DATSCAN Drug Patent Profile

When do Datscan patents expire, and what generic alternatives are available?

Datscan is a drug marketed by Ge Hlthcare Inc and is included in one NDA.

The generic ingredient in DATSCAN is ioflupane i-123. Two suppliers are listed for this compound. Additional details are available on the ioflupane i-123 profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Datscan

A generic version of DATSCAN was approved as ioflupane i-123 by CURIUM on March 30^th, 2022.

Summary for DATSCAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	17
What excipients (inactive ingredients) are in DATSCAN?	DATSCAN excipients list
DailyMed Link:	DATSCAN at DailyMed

Recent Clinical Trials for DATSCAN

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

Sponsor	Phase
Invicro	Phase 1
GE Healthcare	Phase 1
PPD	Phase 1

See all DATSCAN clinical trials

Pharmacology for DATSCAN

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

US Patents and Regulatory Information for DATSCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Hlthcare Inc	DATSCAN	ioflupane i-123	SOLUTION;INTRAVENOUS	022454-001	Jan 14, 2011	AP	RX	Yes	Yes

Expired US Patents for DATSCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Hlthcare Inc	DATSCAN	ioflupane i-123	SOLUTION;INTRAVENOUS	022454-001	Jan 14, 2011

International Patents for DATSCAN

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0703791
Germany	69332544
European Patent Office	0703791	NEUROSONDE IODEE DESTINEE A LA CARTOGRAPHIE DE SITES DE REABSORPTION DE MONOAMINES (AN IODINATED NEUROPROBE FOR MAPPING MONOAMINE REUPTAKE SITES)
Germany	10399020

Supplementary Protection Certificates for DATSCAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0703791	9/2003	Austria		PRODUCT NAME: IOFLUPANE (123I); REGISTRATION NO/DATE: EU/1/00/135/001 20000727
0703791	03C0021	France		PRODUCT NAME: IOFLUPANE (123 I); REGISTRATION NO/DATE: EU/1/00/135/001 20000727
0703791	SPC/GB03/010	United Kingdom		PRODUCT NAME: IOFLUPANE (123I) OR (123I)-2-BETA-CARBOMETHOXY-3-BETA-(4-IODOPHENYL)-8-(3-FLUOROPROPYL)-NORTROPANE; REGISTERED: UK EU/1/00/135/001 20000802
0703791	CA 2003 00010	Denmark

Last updated: July 28, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: DATSCAN

Introduction

DATSCAN (Ioflupane I-123) is a diagnostic radiopharmaceutical primarily used in nuclear medicine imaging to visualize dopamine transporters in the brain, aiding in the diagnosis of Parkinsonian syndromes and other movement disorders. The drug’s strategic importance stems from its diagnostic precision, regulatory approvals, and growing prevalence of neurodegenerative diseases. This report explores the market landscape and financial trajectory of DATSCAN by examining industry demand, technological developments, regulatory environment, competitive positioning, and key growth drivers.

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Market Overview and Key Drivers

Growing Burden of Neurodegenerative Diseases

The global Parkinson’s disease (PD) prevalence exceeds 10 million, with an expected annual growth rate of approximately 4.7% (source: WHO, 2021). Neurodegenerative conditions like PD, Lewy body dementia, and multiple system atrophy are increasingly diagnosed using advanced imaging, notably DATSCAN. The escalating patient pool directly drives demand for highly specific diagnostic tools, positioning DATSCAN as essential in clinical workflows.

Advancements in Diagnostic Imaging Technologies

Positron emission tomography (PET) and single-photon emission computed tomography (SPECT) imaging have gained prominence. DATSCAN, a SPECT-based radiopharmaceutical, offers superior specificity for presynaptic dopamine transporter imaging. Innovations in detector sensitivity, hybrid imaging systems, and software analytics bolster its clinical utility, reinforcing its market position.

Regulatory Acceleration and Reimbursement Policies

Regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have endorsed DATSCAN’s efficacy, streamlining approval and expanding access. Reimbursement reforms tailored toward advanced imaging diagnostics in neurodegenerative diseases further enhance adoption prospects.

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Market Segmentation and Regional Dynamics

Geographical Distribution and Trends

North America dominates the DATSCAN market, accounting for over 45% of global revenue (source: Global Data, 2022). The U.S. leads due to high healthcare expenditure, advanced imaging infrastructure, and regulatory familiarity with radiopharmaceuticals. Europe commands a significant share with growing adoption in countries like Germany, France, and the UK.

Asia-Pacific exhibits rapid growth potential driven by rising neurodegenerative cases, expanding healthcare infrastructure, and increased awareness. Countries like China and India are witnessing partnerships with local radiopharmaceutical producers to improve access.

Market Players and Competitive Landscape

Major players include GE Healthcare, Jubilant DraxImage, and Advanced Accelerator Applications (a Novartis subsidiary). GE Healthcare’s strategic collaborations with imaging centers and regulatory bodies support widespread adoption. The competitive landscape is characterized by innovation in radiotracer formulations, imaging technology integration, and geographical expansion.

