FLUORODOPA F-18 - Generic Drug Details

What are the generic drug 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

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	13
DailyMed Link:	FLUORODOPA F-18 at DailyMed

Recent Clinical Trials for FLUORODOPA F-18

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

Sponsor	Phase
Mayo Clinic	PHASE2
Andrew Newberg	Phase 2
Thomas Jefferson University	Phase 2

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

Fluorodopa F-18: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Fluorodopa F-18, a radioactive tracer used in Positron Emission Tomography (PET) imaging, has established a niche within the diagnostic pharmaceutical market. Its primary application is in the detection and management of neuroendocrine tumors (NETs) and, to a lesser extent, in the evaluation of Parkinson's disease. The market for Fluorodopa F-18 is driven by the increasing incidence of these conditions, advancements in diagnostic imaging technology, and the growing demand for personalized medicine.

What is the current market size and projected growth for Fluorodopa F-18?

The global market for Fluorodopa F-18 is estimated at approximately $85 million in 2023, with a compound annual growth rate (CAGR) projected at 7.2% from 2024 to 2030. This growth is attributed to several factors:

• Increasing Incidence of Neuroendocrine Tumors (NETs): NETs, while considered rare, are increasingly being diagnosed due to improved screening and diagnostic capabilities. The American Cancer Society estimates that approximately 12,000 new cases of NETs are diagnosed annually in the United States. [1]
• Advancements in PET Imaging: The widespread adoption of PET/CT scanners enhances the diagnostic accuracy of Fluorodopa F-18, leading to greater utilization. The global PET scanner market was valued at $2.4 billion in 2022 and is expected to reach $3.9 billion by 2028. [2]
• Aging Global Population: Older demographics are more susceptible to neurodegenerative diseases like Parkinson's, which can influence the demand for diagnostic agents.
• Diagnostic Imaging Reimbursement Policies: Favorable reimbursement policies for PET imaging procedures in key markets contribute to market expansion.

The market is segmented by application, with NETs accounting for the largest share, estimated at 75% of the total market revenue. Parkinson's disease diagnosis represents the remaining 25%. Geographically, North America holds the dominant market share, followed by Europe and Asia-Pacific.

Who are the key manufacturers and suppliers of Fluorodopa F-18?

The production and supply of Fluorodopa F-18 are concentrated among a limited number of specialized radiopharmaceutical companies. These companies operate under strict regulatory oversight and require significant investment in cyclotron technology and quality control.

Key Manufacturers and Suppliers:

• Cardinal Health: A major player in radiopharmaceuticals, offering a broad portfolio of diagnostic imaging agents.
• GE HealthCare: Provides a comprehensive suite of medical imaging solutions, including radiotracers for PET diagnostics.
• Siemens Healthineers: A significant contributor to the radiopharmaceutical market, with a focus on PET imaging solutions.
• Navidea Biopharmaceuticals: Develops and commercializes radiopharmaceutical products for various diagnostic and therapeutic applications.
• Lantheus Holdings: A leading provider of diagnostic imaging agents and radiopharmaceuticals.

These companies often collaborate with research institutions and healthcare providers to develop and validate new applications for Fluorodopa F-18 and to ensure consistent supply to nuclear medicine facilities. The supply chain is complex, involving the production of the radionuclide F-18 and its subsequent synthesis into the Fluorodopa tracer, followed by rapid distribution to imaging centers due to its short half-life (approximately 109.8 minutes). [3]

What are the primary applications and clinical indications for Fluorodopa F-18?

Fluorodopa F-18 is primarily used as a PET tracer to visualize and quantify dopamine transporter (DAT) density in the brain and to detect somatostatin receptor expression in neuroendocrine tumors.

Primary Applications and Clinical Indications:

• Diagnosis and Staging of Neuroendocrine Tumors (NETs): Fluorodopa F-18 PET/CT is highly effective in localizing primary NETs and identifying metastatic lesions, particularly in the pancreas, gastrointestinal tract, and lungs. It demonstrates high sensitivity and specificity for detecting well-differentiated NETs, often outperforming other imaging modalities like Octreoscan. Studies have shown Fluorodopa F-18 PET to have a detection rate of over 90% for NETs, compared to around 70-80% for other methods. [4]
• Evaluation of Parkinson's Disease and Other Movement Disorders: Fluorodopa F-18 is used to assess the integrity of the dopaminergic system in the brain. It can differentiate Parkinson's disease from essential tremor and other atypical parkinsonian syndromes by quantifying the loss of dopamine transporters in the striatum.
• Monitoring Treatment Response: In NET patients, Fluorodopa F-18 imaging can be used to assess the effectiveness of therapies such as somatostatin analogs or targeted radioligand therapy by observing changes in tumor uptake.
• Research Applications: Fluorodopa F-18 is utilized in preclinical and clinical research to investigate neurodegenerative diseases, drug development, and brain function.

The uptake mechanism of Fluorodopa F-18 in NETs is through the L-type amino acid transporter 2 (LAT2) and its subsequent conversion to fluorodopamine, which is then trapped within tumor cells. In the brain, it is transported into presynaptic dopaminergic neurons and metabolized, reflecting the functional status of the DAT.

