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Last Updated: December 22, 2024

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FLUORODOPA F18 Drug Patent Profile


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When do Fluorodopa F18 patents expire, and what generic alternatives are available?

Fluorodopa F18 is a drug marketed by Feinstein and is included in one NDA.

The generic ingredient in FLUORODOPA F18 is fluorodopa f-18. One supplier is listed for this compound. Additional details are available on the fluorodopa f-18 profile page.

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Drug patent expirations by year for FLUORODOPA F18
Recent Clinical Trials for FLUORODOPA F18

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 F18 clinical trials

US Patents and Regulatory Information for FLUORODOPA F18

FLUORODOPA F18 is protected by zero US patents and two FDA Regulatory Exclusivities.

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 F18 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluorodopa F-18

Market Overview

The market for Fluorodopa F-18, a diagnostic agent used in positron emission tomography (PET) scans, is driven by several key factors that influence its growth and financial trajectory.

Increasing Demand for Diagnostic Imaging

The global Fluorodopa F-18 market is propelled by the increasing need for precise diagnostic imaging in healthcare, particularly in the diagnosis of Parkinsonian syndromes and other neurological conditions. The rising prevalence of diseases such as Parkinson's, Alzheimer's, and various types of cancer further amplifies the demand for advanced diagnostic tools like PET scans[1].

Growing Preference for PET/CT Scans

There is a growing preference among individuals and healthcare providers for PET/CT scans due to their high accuracy and detailed imaging capabilities. This trend is especially pronounced in developed countries, where the infrastructure and awareness for such advanced diagnostic techniques are more established[1].

Regional Opportunities

The Asia Pacific region, including countries like India and China, presents significant opportunities for the Fluorodopa F-18 market. The increasing demand for health testing and diagnostic services in these regions is expected to drive market growth[1].

Market Size and Growth

Current Market Valuation

As of 2020, the global Fluorine-18 market, which includes Fluorodopa F-18, was valued at over US$ 1.5 billion. 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].

Segment Dominance

The Fluorodeoxyglucose (FDG) segment, which is closely related to Fluorodopa F-18 in terms of application in PET scans, is expected to dominate the global market. This dominance is attributed to the high demand for PET/CT scans in oncology and other diagnostic applications[1].

End-User Analysis

Hospitals and Diagnostic Centers

Hospitals and diagnostic centers are the primary end-users of Fluorodopa F-18. These institutions are increasingly adopting advanced diagnostic technologies, driving the demand for Fluorodopa F-18. The market attractiveness analysis by end-user indicates a strong preference for hospitals and diagnostic centers due to their high utilization rates of PET scans[1].

Regional Market Analysis

North America and Europe

North America and Europe are significant markets for Fluorodopa F-18, driven by the advanced healthcare infrastructure and high adoption rates of PET/CT scans. These regions are expected to continue their dominance due to ongoing research and development in diagnostic imaging[1].

Asia Pacific

The Asia Pacific region is emerging as a key market due to the rising demand for diagnostic services and the increasing prevalence of diseases that require advanced imaging. Countries like India and China are offering notable opportunities for Fluorodopa F-18 producers[1].

Key Players

The global Fluorodopa F-18 market is characterized by the presence of several key players, including:

  • Lantheus Holdings, Inc.
  • Siemens Healthineers
  • Advanced Accelerator Applications (a Novartis AG Company)
  • GE Healthcare (General Electric Company)
  • Blue Earth Diagnostics (A Bracco Imaging Company)

These companies play a crucial role in the production, distribution, and innovation of Fluorodopa F-18 and other related isotopes[1].

Clinical Applications and Benefits

Parkinsonian Syndromes

Fluorodopa F-18 is specifically indicated for the visual detection of dopaminergic nerve terminals in the striatum, aiding in the diagnosis of Parkinsonian syndromes. It is used adjunctively with other diagnostic investigations to provide more accurate clinical diagnoses[3][4].

Diagnostic Accuracy

Clinical trials have shown that Fluorodopa F-18 PET images have high positive and negative percent agreement with the reference clinical diagnostic standard of Parkinsonian syndromes. This accuracy enhances the reliability of the diagnostic process[4].

Safety and Side Effects

Radiation Exposure

As a radioactive drug, Fluorodopa F-18 may increase the risk of lifetime radiation exposure. However, its short half-life (approximately 1-3 hours) and rapid clearance from the body mitigate some of these risks[3][4].

Financial Projections

Given the projected CAGR of 7.5% from 2021 to 2031, the Fluorodopa F-18 market is expected to see significant financial growth. The increasing demand for PET scans, coupled with the expanding healthcare infrastructure in emerging markets, will drive this growth.

Revenue Forecast

By 2031, the global Fluorine-18 market, which includes Fluorodopa F-18, is expected to exceed US$ 3 billion. This growth will be driven by the increasing adoption of PET/CT scans in various medical specialties and the rising prevalence of diseases requiring advanced diagnostic imaging[1].

Key Takeaways

  • Growing Demand: The market for Fluorodopa F-18 is driven by the increasing need for precise diagnostic imaging.
  • Regional Opportunities: Asia Pacific countries offer significant growth opportunities.
  • Segment Dominance: The FDG segment dominates the market due to high demand in oncology.
  • Clinical Applications: Fluorodopa F-18 is crucial for diagnosing Parkinsonian syndromes.
  • Financial Growth: The market is projected to grow at a CAGR of 7.5% from 2021 to 2031.

FAQs

What is Fluorodopa F-18 used for?

Fluorodopa F-18 is used with positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes[3][4].

What are the benefits of using Fluorodopa F-18 in clinical diagnosis?

Fluorodopa F-18 enhances the accuracy of clinical diagnoses of Parkinsonian syndromes by providing clear images of dopaminergic nerve terminals. It has high positive and negative percent agreement with the reference clinical diagnostic standard[4].

What are the potential side effects of Fluorodopa F-18?

As a radioactive drug, Fluorodopa F-18 may increase the risk of lifetime radiation exposure. However, its short half-life and rapid clearance from the body minimize these risks[3][4].

Which regions are expected to drive the growth of the Fluorodopa F-18 market?

The Asia Pacific region, particularly countries like India and China, is expected to drive significant growth due to the rising demand for diagnostic services and advanced healthcare infrastructure[1].

What is the projected market size of the Fluorine-18 market by 2031?

The global Fluorine-18 market, which includes Fluorodopa F-18, is projected to exceed US$ 3 billion by 2031, growing at a CAGR of 7.5% from 2021 to 2031[1].

Sources

  1. Transparency Market Research: Fluorine-18 Market Insight and Trends 2031.
  2. University of Wisconsin-Madison: Rate of 6[18F]fluorodopa uptake decline in striatal subregions in Parkinson’s disease.
  3. DrugBank: Fluorodopa (18F): Uses, Interactions, Mechanism of Action.
  4. FDA: Drug Trials Snapshots: FLUORODOPA F 18.
  5. ScienceDirect: Can 18F-FDOPA PET/CT predict survival in patients with suspected recurrent glioma.

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