IOFLUPANE I-123 - Generic Drug Details

What are the generic sources for ioflupane i-123 and what is the scope of freedom to operate?

Ioflupane i-123 is the generic ingredient in two branded drugs marketed by Ge Hlthcare Inc and Curium, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for IOFLUPANE I-123

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	8
Patent Applications:	222
What excipients (inactive ingredients) are in IOFLUPANE I-123?	IOFLUPANE I-123 excipients list
DailyMed Link:	IOFLUPANE I-123 at DailyMed

Recent Clinical Trials for IOFLUPANE I-123

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

Sponsor	Phase
GE Healthcare	Phase 1
PPD	Phase 1
PPD	Phase 3

See all IOFLUPANE I-123 clinical trials

Pharmacology for IOFLUPANE I-123

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

US Patents and Regulatory Information for IOFLUPANE I-123

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Curium	IOFLUPANE I-123	ioflupane i-123	SOLUTION;INTRAVENOUS	213792-001	Mar 30, 2022	AP	RX	No	No
Ge Hlthcare Inc	DATSCAN	ioflupane i-123	SOLUTION;INTRAVENOUS	022454-001	Jan 14, 2011	AP	RX	Yes	Yes

Expired US Patents for IOFLUPANE I-123

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

IOFLUPANE I-123 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ioflupane I-123

Introduction

Ioflupane I-123, marketed under the trade name DaTSCAN, is a radiopharmaceutical used in single-photon emission computed tomography (SPECT) brain imaging to diagnose and differentiate Parkinsonian syndromes from other movement disorders. Here, we delve into the market dynamics and financial trajectory of this critical diagnostic tool.

Market Need and Demand

The demand for Ioflupane I-123 is driven by the increasing prevalence of Parkinsonian syndromes, which affect approximately 1% of the population over the age of 65. This demographic is growing, leading to an increased need for accurate diagnostic tools[4].

Regulatory Approvals

Ioflupane I-123 has received regulatory approvals in several regions. It was first approved in the EU in 2000 and later in the U.S. by the FDA. A significant milestone was the approval of a generic version by Curium in March 2022, which expanded market access and competition[1][4].

Market Competition

The approval of a generic version of DaTSCAN by Curium has introduced competition into the market, potentially affecting the pricing and market share of the original product. This competition can lead to better pricing for healthcare providers and patients, making the diagnostic tool more accessible[4].

Pricing and Reimbursement

The pricing of Ioflupane I-123 can vary based on the region and the specific product (branded vs. generic). The introduction of a generic version is expected to reduce costs, making it more affordable for a wider range of patients. Reimbursement policies also play a crucial role, with many healthcare systems covering the costs of this diagnostic procedure due to its critical role in diagnosing Parkinsonian syndromes[4].

Distribution and Availability

Ioflupane I-123 is available worldwide, with Curium's generic version now available in the U.S. market. The distribution strategy includes supplying the solution ready to inject, which simplifies the process for healthcare providers. The ability to scan patients on various days, including early mornings, adds flexibility to the scheduling of this important diagnostic study[4].

Financial Performance

The financial performance of Ioflupane I-123 is influenced by several factors, including the number of diagnoses, market competition, and regulatory approvals. The approval of a generic version is likely to impact the revenue of the branded product, but overall demand for the diagnostic tool is expected to remain strong due to the growing prevalence of Parkinsonian syndromes.

Revenue Projections

Given the increasing demand and the expanded market access due to generic competition, revenue projections for Ioflupane I-123 are likely to remain stable or see a slight increase. The generic version may capture a significant share of the market, but the overall market size is expected to grow as more patients are diagnosed and treated.

Cost Structure

The cost structure includes the production costs of the radiopharmaceutical, distribution expenses, and regulatory compliance costs. The generic version may have a lower cost structure, which could lead to better margins for the generic manufacturer.

Market Trends

Several trends are shaping the market for Ioflupane I-123:

Increasing Prevalence of Parkinsonian Syndromes

The growing number of patients with Parkinsonian syndromes is a key driver of demand for this diagnostic tool[4].

Advancements in Diagnostic Imaging

Advancements in SPECT technology and the development of new radiopharmaceuticals are enhancing the accuracy and efficiency of diagnostic procedures.

Regulatory Environment

Regulatory approvals and changes in reimbursement policies can significantly impact the market dynamics and financial trajectory of Ioflupane I-123.

Challenges and Opportunities

Challenges

• Competition from Generic Versions: The introduction of generic versions can reduce the market share and revenue of the branded product.
• Regulatory Hurdles: Changes in regulatory requirements can affect the approval and distribution of the drug.
• Safety and Efficacy Concerns: Adverse reactions and safety concerns, such as hypersensitivity reactions and thyroid accumulation, need to be carefully managed[4].

Opportunities

• Expanding Market Access: The approval of generic versions can make the diagnostic tool more accessible to a wider range of patients.
• Technological Advancements: Improvements in SPECT technology can enhance the diagnostic accuracy and efficiency of Ioflupane I-123.
• Growing Demand: The increasing prevalence of Parkinsonian syndromes presents a growing market opportunity.

Key Takeaways

• Ioflupane I-123 is a critical diagnostic tool for Parkinsonian syndromes with a growing market demand.
• The approval of a generic version by Curium has introduced competition, potentially reducing costs and increasing accessibility.
• Regulatory approvals and reimbursement policies significantly impact the market dynamics and financial trajectory.
• The market is driven by the increasing prevalence of Parkinsonian syndromes and advancements in diagnostic imaging.

FAQs

What is Ioflupane I-123 used for?

Ioflupane I-123 is used in SPECT brain imaging to help diagnose and differentiate Parkinsonian syndromes from other movement disorders, such as essential tremor[2][5].

Who are the key players in the market for Ioflupane I-123?

The key players include GE Healthcare, the original developer, and Curium, which has introduced a generic version of DaTSCAN[1][4].

How does the generic version of Ioflupane I-123 impact the market?

The generic version introduces competition, potentially reducing costs and making the diagnostic tool more accessible to a wider range of patients[4].

What are the common side effects of Ioflupane I-123?

Common side effects include headache, nausea, vertigo, dry mouth, and dizziness. Hypersensitivity reactions and injection-site pain have also been reported[4].

Is Ioflupane I-123 safe for pregnant women?

Ioflupane I-123 is not recommended for pregnant women due to the potential risk of fetal exposure to radiation. A thyroid blocking agent is recommended if it must be used in pregnant women[4].

Sources

1. Patsnap Synapse: Ioflupane-I-123 - Drug Targets, Indications, Patents.
2. Radiopaedia.org: Ioflupane (I-123).
3. PubChem: Ioflupane I-123.
4. Curium Pharma: Curium Announces FDA Approval of a Generic Version of DaTscan (Ioflupane I 123 Injection) in the U.S.
5. DrugBank: Ioflupane I-123: Uses, Interactions, Mechanism of Action.