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
Patent Applications:	102
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	5,310,912

International Patents for DATSCAN

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0831941	NEUROSONDES IODEES POUR CARTOGRAPHIER LES SITES DE REABSORPTION DE LA MONOAMINE (IODINATED NEUROPROBES FOR MAPPING MONOAMINE REUPTAKE SITES)
Finland	956261
Australia	4655493
Australia	6159796
Japan	3731005
European Patent Office	0703791	NEUROSONDE IODEE DESTINEE A LA CARTOGRAPHIE DE SITES DE REABSORPTION DE MONOAMINES (AN IODINATED NEUROPROBE FOR MAPPING MONOAMINE REUPTAKE SITES)
Finland	120183

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	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
0703791	300123	Netherlands
0703791	03C0021	France		PRODUCT NAME: IOFLUPANE (123 I); REGISTRATION NO/DATE: EU/1/00/135/001 20000727
0703791	C300123	Netherlands		PRODUCT NAME: IOFLUPANE (123I); NAT. REGISTRATION NO/DATE: EU/1/00/135/001 20000727; FIRST REGISTRATION: EU/1/00/135/001 20000727

DATSCAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DaTSCAN

Introduction

DaTSCAN, a diagnostic radiopharmaceutical developed by GE Healthcare, is used for the visualization of functional striatal dopamine transporter using single photon emission computed tomography (SPECT) brain imaging. This article delves into the market dynamics and financial trajectory of DaTSCAN, highlighting its approval, market performance, and future prospects.

Approval and Regulatory Framework

DaTSCAN, containing the medicinal ingredient 123I-Ioflupane, has been approved by several regulatory bodies, including the US FDA and Health Canada. In the US, it was approved in November 2022 to help evaluate adult patients with suspected Parkinsonian disorders[1][5].

Health Canada granted a Notice of Compliance for DaTSCAN on December 7, 2017, after a thorough review of its safety, efficacy, and quality. The approval process involved several milestones, including a pre-submission meeting and a critical assessment of the data package submitted by the sponsor[5].

Market Size and Growth

The radiopharmaceuticals market, within which DaTSCAN operates, is projected to experience significant growth. The global radiopharmaceuticals market is expected to surpass USD 13.67 billion by 2032, growing at a CAGR of 10.2% from 2023 to 2032[1].

Segment Performance

DaTSCAN falls under the diagnostic segment of radiopharmaceuticals, which accounted for almost 67% of the revenue share in 2022. This segment is expected to continue its dominance, although the therapeutics segment is predicted to grow at the fastest CAGR over the anticipated period[1].

Radioisotope Segment

The technetium-99m segment, while dominant in 2022 with a 45% revenue share, is not directly related to DaTSCAN, which uses Ioflupane I 123. However, the Gallium-68 segment, another growing area, is expected to rise at a notable CAGR of 13.1%, indicating a broader growth trend in the radiopharmaceutical market[1].

Application and End-User Dynamics

DaTSCAN is primarily used in the evaluation of adult patients with suspected Parkinsonian disorders. The cancer division, although not directly related to DaTSCAN's primary use, accounted for more than 53% of the revenue share in the radiopharmaceuticals market in 2022. However, the cardiology segment is expected to grow at the fastest CAGR, reflecting broader market trends[1].

End-User Segments

Hospitals and clinics held a significant revenue share of more than 52% in 2022. Medical imaging centers, where DaTSCAN is often used, are expected to rise at an impressive 14.8% CAGR during the forecast period, indicating growing demand for diagnostic services[1].

Regional Market Performance

North America, with its strong healthcare ecosystem, numerous R&D projects, and high prevalence of chronic illnesses, dominated the radiopharmaceuticals market with a 44% market share in 2022. The region's well-established regulatory environment, advantageous reimbursement systems, and concentration of top pharmaceutical and radiopharmaceutical companies further solidify its leadership[1].

The Asia-Pacific region is predicted to experience the fastest rate of growth due to its large and ageing population, improvements in healthcare infrastructure, and increased R&D expenditures. This growth is likely to benefit the overall radiopharmaceutical market, including diagnostic agents like DaTSCAN[1].

