You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

FLUORINE F-18 Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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. Ten 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.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for FLUORINE F-18?
  • What are the global sales for FLUORINE F-18?
  • What is Average Wholesale Price for FLUORINE F-18?
Summary for FLUORINE F-18
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 116
Clinical Trials: 92
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
Andrei IagaruPhase 2/Phase 3
AHS Cancer Control AlbertaPhase 2
Istituto Scientifico Romagnolo per lo Studio e la cura dei TumoriPhase 2

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 ⤷  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

FLUORINE F-18 Market Analysis and Financial Projection Experimental

Fluorine-18 Market Dynamics and Financial Trajectory

Introduction to Fluorine-18

Fluorine-18 (F-18) is a radionuclide that plays a crucial role in positron emission tomography (PET) and other medical imaging techniques. Its unique physical and nuclear characteristics make it an essential component in the diagnosis and treatment of various diseases, particularly cancer, cardiovascular diseases, and neurological disorders.

Market Size and Growth

The global fluorine-18 market was valued at over US$ 1.5 billion in 2020 and is projected to expand significantly over the next decade. It is expected to reach approximately US$ 3 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 7.4% to 7.5% from 2021 to 2031[1][4][5].

Key Drivers of Market Growth

Increasing Demand for PET/CT Scans

The rising preference for PET/CT and PET scans is a major driver of the fluorine-18 market. These modern imaging systems are used to detect and treat cancer, cardiovascular diseases, and other neurological disorders. The accuracy and precision of PET/CT scans, especially in oncology, have increased their demand globally[4][5].

Growing Prevalence of Diseases

The global increase in the frequency and prevalence of diseases such as cancer, Alzheimer’s, and cardiovascular diseases is generating a higher demand for precise diagnostic tools. Fluorine-18, particularly through its use in FDG (2-[fluorine 18] fluoro-2-deoxy-D-glucose), is at the forefront of this diagnostic revolution[1][4].

Expanding Clinical Applications

Beyond oncology, FDG PET-CT is increasingly used in cardiology, neurology, and cognitive neuroscience. This broader application spectrum further boosts the demand for fluorine-18[5].

Market Segmentation

By Product

The global fluorine-18 market is segmented into FDG, NaF (sodium fluoride), and others. The FDG segment is expected to dominate the market by 2031 due to its widespread use in PET/CT scans for oncology[1][4][5].

By End User

The market is divided into hospitals, diagnostic centers, and others. Hospitals are anticipated to be the major end users, driven by the increasing demand for new PET-CT machines in upcoming hospital projects worldwide[1][4][5].

Regional Analysis

North America

North America dominated the global fluorine-18 market in 2020, followed by Europe. The high demand for cancer scan procedures and the presence of advanced healthcare infrastructure in this region contribute to its leading position[1][4][5].

Asia Pacific

The Asia Pacific region is projected to expand at a high CAGR from 2021 to 2031. Countries like China and India offer significant opportunities due to the rising demand for health testing purposes and the expansion of local players through product launches, acquisitions, and distribution agreements[1][4][5].

Competitive Landscape

The global fluorine-18 market is competitive, with key players focusing on strengthening their distribution networks and expanding their product ranges. Leading companies include:

  • Lantheus Holdings, Inc.
  • Siemens Healthineers
  • Advanced Accelerator Applications (a Novartis AG Company)
  • GE Healthcare (General Electric Company)
  • Blue Earth Diagnostics (A Bracco Imaging Company)
  • Jubilant Pharma Limited
  • China Isotope & Radiation Corporation
  • Eli Lilly and Company
  • Curium Pharma
  • Yantai Dongcheng Pharmaceutical Group Co., Ltd.[1][4][5]

These companies engage in strategic activities such as product launches, acquisitions, and partnerships to enhance their market share.

Challenges and Limitations

Lack of Availability and High Operating Expenses

Despite the growth potential, the fluorine-18 market faces challenges such as the lack of availability of FDG-PET and the high operating expenses associated with establishing PET/CT scan facilities. The cost of setting up a PET/CT scan facility with a cyclotron can range from US$ 5 million to US$ 6 million[4].

Production and Use of Fluorine-18

Fluorine-18 is produced in cyclotrons through the interaction of helium-3 beams with oxygen, resulting in the formation of radioactive fluorine-18. This isotope decays by positron emission, producing stable oxygen-18, which is detected by PET cameras[2].

Future Outlook

The future of the fluorine-18 market looks promising, driven by the increasing demand for precise diagnostic tools and the expanding clinical applications of PET/CT scans. As healthcare technologies continue to advance and the prevalence of diseases requiring PET imaging increases, the demand for fluorine-18 is expected to rise significantly.

Key Takeaways

  • Market Growth: The global fluorine-18 market is projected to reach US$ 3 billion by 2030, growing at a CAGR of 7.4% to 7.5% from 2021 to 2031.
  • Dominant Segment: The FDG segment is expected to dominate the market due to its high demand in oncology.
  • Regional Leadership: North America currently leads the market, with the Asia Pacific region expected to grow at a high CAGR.
  • Challenges: High operating expenses and the lack of availability of FDG-PET are significant challenges.
  • Key Players: Major companies include Lantheus Holdings, Inc., Siemens Healthineers, and Advanced Accelerator Applications.

FAQs

Q: What is the primary use of fluorine-18 in medical imaging? A: Fluorine-18 is primarily used in positron emission tomography (PET) scans, particularly through the tracer FDG, for diagnosing and treating various diseases including cancer.

Q: Which region is expected to grow at the highest CAGR in the fluorine-18 market? A: The Asia Pacific region is projected to expand at a high CAGR from 2021 to 2031 due to rising demand and expansion of local players.

Q: What are the main challenges facing the fluorine-18 market? A: The main challenges include the lack of availability of FDG-PET and the high operating expenses associated with establishing PET/CT scan facilities.

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

Q: How is fluorine-18 produced? A: Fluorine-18 is produced in cyclotrons through the interaction of helium-3 beams with oxygen, resulting in the formation of radioactive fluorine-18[2].

Sources

  1. Transparency Market Research - Fluorine-18 Market Insight and Trends 2031
  2. University of Birmingham - Radioactively Labelled Tracers
  3. ACS Publications - Next Generation of Fluorine-Containing Pharmaceuticals
  4. BioSpace - Growing Use of Fluorine-18 for PET Imaging Drives Global Demand
  5. BioSpace - Fluorine-18 Market Size Worth Around US$ 3 Billion by 2030

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.