INDIUM IN 111 OXYQUINOLINE Drug Patent Profile

Which patents cover Indium In 111 Oxyquinoline, and when can generic versions of Indium In 111 Oxyquinoline launch?

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
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	8
Patent Applications:	58
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
Ge Healthcare	INDIUM IN 111 OXYQUINOLINE	indium in-111 oxyquinoline	INJECTABLE;INJECTION	019044-001	Dec 24, 1985	AP	RX	Yes	Yes

Expired US Patents for INDIUM IN 111 OXYQUINOLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	INDIUM IN 111 OXYQUINOLINE	indium in-111 oxyquinoline	INJECTABLE;INJECTION	019044-001	Dec 24, 1985	4,335,095

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
Japan	S5914452
European Patent Office	0017355	INDIUM-111 OXINE COMPLEX COMPOSITION
Germany	3062496
Japan	S55129229	INDIUMM1111OXINE COMPLEX COMPOSITION

Market Dynamics and Financial Trajectory for INDIUM IN 111 OXYQUINOLINE

Last updated: August 1, 2025

Introduction

The pharmaceutical landscape for INDIUM IN 111 OXYQUINOLINE, a radiopharmaceutical agent primarily utilized in diagnostic imaging procedures, is characterized by evolving market dynamics driven by technological advancements, regulatory developments, and global health trends. Understanding its financial trajectory necessitates a comprehensive analysis of its clinical applications, competitive positioning, supply chain orchestration, and broader healthcare sector influences.

Overview of INDIUM IN 111 OXYQUINOLINE

INDIUM IN 111 OXYQUINOLINE, also known as In-111 pentetreotide or Octreoscan, is a radiolabeled compound designed for somatostatin receptor scintigraphy (SRS). Its primary utility lies in the detection and localization of neuroendocrine tumors, including carcinoids, pancreatic endocrine tumors, and other somatostatin receptor-positive malignancies [1].

The radiopharmaceutical is administered intravenously, emitting gamma radiation detectable by SPECT imaging, facilitating precise tumor localization. The compound's specificity for somatostatin receptor-expressing tissue makes it invaluable in personalized diagnostic pathways.

Market Drivers

Growing Incidence of Neuroendocrine Tumors

The global burden of neuroendocrine tumors (NETs) has increased markedly over the past decade. According to Surveillance, Epidemiology, and End Results (SEER) data, the incidence of NETs has risen approximately 4% annually in the United States, driven by improved detection and awareness [2]. This rise correlates directly with increased demand for targeted imaging agents such as Indium In-111 Oxyquinoline.

Advances in Diagnostic Imaging

The shift toward more precise, non-invasive diagnostic modalities enhances the adoption of radiopharmaceuticals. The integration of SPECT and PET imaging platforms, coupled with innovations in radiolabeling chemistry, augments the clinical utility of In-111 based diagnostics.

Regulatory Approvals and Reimbursement Policies

Regulatory approvals by agencies such as the FDA and EMA underpin market confidence in radiopharmaceuticals. Reimbursement policies across developed countries increasingly recognize the value of functional imaging, incentivizing healthcare providers to adopt agents like In-111 Oxyquinoline [3].

Emerging Alternatives and Competition

While In-111 Oxyquinoline remains prominent, the emergence of PET-based tracers such as Ga-68 DOTATATE offers superior resolution and shorter imaging protocols, creating a competitive dynamic [4]. Nevertheless, In-111's longer half-life and established production infrastructure sustain its relevance.

Market Challenges

Supply Chain and Production Complexity

Radiopharmaceutical manufacturing involves complex logistics, requiring on-site or nearby cyclotrons/radiochemistry facilities. The current reliance on specific technetium or indium isotopes presents supply constraints, particularly during global disruptions like the COVID-19 pandemic.

Regulatory and Safety Concerns

Radiation safety regulations impose strict handling, storage, and disposal procedures. Additionally, the short half-life of In-111 (approximately 2.8 days) demands efficient scheduling, impacting supply predictability.

Cost Considerations

Although clinically valuable, In-111 Oxyquinoline's production and deployment costs influence pricing strategies and reimbursement levels, potentially affecting market penetration in price-sensitive regions.

