INDIUM IN 111 OXYQUINOLINE Drug Patent Profile

When do Indium In 111 Oxyquinoline patents expire, and what generic alternatives are available?

Indium In 111 Oxyquinoline is a drug marketed by Bwxt Itg and Ge Healthcare and is included in two NDAs.

The generic ingredient in INDIUM IN 111 OXYQUINOLINE is indium in-111 oxyquinoline. There are twenty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the indium in-111 oxyquinoline profile page.

Summary for INDIUM IN 111 OXYQUINOLINE

US Patents:	0
Applicants:	2
NDAs:	2

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
Ge Healthcare	INDIUM IN 111 OXYQUINOLINE	indium in-111 oxyquinoline	INJECTABLE;INJECTION	019044-001	Dec 24, 1985	AP	RX	Yes	Yes

International Patents for INDIUM IN 111 OXYQUINOLINE

See the table below for patents covering INDIUM IN 111 OXYQUINOLINE around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0017355	INDIUM-111 OXINE COMPLEX COMPOSITION
Japan	S55129229	INDIUMM1111OXINE COMPLEX COMPOSITION
Germany	3062496
Japan	S5914452

INDIUM In-111 Oxyquinoline: Investment Scenario and Fundamentals Analysis

Last updated: March 2, 2026

What is INDIUM In-111 Oxyquinoline?

Indium-111 Oxyquinoline (In-111 Oxine) is a radiolabeled compound used in nuclear medicine. It functions as a radiotracer for cell labeling and tracking, primarily in clinical diagnostics and research applications. It is notable for its application in labeling leukocytes to identify infections, as well as transplant rejection monitoring.

Market Overview

The global nuclear medicine market is projected to grow from $7.2 billion in 2022 to over $13.5 billion by 2030, at a compound annual growth rate (CAGR) of 8.4% (Grand View Research, 2022)[1]. Radiotracers like In-111 Oxine contribute significantly to this growth, due to increasing demand for diagnostic imaging innovations.

Key Players and Patent Landscape

Major suppliers include Mallinckrodt Pharmaceuticals, Lantheus Medical Imaging, and advanced biotech companies developing radiochemistry products. The patent landscape indicates intense competition in production methods, with overlap in core patents until roughly 2030, suggesting potential for generic manufacturing post-expiry.

Fundamentals Analysis

Production Process

The synthesis involves complex radiolabeling of oxine (8-hydroxyquinoline) with indium-111. The process requires specialized facilities with isotope handling capabilities. Cost factors include isotope procurement, radiolabeling reagents, and compliance with regulatory standards.

Regulatory Milestones

In-111 Oxine is classified as a diagnostic radiopharmaceutical. Regulatory approval processes in the U.S. (FDA) and Europe (EMA) involve rigorous safety and efficacy data submission. SEC or equivalent agencies oversee manufacturing licenses and Good Manufacturing Practice (GMP) compliance.

Supply Chain Dynamics

Supply depends on the availability of indium-111, produced via molybdenum-99 decay in nuclear reactors. Moly-99 shortages have periodically constrained radiotracer availability, influencing market stability.

Intellectual Property

Most core patents for In-111 Oxine labeling procedures have expired or are nearing expiry, opening pathways for generic production. Ongoing innovation focuses on improving labeling stability, reducing production costs, and enhancing imaging quality.

Clinical Utility and Demand Drivers

In-111 Oxine's primary applications include infectious disease diagnosis, immune response evaluation, and transplant rejection monitoring. The instrument growth in personalized medicine and molecular imaging supports increased use.

Competitive Advantages and Risks

Advantages include high specificity for cell tracking, established clinical protocols, and robust safety profile. Risks encompass regulatory delays, radiation safety concerns, and dependency on isotope supply stability.

Investment Considerations

Factor	Observation
Market Growth	Steady growth driven by diagnostic imaging expansion
Patent Status	Expiry of major patents could enable generics
Supply Chain	Vulnerability due to molybdenum-99 shortages
Regulatory Path	Complex approval process can delay commercialization
R&D Trends	Focus on improved stability and imaging resolution

Opportunities and Challenges

Opportunities

• Development of next-generation radiotracers with enhanced targeting
• Strategic partnerships for supply chain resilience
• Entry into emerging markets with growing healthcare infrastructure

Challenges

• Fluctuations in isotope availability
• Regulatory hurdles for new formulations
• Competition from alternative imaging agents

Key Metrics for Investment Evaluation

• Market penetration rates
• Cost of goods sold (COGS) with updated manufacturing techniques
• Regulatory approval timelines
• Patent expiration dates
• Volume growth in clinical applications

Key Takeaways

• In-111 Oxine remains relevant in nuclear medicine, primarily for cell tracking applications.
• Market growth aligns with increasing demand for precise diagnostic tools.
• Patent expiries signal potential for generic expansion, but supply chain limitations pose risks.
• Regulatory complexity influences time-to-market and associated costs.
• Innovation focus centers on improving stability, imaging quality, and cost-effectiveness.

FAQs

Q1: What factors influence the pricing of In-111 Oxine radiotracers?
A1: Material costs, regulatory compliance, manufacturing complexity, and supply chain stability affect pricing.

Q2: How does patent expiry impact the market for In-111 Oxine?
A2: Patent expiry allows generic manufacturers to produce similar radiotracers, increasing competition and potentially lowering prices.

Q3: Are there emerging alternatives to In-111 Oxine?
A3: Yes, newer radiotracers like technetium-based agents are gaining popularity due to easier availability and fewer supply constraints.

Q4: How does the supply shortage of molybdenum-99 affect In-111 Oxine availability?
A4: It causes intermittent shortages, leading to delays in production and potential impacts on clinical availability.

Q5: What regulatory hurdles must be addressed for new formulations?
A5: Demonstrating safety, efficacy, and quality through clinical trials and manufacturing audits, often extending approval timelines.

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References

[1] Grand View Research. (2022). Nuclear Medicine Market Size, Share & Trends Analysis Report.