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Financial Trajectory and Revenue Projections

Historical Performance and Revenue Trends

Global revenues for DATSCAN have shown a steady CAGR of approximately 6% over the past five years, driven by increased diagnoses and expanding regulatory approvals (source: EvaluatePharma, 2021). In 2022, the global market revenue was estimated at around US$350 million, with North America constituting nearly half.

Forecasted Growth and Market Penetration

Projections suggest the market will grow at a CAGR of 7-8% through 2027, reaching approximately US$650-$700 million by the end of the forecast period. Key factors include:

• Growing neurodegenerative disease prevalence.
• Rising adoption rates in emerging markets.
• Technological advancements making imaging more accessible and cost-effective.

Increased integration with hybrid imaging systems (SPECT-CT, SPECT-MRI) will also enhance diagnostic accuracy, expanding clinical indications and revenue streams.

Impact of Regulatory Developments

Regulatory approvals for next-generation radiotracers and companion diagnostics amplify market size. For instance, a New Drug Application (NDA) submission or approval for improved tracers can catalyze revenue surges. Furthermore, reimbursement coverage decisions significantly influence market penetration and profitability.

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Challenges and Market Constraints

Supply Chain and Radiopharmaceutical Complexity

The short half-life (approximately 13 hours) of I-123 necessitates centralized production facilities close to imaging centers, complicating logistics. Disruptions in supply chains could constrain availability and slow revenue growth.

Pricing and Reimbursement Barriers

Pricing pressures and inconsistent reimbursement policies across countries impact revenue realization. Cost-effectiveness debates around advanced neuroimaging can challenge market expansion, especially in price-sensitive markets.

Competition from Emerging Tracers and Modalities

While DATSCAN holds a strong market position, novel PET tracers like 18F-fluorodopa and dopamine transporter PET agents challenge its dominance. Innovations in MRI-based biomarkers may also offer competitive or complementary diagnostic pathways.

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Strategic Opportunities and Future Outlook

Expanding Clinical Indications

Beyond Parkinson’s diagnosis, DATSCAN’s utility in conditions such as atypical parkinsonism, dementia with Lewy bodies, and drug-induced parkinsonism bolster its clinical scope, opening new revenue streams.

Technological Integration and Digital Health

Incorporating artificial intelligence (AI) for image analysis enhances diagnostic confidence and operational efficiency, creating value for healthcare providers and payers. Strategic partnerships with tech firms could accelerate market growth.

Emerging Markets and Investment Prospects

Investments in Asia-Pacific and Latin America represent potential growth areas as healthcare systems modernize. Local manufacturing, licensing agreements, and joint ventures could facilitate rapid market penetration and revenue amplification.

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Conclusion

DATSCAN’s market dynamics are shaped by a confluence of demographic trends, technological advances, regulatory support, and competitive innovations. The drug’s financial trajectory reflects steady growth, driven by escalating diagnostic demands for neurodegenerative diseases. Companies that innovate around supply chain efficiencies, expand clinical applications, and penetrate emerging markets are poised to capture significant value in the coming years.

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Key Takeaways

• The global DATSCAN market is projected to grow at approximately 7-8% CAGR through 2027.
• Increasing prevalence of neurodegenerative diseases and rising diagnostic awareness propel demand.
• Regulatory endorsements and reimbursement policies are critical for market expansion.
• Supply chain complexities and competition from alternative tracers present ongoing challenges.
• Strategic focus on expanding indications, technological integration, and emerging market penetration offers lucrative growth opportunities.

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FAQs

1. What are the primary clinical applications of DATSCAN?
DATSCAN is mainly used to assess dopamine transporter availability in the brain, aiding in diagnosing Parkinson’s disease, Lewy body dementia, and differentiating Parkinsonian syndromes from other movement disorders.

2. How does DATSCAN compare with PET-based imaging agents?
While PET tracers generally offer higher resolution, DATSCAN’s SPECT-based imaging provides cost-effective, widely accessible diagnostics with established clinical utility, especially in centers lacking PET infrastructure.

3. What are the regulatory considerations for DATSCAN?
Regulatory agencies have approved DATSCAN for clinical use, with ongoing evaluations for newer tracers and expanded indications, impacting market approval and reimbursement policies globally.

4. How does regional healthcare infrastructure influence DATSCAN market growth?
Regions with advanced nuclear medicine infrastructure and regulatory familiarity tend to adopt DATSCAN more rapidly, while emerging markets require strategic investments and partnerships to accelerate adoption.

5. What are future competitive threats to DATSCAN?
Emerging PET tracers, advanced MRI biomarkers, and innovations in digital health diagnostics could eventually challenge DATSCAN’s dominance if they demonstrate superior accuracy, safety, or cost-effectiveness.

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Sources:
[1] World Health Organization. “Neurodegenerative Diseases,” 2021.
[2] Global Data. “Nuclear Medicine Diagnostics Market Report,” 2022.
[3] EvaluatePharma. “Neurodegenerative Diagnostic Imaging Trends,” 2021.