Financial Trajectory: Historical and Projected Trends

Current Market Valuation

The global radiopharmaceuticals market, valued at approximately USD 5.4 billion in 2022, is projected to grow at a CAGR of 8% through 2030 [5]. In-111 Oxyquinoline accounts for a significant share owing to its established role in neuroendocrine tumor imaging.

Revenue Streams and Growth Opportunities

Key revenue streams derive from diagnostic procedures leveraging In-111 Oxyquinoline, with growth driven by increased diagnostic awareness and expanded healthcare infrastructure. Emerging markets in Asia-Pacific show promising adoption rates, attributable to rising healthcare investments and tumor detection programs.

Investment in R&D and Portfolio Expansion

Pharmaceutical companies are investing in R&D to develop next-generation radiotracers with enhanced specificity, better imaging qualities, and more straightforward logistics. Such innovations could either complement or replace existing agents, modifying revenue streams.

Impact of Competitive Technologies

While technological advances threaten to displace In-111 agents with PET-based alternatives, the latter's limited availability and high infrastructural costs sustain In-111’s market presence, particularly in regions lacking PET facilities.

Forecasted Financial Performance

Analysts project the In-111 radiopharmaceutical segment to grow robustly, driven by increased clinical adoption and broader indications. Revenue from In-111 Oxyquinoline is anticipated to grow at a CAGR of approximately 6-7% over the next five years, influenced by regional expansion, regulatory milestones, and technological enhancements.

Regulatory and Commercial Strategies

To capitalize on market dynamics, companies should prioritize diversified supply chain management, pursue regulatory clearances in emerging markets, and invest in clinical trials demonstrating superior diagnostic accuracy. Strategic partnerships for distribution and manufacturing can mitigate logistical bottlenecks.

Conclusion

The financial trajectory for INDIUM IN 111 OXYQUINOLINE is promising, anchored in rising neuroendocrine tumor incidence, technological evolution, and expanding healthcare infrastructure. Nonetheless, it faces competitive pressures from innovative PET tracers and supply chain complexities. Successful navigation requires a strategic focus on technological differentiation, regulatory agility, and regional market penetration.

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Key Takeaways

• The global increase in neuroendocrine tumors fosters higher demand for specific diagnostic imaging agents like In-111 Oxyquinoline.
• While competition from PET-based tracers intensifies, established supply chains and regulatory familiarity sustain In-111’s market share.
• Supply chain logistics and radiation safety regulations remain critical challenges, influencing costs and availability.
• Growth projections indicate a CAGR of 6-7% over the next five years, with emerging markets presenting substantial expansion opportunities.
• Innovating around supply stability and clinical efficacy will be crucial for maximizing revenue streams and maintaining market relevance.

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FAQs

1. How does In-111 Oxyquinoline compare to PET-based somatostatin receptor imaging agents?
In-111 Oxyquinoline provides effective SPECT imaging with established clinical protocols. PET agents like Ga-68 DOTATATE offer higher resolution and shorter imaging times but require advanced infrastructure and are more costly. Both are used complementary depending on regional capabilities.

2. What are the primary clinical indications for In-111 Oxyquinoline?
It is primarily indicated for localization and staging of neuroendocrine tumors, especially carcinoids and pancreatic endocrine tumors, in cases where high specificity in receptor imaging is required.

3. What factors influence the pricing of In-111 radiopharmaceuticals?
Pricing is influenced by production costs, supply chain logistics, regulatory compliance, and reimbursement policies. The short half-life also introduces logistical costs impacting final prices.

4. Are there ongoing R&D efforts to enhance In-111 based radiopharmaceuticals?
Yes, research focuses on improving targeting specificity, reducing production complexity, and extending shelf life, all to optimize diagnostic accuracy and operational efficiency.

5. How does regional healthcare infrastructure impact the market for In-111 Oxyquinoline?
Regions with advanced nuclear medicine infrastructure see higher adoption rates. In emerging markets, increasing investment and regulatory support are facilitating expanded utilization, though logistical challenges persist in less developed areas.

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Sources
[1] European Journal of Nuclear Medicine and Molecular Imaging, 2021.
[2] SEER Program Data, 2022.
[3] World Journal of Nuclear Medicine, 2020.
[4] Journal of Nuclear Medicine, 2019.
[5] MarketsandMarkets, 2022.