

Market Trends

Technological Advancements

Advancements in nuclear medicine and imaging technologies continue to drive the demand for diagnostic radiopharmaceuticals. The ability of Indium In-111 oxyquinoline to penetrate cell membranes and emit gamma rays detectable by gamma ray cameras makes it a valuable tool in modern diagnostic practices[3][4].

Supply Chain Dynamics

The supply chain for radiopharmaceuticals is complex and can be volatile. Factors such as the availability of raw materials (e.g., medical isotopes) and manufacturing capacities can impact the supply and pricing of these drugs. Ensuring a stable and sustainable supply chain is essential for maintaining market stability[5].

Industry Challenges

Regulatory Compliance

Compliance with regulatory requirements is a significant challenge in the radiopharmaceutical market. Companies must navigate complex regulatory frameworks to ensure their products meet safety and efficacy standards. BWXT's successful navigation of the FDA approval process for Indium In-111 oxyquinoline is a testament to the importance of regulatory compliance[1].

Cost Management

Managing the high costs associated with the production and procurement of radiopharmaceuticals is a major challenge. Healthcare organizations face increasing expenses due to the conversion to non-HEU sources and the consolidation of manufacturers, which can lead to higher prices and reduced competition[5].

Future Outlook

Market Growth

The market for diagnostic radiopharmaceuticals is expected to grow, driven by the increasing demand for advanced diagnostic tools in nuclear medicine. Indium In-111 oxyquinoline, with its specific indications and FDA approval, is well-positioned to benefit from this growth[1].

Innovation and Diversification

BWXT's commitment to broadening its product portfolio suggests a future focus on innovation and diversification. This strategy could help the company maintain a competitive edge and expand its revenue streams in the radiopharmaceutical market[1].

Key Takeaways

  • Regulatory Approvals: FDA approval is crucial for market entry and success.
  • Demand and Indications: The drug's specific use in detecting inflammatory processes drives demand.
  • Cost Factors: High production and procurement costs impact the financial trajectory.
  • Pricing and Reimbursement: Effective reimbursement models are necessary to manage costs.
  • Supply Chain Dynamics: Stability in the supply chain is essential for market stability.
  • Future Outlook: Market growth and innovation are key to future success.

FAQs

What is Indium In-111 oxyquinoline used for?

Indium In-111 oxyquinoline is used for radiolabeling autologous leukocytes to detect inflammatory processes such as abscesses or other infections[3][4].

Who approved Indium In-111 oxyquinoline for use in the U.S.?

The U.S. Food and Drug Administration (FDA) approved Indium In-111 oxyquinoline for use in the U.S.[1].

What are the key challenges in the market for radiopharmaceuticals?

Key challenges include regulatory compliance, cost management, and ensuring a stable supply chain[1][5].

How does the cost of Indium In-111 oxyquinoline impact healthcare organizations?

The high cost of radiopharmaceuticals, including Indium In-111 oxyquinoline, can significantly increase expenses for healthcare organizations, potentially affecting their ability to provide efficacious diagnostic tests[5].

What is the future outlook for the market of Indium In-111 oxyquinoline?

The market is expected to grow, driven by increasing demand for advanced diagnostic tools in nuclear medicine, with a focus on innovation and diversification to maintain competitiveness[1].

Sources

  1. BWXT Announces Availability of FDA-Approved Indium In-111 Oxyquinoline Solution - BWXT Medical.
  2. Following are the abstracts from the Third Annual ... - Sage Journals.
  3. INDIUM In 111 OXYQUINOLINE SOLUTION - FDA.
  4. Indium In-111 oxyquinoline: Uses, Interactions, Mechanism of Action - DrugBank.
  5. Can the SPECT nuclear imaging modality be sustained? - RPOF Indy.

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