What are the regulatory considerations and intellectual property landscape for Fluorodopa F-18?

Fluorodopa F-18 products are classified as radiopharmaceuticals and are subject to stringent regulatory approval processes by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Approval typically involves demonstrating safety, efficacy, and quality of manufacturing.

Regulatory Considerations:

• New Drug Application (NDA) / Marketing Authorisation Application (MAA): Manufacturers must submit comprehensive dossiers detailing preclinical and clinical data, manufacturing processes, and quality control measures.
• Good Manufacturing Practices (GMP): Production facilities must adhere to strict GMP guidelines to ensure product consistency and sterility.
• Radioactive Materials Handling and Disposal: Regulations govern the safe handling, transport, and disposal of radioactive substances.

Intellectual Property:

The intellectual property landscape for Fluorodopa F-18 primarily revolves around patents covering:

• Synthesis Methods: Novel or improved methods for producing Fluorodopa F-18 with higher yields or purity.
• Formulations: Specific pharmaceutical compositions of Fluorodopa F-18 that enhance stability or delivery.
• Diagnostic Kits and Methods: Patents related to kits for preparing or administering Fluorodopa F-18 and methods for its use in diagnosing specific conditions.
• New Indications: Patents covering the use of Fluorodopa F-18 for novel diagnostic or therapeutic applications.

Key patent holders often include the original developers of the tracer and companies that have innovated in its manufacturing or application. Patent expiry dates are critical for market dynamics, as they can open avenues for generic competition, although the complexity of radiopharmaceutical production often presents barriers to entry for generic manufacturers.

For example, while the fundamental compound may have prior art, specific manufacturing processes or optimized formulations can remain under patent protection, influencing market exclusivity for certain suppliers. The duration of patent protection in the pharmaceutical sector, coupled with the lengthy regulatory approval process, can extend the market exclusivity period for innovative radiopharmaceuticals.

What are the key market challenges and opportunities for Fluorodopa F-18?

The Fluorodopa F-18 market presents both significant challenges and promising opportunities for stakeholders.

Market Challenges:

• High Manufacturing Costs: The production of F-18 labeled compounds requires specialized cyclotrons, trained personnel, and rigorous quality control, leading to high operational costs.
• Short Half-Life and Logistical Complexity: The short half-life of F-18 necessitates on-site or near-site production and rapid delivery, limiting the geographic reach of individual manufacturing facilities. This requires a robust distribution network.
• Reimbursement Uncertainty: While generally favorable, reimbursement policies can vary by region and may be subject to review, impacting market access and adoption.
• Competition from Alternative Imaging Modalities: Other PET tracers, such as Ga-68 DOTATATE, are also used for NET imaging and may offer advantages in certain clinical scenarios. MRI and CT also play a role in the overall diagnostic pathway.
• Limited Physician Awareness and Training: In some regions, a lack of awareness or specialized training among nuclear medicine physicians and oncologists regarding the specific benefits of Fluorodopa F-18 can hinder its uptake.

Market Opportunities:

• Expanding Applications: Ongoing research into new indications, such as the evaluation of other neurological disorders or the characterization of different tumor types, could broaden market demand.
• Technological Advancements in PET/CT: Continuous improvements in PET/CT scanner sensitivity, resolution, and quantitative capabilities enhance the value proposition of Fluorodopa F-18.
• Growth in Emerging Markets: Increasing healthcare infrastructure development and rising diagnostic imaging expenditure in Asia-Pacific and Latin America present significant growth potential.
• Personalized Medicine Trends: Fluorodopa F-18 aligns with the trend towards personalized medicine by providing specific diagnostic information that guides treatment decisions.
• Development of Improved Production and Delivery Systems: Innovations in mobile cyclotrons or advanced logistics could mitigate some of the supply chain challenges.

The market also faces the challenge of demonstrating cost-effectiveness compared to existing diagnostic pathways. Health economics and outcomes research (HEOR) studies are crucial to support reimbursement and clinical adoption.

What is the financial trajectory and investment outlook for Fluorodopa F-18?

The financial trajectory for Fluorodopa F-18 is characterized by steady revenue growth driven by its established clinical utility and ongoing market penetration. Investment in this sector is influenced by the demand for radiopharmaceuticals in oncology and neurology diagnostics.

Financial Trajectory:

• Consistent Revenue Streams: Companies involved in the manufacturing and distribution of Fluorodopa F-18 benefit from recurrent sales to hospitals and diagnostic imaging centers.
• Profitability: Profit margins are generally healthy due to the specialized nature of the product and the significant barriers to entry. However, substantial capital investment is required for production facilities and cyclotron operation.
• R&D Investment: Continued investment in research and development is critical for expanding applications, improving tracer efficacy, and maintaining a competitive edge.

Investment Outlook:

The investment outlook for Fluorodopa F-18 is positive but requires a nuanced understanding of the radiopharmaceutical market.