Cost-Effectiveness and Clinical Impact

Studies have shown that DaTSCAN is cost-effective in the diagnostic workup of patients with uncertain parkinsonism. A cost-effectiveness analysis from the Belgian healthcare system indicated that the use of DaTSCAN resulted in a change of management in 48.5% of patients and gained 1.2 adequately treated years per patient at a marginal additional cost[4].

Clinical Benefits

DaTSCAN has been found to have a significant and favourable impact on patient management. It helps in early diagnosis and appropriate treatment, leading to cost savings and improved patient outcomes. For instance, in the Italian healthcare system, the use of DaTSCAN was estimated to generate cost savings and gain 1.8 years on potentially beneficial therapy per patient[4].

Financial Trajectory

The financial performance of DaTSCAN is closely tied to the broader radiopharmaceuticals market. With the market projected to grow significantly, DaTSCAN is likely to benefit from increased demand for diagnostic radiopharmaceuticals.

Revenue Projections

While specific revenue projections for DaTSCAN are not available, the growth of the diagnostic segment and the increasing use of radiopharmaceuticals in neurology and other fields suggest a positive financial trajectory. The approval of DaTSCAN by regulatory bodies and its inclusion in clinical guidelines further support its market potential.

Key Players and Competitive Landscape

GE Healthcare, the developer of DaTSCAN, is a major player in the radiopharmaceutical market. The company's strong presence in the healthcare sector, along with its commitment to R&D and technological advancements, positions it well to capitalize on the growing demand for radiopharmaceuticals[1].

Market Drivers

Several factors drive the market for DaTSCAN and radiopharmaceuticals in general. These include:

• Regulatory Approvals: Recent approvals, such as the FDA approval of DaTSCAN, enhance market confidence and adoption.
• Technological Advancements: Improvements in imaging modalities and diagnostic techniques increase the demand for radiopharmaceuticals.
• Increasing Prevalence of Chronic Illnesses: The rising incidence of chronic diseases, particularly in ageing populations, fuels the need for diagnostic and therapeutic radiopharmaceuticals[1].

Conclusion

DaTSCAN, as a diagnostic radiopharmaceutical, operates within a rapidly growing market driven by technological advancements, regulatory approvals, and increasing healthcare needs. Its cost-effectiveness, clinical benefits, and strong regulatory backing position it for continued growth and financial success.

Key Takeaways

• Market Growth: The global radiopharmaceuticals market is projected to surpass USD 13.67 billion by 2032.
• Diagnostic Segment: DaTSCAN falls under the diagnostic segment, which accounted for almost 67% of the revenue share in 2022.
• Regional Dominance: North America dominates the market, but the Asia-Pacific region is expected to experience the fastest growth.
• Cost-Effectiveness: DaTSCAN is cost-effective in the diagnostic workup of patients with uncertain parkinsonism.
• Clinical Impact: It has a significant and favourable impact on patient management and outcomes.

FAQs

What is DaTSCAN used for?

DaTSCAN is used for the visualization of functional striatal dopamine transporter using SPECT brain imaging, primarily to evaluate adult patients with suspected Parkinsonian disorders.

Who approved DaTSCAN?

DaTSCAN has been approved by regulatory bodies such as the US FDA and Health Canada.

What is the projected growth of the radiopharmaceuticals market?

The global radiopharmaceuticals market is expected to surpass USD 13.67 billion by 2032, growing at a CAGR of 10.2% from 2023 to 2032.

Which segment dominates the radiopharmaceuticals market?

The diagnostic segment, where DaTSCAN is categorized, accounted for almost 67% of the revenue share in 2022.

What are the key drivers of the radiopharmaceuticals market?

Key drivers include regulatory approvals, technological advancements, and the increasing prevalence of chronic illnesses.

Sources

1. Biospace: Radiopharmaceuticals Market Size to Surpass USD 13.67 Bn by 2032
2. Hendrick Health: Hendrick announces imaging agent availability for Parkinson's or ...
3. GE HealthCare: GE HealthCare Investor Day Presentation
4. Parkinson's UK: Is DaTSCAN cost-effective as a diagnostic tool in uncertain ...
5. Health Canada: Summary Basis of Decision for DaTscan