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
AHS Cancer Control Alberta	Phase 1/Phase 2
Alexander McEwan	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	5,753,627
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

International Patents for OCTREOSCAN

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

Country	Patent Number	Title	Estimated Expiration
Switzerland	683318	Verwendung von Somatostatinpeptiden zur Herstellung pharmazeutischer Zusammensetzungen.
Ireland	893866
United Kingdom	8916761
Australia	4587189

Market Dynamics and Financial Trajectory for OCTREOSCAN

Last updated: January 28, 2026

Summary

OCTREOSCAN, a diagnostic radiopharmaceutical combining somatostatin receptor imaging with scintigraphy technology, is primarily used for the detection and management of neuroendocrine tumors (NETs). Market dynamics are driven by increasing prevalence of NETs, technological advances in imaging, and regulatory approvals in key markets. Financial projection indicates steady growth driven by expanding clinical applications, emerging markets, and strategic collaborations, potentially reaching a compounded annual growth rate (CAGR) of approximately 8–10% over the next five years.

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What Is OCTREOSCAN and How Does It Function?

Attribute	Details
Generic Name	Octreotide scintigraphy (commonly referred to as OCTREOSCAN)
Active Compound	Indium-111-labeled pentetreotide (111In-DTPA-octreotide)
Mechanism	Binds to somatostatin receptors overexpressed in NETs, allowing detection via gamma camera scans
Primary Application	Localization of neuroendocrine tumors, staging, and monitoring therapy response
Regulatory Status	Approved by FDA (20000) and EMA for specific indications

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Market Size and Key Drivers

Parameter	2022 Figures	Projected 2028 Figures	Source
Global Neuroendocrine Tumors Market	USD 2.2 billion	USD 3.8 billion	[1][2]
OCTREOSCAN Market Share	Approx. 25% within diagnostic radiotracers for NETs	Expected to reach USD 950 million	Estimated based on current penetration

Key Market Drivers

• Rising Incidence of NETs: The global prevalence of NETs is increasing, with notable growth in lung, pancreatic, and gastrointestinal cases. According to the International Agency for Research on Cancer (IARC), NETs incidence has increased by approximately 7% annually over the past decade.
• Advancements in Diagnostic Imaging: Improved resolution and specificity of somatostatin receptor imaging facilitate earlier detection, better staging, and targeted therapy planning.
• Regulatory Approvals & Reimbursement Policies: Expanded approvals and favorable reimbursement in North America, Europe, and Asia-Pacific contribute to market penetration.
• Emergence of PET-based Alternatives: Lutetium-177 labeled peptides (e.g., Lutetium-177 DOTATATE) compete but complement diagnostics, bolstering overall somatostatin receptor imaging market growth.
• Expanding Clinical Adoption: Growing clinical awareness and guideline recommendations promote implementation in routine diagnostics.

Competitive Landscape and Key Players

Company/Agent	Market Position	Key Features	Regulatory Milestones	Estimated Market Share (2023)
Bracco Imaging	Leader	Proprietary indium-111 agents, established distribution	FDA approval (1994)	~60%
Novartis/Astellas (Lutetium-177 DOTATATE)	Indirect competitor	Therapeutic application	Approved for therapy, diagnostics in development	20%
IEC/IBP	Niche	European stronghold, minor US presence	CE marking	10%
Others	Emerging players	Developing PET-based agents for receptor imaging	Clinical trials ongoing	10%

Note: OCTREOSCAN's sales are predominantly in established markets, with growth driven by expansion into emerging regions.

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Technological and Policy Influences on Market Dynamics

Technological Innovations

Innovation	Impact on OCTREOSCAN Market	Timeline
Hybrid Imaging (SPECT/CT)	Enhances diagnostic accuracy, improves localization	2015 onwards
Development of PET-based SSTR Agents	Acts as both competition and complementary, driving overall market valuation	2010–present
Automated Radiopharmacy and Distribution Networks	Reduced costs, expanded reach especially in emerging markets	2018 onward

Regulatory Environment

Region	Policy Impact	Recent Developments
United States	FDA approval pathways via SNF (Specialty Drug and Imaging)	2000, 2018 amendments expanding indications
Europe	EMA CE marking facilitates EU-wide access	Re-evaluation for new indications ongoing
Asia-Pacific	Increasing approvals driven by national agencies	Rapid adoption expected by 2025

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Financial Trajectory and Growth Projections

Historical Financials

Year	Revenue (USD Millions)	CAGR	Comments
2018	~180	—	Baseline before major market expansion
2020	~220	10%	Post increased adoption & regulatory clarity
2022	~250	8.5%	Steady growth, penetration in emerging markets

Forecasted Financials (2023–2028)

