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Last Updated: December 21, 2024

Fluorodopa f-18 - Generic Drug Details


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What are the generic sources for fluorodopa f-18 and what is the scope of patent protection?

Fluorodopa f-18 is the generic ingredient in one branded drug marketed by Feinstein and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for fluorodopa f-18
Recent Clinical Trials for fluorodopa f-18

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

SponsorPhase
Andrew NewbergPhase 2
Thomas Jefferson UniversityPhase 2
Washington University School of MedicinePhase 1

See all fluorodopa f-18 clinical trials

US Patents and Regulatory Information for fluorodopa f-18

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Feinstein FLUORODOPA F18 fluorodopa f-18 SOLUTION;INTRAVENOUS 200655-001 Oct 10, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Fluorodopa f-18 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluorodopa F-18

Introduction to Fluorodopa F-18

Fluorodopa F-18, also known as 18F-FDOPA, is a diagnostic radiopharmaceutical used in Positron Emission Tomography (PET) to visualize dopaminergic neurons in the brain. It is particularly useful in the evaluation of patients with suspected Parkinsonian syndromes (PS)[2][4].

Market Definition and Scope

The market for Fluorodopa F-18 is part of the broader fluorine-18 (F-18) market, which includes various F-18 based radiopharmaceuticals. The F-18 market is driven by the increasing need for precise diagnostic tools in healthcare, especially in the fields of oncology, neurology, and cardiology[1].

Key Drivers of the Market

Increasing Prevalence of Diseases

The global rise in diseases such as cancer, Alzheimer’s, and cardiovascular diseases is a significant driver for the F-18 market. Fluorodopa F-18, being a critical tool in diagnosing Parkinsonian syndromes, benefits from this trend[1].

Advancements in PET Imaging

The growing preference for PET/CT scans due to their high diagnostic accuracy is another key factor. PET imaging, enhanced by radiopharmaceuticals like Fluorodopa F-18, is becoming more prevalent, especially in developed countries[1].

Regulatory Approvals

Fluorodopa F-18 has received approvals in several countries, including France and other European Union nations. Its approval in the US, based on extensive clinical studies, further solidifies its market position[2].

Market Segmentation

By Product

The F-18 market is segmented into various products, with Fluorodeoxyglucose (FDG) being the dominant segment. However, Fluorodopa F-18 is a significant player in the neurology segment, particularly for diagnosing Parkinsonian syndromes[1].

By End-User

The market is segmented by end-users such as hospitals, diagnostic centers, and others. Hospitals and diagnostic centers are the primary users of Fluorodopa F-18 due to the specialized equipment and expertise required for PET scans[1].

By Region

The Asia Pacific region, including countries like India and China, offers substantial growth opportunities due to increasing healthcare demands and rising health awareness[1].

Financial Trajectory

Current Market Value

The global fluorine-18 market, which includes Fluorodopa F-18, was valued at over US$ 1.5 billion in 2020. This market is projected to expand at a Compound Annual Growth Rate (CAGR) of 7.5% from 2021 to 2031, reaching a valuation of over US$ 3 billion by 2031[1].

Revenue Growth

The revenue growth of Fluorodopa F-18 is closely tied to the overall growth of the F-18 market. As the demand for PET imaging increases, especially in neurology, the revenue from Fluorodopa F-18 is expected to rise significantly.

Key Players

Major players in the F-18 market, including Lantheus Holdings, Inc., Siemens Healthineers, Advanced Accelerator Applications (a Novartis AG Company), GE Healthcare, and Blue Earth Diagnostics, play a crucial role in the production and distribution of Fluorodopa F-18. These companies invest heavily in research and development, which drives market growth[1].

Regional Analysis

North America and Europe

These regions are currently the largest markets for Fluorodopa F-18 due to advanced healthcare infrastructure and high demand for PET scans. The market in these regions is expected to continue growing, driven by the increasing prevalence of neurodegenerative diseases[1].

Asia Pacific

The Asia Pacific region is emerging as a significant market due to the rising demand for healthcare services and the growing awareness of advanced diagnostic techniques. Countries like India and China are expected to drive the growth of the F-18 market, including Fluorodopa F-18, in the coming years[1].

Challenges and Opportunities

Regulatory Hurdles

While regulatory approvals are a significant driver, navigating the complex regulatory landscape can be challenging. Continuous compliance with regulatory requirements is essential for market growth[2].

Technological Advancements

Advancements in PET imaging technology and the development of new radiopharmaceuticals present opportunities for growth. Innovations that improve the diagnostic accuracy and safety of Fluorodopa F-18 can further enhance its market position[5].

Safety and Efficacy

Clinical Evidence

The safety and efficacy of Fluorodopa F-18 are supported by extensive clinical studies. For instance, the FDA approval was based on studies that demonstrated its effectiveness in visualizing dopaminergic neurons in patients with suspected Parkinsonian syndromes[2].

Radiation Safety

The radiation exposure from Fluorodopa F-18 PET scans is comparable to other commonly used diagnostic radiopharmaceuticals, ensuring patient safety[2].

Conclusion

The market for Fluorodopa F-18 is poised for significant growth, driven by the increasing demand for precise diagnostic tools in healthcare. With a projected CAGR of 7.5% and a valuation expected to exceed US$ 3 billion by 2031, the financial trajectory of Fluorodopa F-18 looks promising.

Key Takeaways

  • Growing Demand: Increasing prevalence of diseases like Parkinson’s and the growing preference for PET scans drive the market.
  • Regulatory Approvals: Approvals in multiple countries, including the US and EU, support market growth.
  • Regional Growth: Asia Pacific region offers significant growth opportunities.
  • Safety and Efficacy: Supported by extensive clinical evidence and comparable radiation safety.
  • Market Value: Projected to exceed US$ 3 billion by 2031.

Frequently Asked Questions (FAQs)

Q: What is Fluorodopa F-18 used for? A: Fluorodopa F-18 is used in PET scans to visualize dopaminergic neurons in the brain, particularly for diagnosing Parkinsonian syndromes.

Q: What is the current market value of the fluorine-18 market? A: The global fluorine-18 market was valued over US$ 1.5 billion in 2020.

Q: What is the projected growth rate of the fluorine-18 market? A: The market is projected to expand at a CAGR of 7.5% from 2021 to 2031.

Q: Which regions are driving the growth of the Fluorodopa F-18 market? A: North America, Europe, and the Asia Pacific region are driving the growth, with the Asia Pacific region offering significant opportunities.

Q: Who are the key players in the F-18 market? A: Key players include Lantheus Holdings, Inc., Siemens Healthineers, Advanced Accelerator Applications, GE Healthcare, and Blue Earth Diagnostics.

Cited Sources

  1. Transparency Market Research: Fluorine-18 Market Insight and Trends 2031.
  2. FDA: Multi-Discipline Review - Fluorodopa F 18 Injection.
  3. Wiley Online Library: Longitudinal Meta‐Analysis of Historical Parkinson's Disease Trials.
  4. Synapse: FLUORODOPA F-18 - Drug Targets, Indications, Patents.
  5. Wiley Online Library: Exploring the mechanism of 18F‐fluorodopa uptake in recurrent gliomas.

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