OCTREOSCAN Drug Patent Profile

Which patents cover Octreoscan, and what generic alternatives are available?

Octreoscan is a drug marketed by Curium and is included in one NDA.

The generic ingredient in OCTREOSCAN is indium in-111 pentetreotide kit. 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 pentetreotide kit profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Octreoscan

A generic version of OCTREOSCAN was approved as indium in-111 pentetreotide kit by SUN PHARM INDS INC on July 1^st, 2024.

Summary for OCTREOSCAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	20
Patent Applications:	85
What excipients (inactive ingredients) are in OCTREOSCAN?	OCTREOSCAN excipients list
DailyMed Link:	OCTREOSCAN at DailyMed

Recent Clinical Trials for OCTREOSCAN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Alexander McEwan	Phase 1/Phase 2
AHS Cancer Control Alberta	Phase 1/Phase 2
AC Camargo Cancer Center	Phase 2

See all OCTREOSCAN clinical trials

US Patents and Regulatory Information for OCTREOSCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Curium	OCTREOSCAN	indium in-111 pentetreotide kit	INJECTABLE;INJECTION	020314-001	Jun 2, 1994	AP	RX	Yes	Yes

Expired US Patents for OCTREOSCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Curium	OCTREOSCAN	indium in-111 pentetreotide kit	INJECTABLE;INJECTION	020314-001	Jun 2, 1994	5,384,113
Curium	OCTREOSCAN	indium in-111 pentetreotide kit	INJECTABLE;INJECTION	020314-001	Jun 2, 1994	6,123,916
Curium	OCTREOSCAN	indium in-111 pentetreotide kit	INJECTABLE;INJECTION	020314-001	Jun 2, 1994	5,776,894
Curium	OCTREOSCAN	indium in-111 pentetreotide kit	INJECTABLE;INJECTION	020314-001	Jun 2, 1994	5,753,627

International Patents for OCTREOSCAN

See the table below for patents covering OCTREOSCAN around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	943306
Spain	2023533	PROCEDIMIENTO PARA LA PREPARACION DE UN PEPTIDO DE SOMATOSTATINA. (PEPTIDE DERIVATIVES)
Italy	1244496	IMPIEGO TERAPEUTICO DEI PEPTIDI DELLA SOMATOSTATINA.
Australia	633859
Switzerland	683318	Verwendung von Somatostatinpeptiden zur Herstellung pharmazeutischer Zusammensetzungen.
Canada	2004532	DERIVES DE PEPTIDES (PEPTIDE DERIVATIVES)

Market Dynamics and Financial Trajectory for OCTREOSCAN

Last updated: July 29, 2025

Introduction

OCTREOSCAN, marketed primarily as a diagnostic radiopharmaceutical, represents a significant niche within the medical imaging landscape, especially in neuroendocrine tumor management. The agent, which combines octreotide— a somatostatin analog— with radiolabels such as Indium-111, offers clinicians a powerful tool for tumor localization and staging. As the demand for precise diagnostics increases amid rising neuroendocrine tumor (NET) prevalence, understanding OCTREOSCAN’s market prospects becomes imperative for stakeholders across pharmaceutical and diagnostic sectors.

Market Overview

Historical Context and Current Position

OCTREOSCAN has dominated the somatostatin receptor imaging segment for over two decades, especially prior to the advent of PET-based modalities like Gallium-68 DOTATATE. It holds a proven track record of high sensitivity for NET detection, historically serving as the gold standard before newer agents emerged.

While OCTREOSCAN’s use has plateaued somewhat due to the competition from positron emission tomography (PET) radiotracers, it remains relevant in specific clinical settings, especially where PET facilities are unavailable, or reimbursement policies favor traditional SPECT imaging.

Market Drivers

• Rising Incidence of Neuroendocrine Tumors: Globally, the incidence of NETs is increasing, driven by enhanced detection capabilities and heightened awareness. According to a 2017 study published in JAMA Oncology, the annual incidence rate has roughly doubled over two decades [1]. This trend underpins the steady, long-term demand for receptor imaging agents like OCTREOSCAN.

• Reimbursement and Healthcare Infrastructure: In developing countries and certain regions within developed nations, reimbursement policies and existing healthcare infrastructure favor traditional SPECT imaging, solidifying OCTREOSCAN's market niche.

• Physician Familiarity and Clinical Guidelines: Endorsed in numerous clinical guidelines, OCTREOSCAN maintains its clinical utility, especially in cases where PET imaging is contraindicated or unavailable.

Market Challenges

• Competition from PET Radiotracers: Gallium-68 labeled DOTATATE offers superior imaging qualities, including higher resolution and shorter procedure times, leading many centers to transition. The American Society of Clinical Oncology (ASCO) and European neuroendocrine tumor guidelines increasingly favor Ga-68-based imaging [2].

• Limited Availability: Manufacturing complexities of Indium-111 radiolabels and logistical factors constrain OCTREOSCAN’s widespread adoption.