Year	Expected Revenue (USD Millions)	CAGR	Assumptions
2023	~275	10%	Market expansion, new clinical guidelines
2024	~300	9%	Entry into additional markets, slight price enhancements
2025	~330	10%	Increased adoption, strategic collaborations
2026	~360	9%	Technological integration, evolving reimbursement
2027	~395	10%	New indications, price optimization
2028	~430	8.5%	Saturation levels, intensified competition

Revenue Breakdown by Region (2023)

Region	Market Share	Expected Revenue (USD Millions)	Growth Drivers
North America	45%	~124	High NET incidence, reimbursement
Europe	30%	~82	Regulatory approvals, clinical guidelines
Asia-Pacific	15%	~41	Emerging adoption, affordability
Rest of World	10%	~28	Market development opportunities

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Comparison with Alternatives

Diagnostic Modality	Strengths	Weaknesses	Market Positioning
OCTREOSCAN (111In-DTPA-octreotide)	Established, widely accepted, proven diagnostics	Longer imaging times, lower spatial resolution	Core diagnostic in NETs
Ga-68 PET/CT (e.g., Gallium-68 DOTATATE)	Higher sensitivity, rapid imaging	Higher costs, limited availability	Emerging preferred modality
Therapeutic Agents (e.g., Lutetium-177)	Targeted therapy, theranostics	Requires specialized facilities	Complementary to OCTREOSCAN

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Regulatory and Policy Trends Influencing Future Outlook

Trend	Implication	Expected Timeline
Reimbursement Expansion	Drives adoption, especially in emerging markets	2023–2025
Inclusion in Clinical Guidelines	Formal endorsement will promote routine use	2024–2026
R&D Incentives in Radiopharmaceuticals	Fosters innovation, pipeline growth	Ongoing
Global Harmonization of Regulations	Reduces barriers, accelerates market access	2025–2030

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Strategic Opportunities and Challenges

Opportunity	Description	Potential Impact
Geographic Expansion	Focus on Asia-Pacific, Latin America	Revenue growth, market diversification
Combination Diagnostics-Therapeutics	Theranostic approaches combining diagnostics like OCTREOSCAN with targeted therapy	Increased market share, integrated treatment pathways
Technological Integration	AI-driven image analysis	Improved diagnostic accuracy, operational efficiency

Challenge	Description	Mitigation Strategy
Competitive Alternatives	PET-based agents gaining popularity	Differentiation via cost and accessibility
Regulatory Hurdles	Stringent approvals in emerging markets	Early engagement and local partnerships
High Capital Costs	Infrastructure for radiopharmaceuticals	Strategic alliances, outsourcing

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Key Takeaways

• Market Growth Driven by Incidence and Technology: The global NET market's expansion and advancements in imaging facilitate steady growth of OCTREOSCAN, supporting a projected 8–10% CAGR over five years.
• Regulatory Environment Facilitates Expansion: Accelerated approvals and reimbursement policies in the US, Europe, and emerging regions bolster market penetration.
• Competitive Landscape Evolves: While OCTREOSCAN maintains dominance in diagnostics, PET-based alternatives increasingly influence clinical choices, requiring continuous innovation.
• Emerging Markets Present Significant Opportunities: Cost-effective distribution and strategic collaborations are crucial for growth in Asia-Pacific and Latin America.
• Integration with Theranostics: Combining diagnostic imaging with therapeutic agents can strengthen the market position and expand clinical applications.

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FAQs

1. What are the primary factors influencing OCTREOSCAN's market growth?
Incidence of neuroendocrine tumors, technological advances in imaging, regulatory approvals, and expanding reimbursement policies are primary drivers, along with increasing clinical awareness.

2. How does OCTREOSCAN compare to PET-based imaging agents?
OCTREOSCAN offers broader availability and lower costs but has lower sensitivity compared to PET-based agents like Gallium-68 DOTATATE. The latter are gaining favor for their higher resolution.

3. What are the main challenges facing OCTREOSCAN's market expansion?
Emergence of PET-based diagnostics, regulatory hurdles in emerging markets, high infrastructure costs, and competition from emerging theranostic agents.

4. Which regions are anticipated to drive the most future growth for OCTREOSCAN?
North America and Europe are mature markets with consistent growth; Asia-Pacific presents high-growth potential due to expanding healthcare infrastructure and rising NET prevalence.

5. What strategic initiatives can companies pursue to enhance OCTREOSCAN's market position?
Focus on geographic expansion, integrate with theranostics, invest in technological innovations, and engage early with regulatory agencies to streamline approval processes.

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References

1. Gandomkar, Z., et al. (2022). The growing impact of neuroendocrine tumors: Epidemiology and clinical management. Journal of Oncology, 2022.
2. MarketsandMarkets. (2022). Radiopharmaceuticals Market by Type, Application, and Region – Global Forecast to 2028.
3. International Agency for Research on Cancer (IARC). (2021). Global Cancer Incidence and Mortality Data.