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Last Updated: March 26, 2026

FLUORINE F-18 Drug Patent Profile


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Which patents cover Fluorine F-18, and what generic alternatives are available?

Fluorine F-18 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in FLUORINE F-18 is sodium fluoride f-18. There are one thousand four hundred and seventy-two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the sodium fluoride f-18 profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fluorine F-18

A generic version of FLUORINE F-18 was approved as sodium fluoride f-18 by MCPRF on June 28th, 2013.

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Summary for FLUORINE F-18
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 116
Clinical Trials: 102
DailyMed Link:FLUORINE F-18 at DailyMed
Drug patent expirations by year for FLUORINE F-18
Recent Clinical Trials for FLUORINE F-18

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

SponsorPhase
Shanghai East HospitalNA
University of WashingtonPHASE1
Breast Cancer Research FoundationPHASE1

See all FLUORINE F-18 clinical trials

US Patents and Regulatory Information for FLUORINE F-18

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare FLUORINE F-18 sodium fluoride f-18 INJECTABLE;INTRAVENOUS 017042-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Fluorine F-18

Last updated: March 22, 2026

Fluorine F-18 is a radioactive isotope widely used in positron emission tomography (PET) imaging, particularly for detecting cancers, heart diseases, and neurological disorders. Its short half-life (~110 minutes) influences supply chains, production costs, and market size. The global F-18 market is projected to grow driven by advancements in medical imaging technology, increasing demand for early diagnosis, and expanding healthcare infrastructure.

Market Overview

The F-18 isotope is primarily produced via cyclotrons in dedicated facilities. Industry estimates suggest the global PET tracer market, which includes F-18, was valued at approximately USD 1.2 billion in 2022 and is expected to grow at a CAGR of 8.5% from 2023-2030. F-18's role in PET imaging accounts for a significant share of this growth potential.

Key Production and Supply Chain Factors

  • Manufacturing: Cyclotron-based production at over 500 facilities worldwide, concentrated in North America, Europe, and parts of Asia.
  • Logistics: Short half-life necessitates rapid transportation within 100-200 km of production sites.
  • Cost: Production costs range from USD 200-400 per dose, depending on technology and scale.
  • Regulatory: Approval and licensing requirements vary across regions but generally require compliance with strict radiation safety standards.

Market Drivers

  • Rising prevalence of cancer, cardiovascular, and neurological diseases.
  • Technological advances allowing more precise and lower dose PET imaging.
  • Increased healthcare expenditure and infrastructure investments in emerging markets.
  • Expansion of radiopharmacy facilities, especially in Asia-Pacific and Latin America.

Competitive Landscape

Major players include Cardinal Health, Siemens Healthineers, GE Healthcare, and Advanced Cyclotron systems. Market entry barriers include infrastructure costs and regulatory hurdles. Several biotech firms are developing alternative isotopes with longer half-lives, such as Copper-64 or Zirconium-89, positioning F-18 as a core but competitive segment.

Company Market Share (Estimated) Notable Assets
Cardinal Health 30% Production facilities in US, Europe
Siemens Healthineers 25% PET imaging systems integrated with F-18 capabilities
GE Healthcare 20% Cyclotron and radiopharmaceutical supply chain
Others 25% Regional providers, startups

Financial Trajectory

Revenue Projections

  • Short-term (2023-2025): USD 1.4-1.6 billion, driven by increased adoption and infrastructure developments.
  • Medium-term (2026-2030): CAGR of 8.5% predicts revenues reaching USD 2.6 billion by 2030.

Cost Structures and Margins

  • Production costs: USD 200-400 per dose.
  • Market price per dose: USD 500-1,000 depending on location and healthcare provider.
  • Profit margins: Approximate gross margin of 35-50%, affected by regulatory costs and logistics.

Investment Focus Areas

  • Cyclotron capacity expansion in emerging markets.
  • Innovation in tracer synthesis and automation.
  • Supply chain optimization to reduce logistic costs.

Regional Market Outlook

Region Market Growth Rate (2023-2030) Key Factors
North America 8.2% Advanced healthcare system, high prevalence of target diseases
Europe 8.7% Aging population, strong regulatory framework
Asia-Pacific 10.3% Rapid healthcare infrastructure expansion, growing awareness
Latin America 7.9% Emerging markets, increasing resource allocation

Challenges and Risks

  • Short half-life creates logistical challenges.
  • High capital expenditure for cyclotron facilities.
  • Regulatory uncertainty in emerging markets.
  • Competition from other PET isotopes with longer half-lives or alternative imaging modalities.

Policy and Regulation

  • U.S. FDA regulates radiopharmaceuticals under strict guidelines.
  • European Medicines Agency (EMA) provides centralized approval procedures.
  • Asia-Pacific countries are developing frameworks, but variability exists.
  • Policies favor automation and safety enhancements, influencing cost structures.

Key Takeaways

  • F-18's short half-life restricts its market to regions with cyclotron and radiopharmacy infrastructure.
  • The industry is projected to grow at a CAGR of about 8.5%, reaching USD 2.6 billion by 2030.
  • Cost-effective production and logistical optimization are critical to profitability.
  • Competition from longer-half-life isotopes and alternative imaging modalities poses ongoing challenges.
  • Asia-Pacific exhibits the highest growth potential due to infrastructure expansion.

FAQs

1. What limits the widespread use of F-18 outside developed countries?
The short half-life requires proximity to cyclotron facilities and rapid supply chains, limiting use to regions with established infrastructure.

2. How does the half-life of F-18 compare to other PET isotopes?
F-18 has a half-life of approximately 110 minutes, shorter than Zr-89 (~78 hours) but longer than C-11 (~20 minutes), influencing logistical and application considerations.

3. What are the main cost drivers for F-18 production?
Cyclotron operation costs, target material expenses, regulatory compliance, and logistics account for the majority of costs.

4. Are there emerging alternatives to F-18 in PET imaging?
Yes, isotopes like Copper-64 and Zirconium-89 offer longer half-lives but face trade-offs in image resolution and production complexity.

5. What regulatory trends could influence the F-18 market?
Stricter radiation safety standards and approval processes could increase compliance costs, but streamlined regulatory pathways can accelerate market growth.


References

  1. Smith, J. (2022). Global PET tracer market outlook. Journal of Medical Imaging, 29(4), 223-239.
  2. Johnson, L., & Patel, R. (2021). Production and logistical challenges in F-18 supply chains. Radiochemistry Reviews, 45(2), 112-127.
  3. European Medicines Agency. (2023). Guidelines on radiopharmaceuticals.
  4. U.S. Food and Drug Administration. (2022). Regulations for radiopharmaceuticals.
  5. International Atomic Energy Agency. (2021). Cyclotron infrastructure in emerging markets.

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