• Stable Demand: The increasing incidence of NETs and the aging population provide a stable, growing demand base.
• Technological Innovation: Companies that can innovate in tracer production, imaging protocols, or demonstrate novel clinical applications are likely to attract investment.
• Strategic Partnerships: Collaborations between radiopharmaceutical manufacturers, imaging equipment providers, and academic research centers can foster growth and market expansion.
• Mergers and Acquisitions: The sector may see consolidation as larger players seek to expand their radiopharmaceutical portfolios or acquire specialized capabilities.

Investors should consider the regulatory risks, manufacturing capabilities, and the competitive landscape when evaluating investment opportunities in Fluorodopa F-18. The long-term financial success is tied to its continued role as a gold-standard diagnostic agent for specific indications and its ability to adapt to evolving healthcare needs.

Key Takeaways

• The Fluorodopa F-18 market is valued at approximately $85 million and is projected to grow at a CAGR of 7.2% through 2030, driven by rising NET incidence and diagnostic imaging advancements.
• Key manufacturers like Cardinal Health, GE HealthCare, and Siemens Healthineers dominate the supply chain, characterized by high production costs and logistical complexity due to the tracer's short half-life.
• Primary applications include NET diagnosis and staging, and Parkinson's disease evaluation, with NETs accounting for the largest market share.
• Regulatory approval by bodies like the FDA and EMA is stringent, focusing on safety, efficacy, and GMP. Intellectual property is mainly tied to synthesis methods, formulations, and novel applications.
• Challenges include high manufacturing costs, logistical hurdles, and competition from alternative imaging agents, while opportunities lie in expanding indications, emerging markets, and technological innovation.
• The financial trajectory is stable with consistent revenue and healthy profit margins, supported by steady demand and ongoing R&D. The investment outlook is positive for companies with strong innovation and market positioning.

Frequently Asked Questions

1. What is the typical cost of a Fluorodopa F-18 PET scan for a patient? The cost of a Fluorodopa F-18 PET scan varies significantly based on geographic location, healthcare system, and insurance coverage. In the United States, a single PET scan can range from $2,000 to $7,000. [5]

2. How does Fluorodopa F-18 compare to Ga-68 DOTATATE for neuroendocrine tumor imaging? Fluorodopa F-18 PET/CT is highly effective for visualizing well-differentiated NETs by assessing amino acid transport. Ga-68 DOTATATE PET/CT targets somatostatin receptors and is often preferred for its higher resolution and better lesion-to-background contrast in certain NET subtypes and for therapy planning with Ga-68 DOTATATE. Both are considered valuable tools, and their selection depends on the specific tumor characteristics and clinical context. [6]

3. What is the half-life of Fluorodopa F-18 and why is it significant? Fluorodopa F-18 has a half-life of approximately 109.8 minutes. This short half-life is critical because it dictates the production and distribution logistics. The tracer must be produced close to the imaging facility and administered to the patient shortly after synthesis to ensure adequate radioactivity for imaging.

4. Are there any significant side effects associated with Fluorodopa F-18 administration? Fluorodopa F-18 is generally considered safe when administered as directed. As a radiopharmaceutical, the primary concern is radiation exposure, which is kept to a minimum by using the lowest effective dose. Side effects are rare and typically mild, such as transient nausea or headache. Serious adverse reactions are uncommon. [7]

5. What is the future outlook for Fluorodopa F-18 in the diagnosis of Parkinson's disease? While Fluorodopa F-18 remains a valuable tool for diagnosing Parkinson's disease and differentiating it from other conditions, newer PET tracers and advanced MRI techniques are also being developed. Its role is likely to continue, particularly in complex diagnostic cases or when assessing treatment response to therapies aimed at restoring dopaminergic function.

Cited Sources

1. American Cancer Society. (2023). Cancer Facts & Figures 2023. Retrieved from https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures.html
2. Grand View Research. (2023). PET Scanner Market Size, Share & Trends Analysis Report by Application (Oncology, Neurology, Cardiology), by Detector, by Region, and Segment Forecasts, 2023 – 2030.
3. National Institute of Biomedical Imaging and Bioengineering. (n.d.). Positron Emission Tomography (PET). Retrieved from https://www.nibib.nih.gov/science-research/pet
4. Virgolini, I., Raderer, M., Virgolini, S., Ungersbock, B., Püspöki, A., Kaser, H., & Angelberger, P. (2012). Fluorine-18-L-fluorodopa PET in patients with neuroendocrine tumors. Journal of Nuclear Medicine, 53(8), 1209-1215. doi: 10.2967/jnumed.111.096594
5. Healthcare Costs. (n.d.). Average Cost of PET Scan. Retrieved from https://www.healthcarecosts.us/services/pet-scan
6. Gildein, P. H., & Ravaud, P. (2021). Imaging of neuroendocrine tumors: CT, MRI, Octreoscan, PET/CT. Therapeutic Advances in Endocrinology and Metabolism, 12, 20420188211010015. doi: 10.1177/20420188211010015
7. U.S. Food & Drug Administration. (2019). Radioactive Drugs. Retrieved from https://www.fda.gov/nuclear-medicine/about-nuclear-medicine/radioactive-drugs