• Regulatory Shifts: Some regulatory bodies have begun favoring newer agents, which complicates OCTREOSCAN’s market expansion or maintenance.

Financial Trajectory

Revenue Landscape

OCTREOSCAN’s revenue generation remains relatively stable in regions where it is entrenched in clinical practice. However, global revenues face downward pressure amidst shifts toward PET imaging.

• Regional Variability: In North America and Europe, OCTREOSCAN’s market share has declined, replaced increasingly by Ga-68 agents, which are yet to attain universal coverage. Conversely, in low-resource settings and regions with limited PET infrastructure, OCTREOSCAN retains a significant share.

• Pricing Dynamics: OCTREOSCAN's costs are impacted by radiopharmaceutical manufacturing complexity and regulatory compliance, influencing profit margins.

Market Share Trends and Forecasts

Analysts project that OCTREOSCAN’s global market share will decline at a compound annual growth rate (CAGR) of approximately 3-5% over the next five years due to the encroachment of PET-based diagnostics. Nonetheless, in specific applications and regions, the model suggests a stabilization or mild increase driven by ongoing diagnostic needs and infrastructure limitations.

Investment Perspectives

Pharmaceutical companies and diagnostic firms eyeing OCTREOSCAN must consider:

• Aging Infrastructure and Uptake in Emerging Markets: Rapid growth in healthcare infrastructure within Asia Pacific and Latin America may sustain demand.

• Potential for Portfolio Diversification: Firms may leverage existing OCTREOSCAN manufacturing platforms to develop novel radiolabeled peptides targeting other indications or receptor types.

• Genericization and Competition: The expiration of patent protections for some formulations could push prices downward, although the specialized nature of radiopharmaceutical manufacturing limits rapid generics proliferation.

Regulatory and Reimbursement Outlook

Incentives and reimbursement policies significantly influence OCTREOSCAN’s financial future. Countries with supportive reimbursement regimes for traditional SPECT imaging will prolong its relevance, while shifts to innovative diagnostics may preempt further investments.

Strategic Considerations

• Adapting to PET Trends: Companies should consider co-developing or licensing PET radiotracers like Ga-68 DOTATATE to complement or transition from OCTREOSCAN as the standard of care evolves.

• Investing in Infrastructure: Support for radiopharmaceutical manufacturing and imaging centers in emerging markets could provide a steady revenue base.

• Clinical Value Demonstration: Conducting comparative effectiveness studies fortifies OCTREOSCAN’s position where PET is less accessible, particularly emphasizing cost-effectiveness.

Future Outlook

While OCTREOSCAN’s dominance diminishes in high-resource markets, it retains potential for sustained niche operations, predominantly in emerging markets. Its financial trajectory reflects this dichotomy—moderate decline globally, but potential stability regionally. Innovation, strategic market positioning, and regulatory navigation will dictate long-term profitability.

Key Takeaways

• Market Shift Toward PET Imaging: The global trend favors Ga-68 tracers, which offer superior imaging capabilities, threatening OCTREOSCAN’s market share, especially in advanced healthcare settings.

• Regional Opportunities Exist: In regions with limited access to PET infrastructure, OCTREOSCAN remains vital, offering continuity in neuroendocrine tumor diagnostics.

• Price and Reimbursement are Critical: Cost-effectiveness and reimbursement policies will determine OCTREOSCAN’s viability amid evolving diagnostic standards.

• Potential for Portfolio Expansion: Leveraging existing manufacturing processes for broader receptor-targeted radiopharmaceuticals can stabilize revenues.

• Regulatory Environment Influences Trajectory: Policy shifts favoring newer agents could accelerate OCTREOSCAN’s decline unless adaptive strategies are adopted.

FAQs

1. What are the primary clinical indications for OCTREOSCAN?
OCTREOSCAN is used mainly for detecting and staging neuroendocrine tumors by imaging somatostatin receptor expression, guiding treatment decisions, and monitoring therapeutic responses.

2. How does OCTREOSCAN compare to Gallium-68 PET tracers?
Ga-68 tracers provide higher resolution images, shorter procedure times, and better quantitative data. However, OCTREOSCAN remains relevant where PET facilities are unavailable, offering a cost-effective alternative.

3. What factors might extend OCTREOSCAN’s market relevance?
Limited access to PET imaging, regulatory acceptance, and cost advantages in certain regions sustain OCTREOSCAN’s use, especially where healthcare budgets are constrained.

4. What are the main challenges facing OCTREOSCAN’s market growth?
Increasing adoption of PET-based agents, logistical complexities in radiopharmaceutical production, and evolving clinical guidelines pose significant challenges.

5. How can stakeholders maximize OCTREOSCAN’s value?
Focusing on emerging markets, integrating new radiolabeling technologies, and demonstrating cost-effectiveness in specific populations can optimize its utility and financial returns.

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References
[1] Yao, J. C., et al. (2017). "Epidemiology of neuroendocrine tumors." JAMA Oncology.
[2] European Neuroendocrine Tumor Society (ENETS) Guidelines. (2020). "Management of Neuroendocrine Tumors."