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Last Updated: January 2, 2025

FLUDEOXYGLUCOSE F18 Drug Patent Profile


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When do Fludeoxyglucose F18 patents expire, and when can generic versions of Fludeoxyglucose F18 launch?

Fludeoxyglucose F18 is a drug marketed by Downstate Clincl, 3d Imaging Drug, Biomedcl Res Fdn, Brigham Womens, Cardinal Health 414, Childrens Hosp Mi, Decatur, Essential Isotopes, Feinstein, Hot Shots Nm Llc, Isologic Innovative, Jubilant Draximage, Kettering Medctr, Kreitchman Pet Ctr, Ma General Hosp, Mcprf, Mem Sloan-kettering, Methodist Hosp Res, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Northland, Nukemed, Petnet, Pharmalogic, Pharmalogic Hldgs, Precision Nuclear, Queen Hamamatsu Pet, Sofie, Trustees Univ Pa, Ucla Biomedical, Ucsf Rodiopharm, Uihc Pet Imaging, Univ Michigan, Univ Southern Ca, Univ Tx Md Anderson, Univ Tx Sw Medctr, Univ Utah Cyclotron, Weill Medcl Coll, Wisconsin, and Wusm Cyclotron. and is included in forty-three NDAs.

The generic ingredient in FLUDEOXYGLUCOSE F18 is fludeoxyglucose f-18. There are eight drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fludeoxyglucose f-18 profile page.

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Summary for FLUDEOXYGLUCOSE F18
US Patents:0
Applicants:41
NDAs:43
Finished Product Suppliers / Packagers: 22
Raw Ingredient (Bulk) Api Vendors: 19
Clinical Trials: 183
Patent Applications: 736
What excipients (inactive ingredients) are in FLUDEOXYGLUCOSE F18?FLUDEOXYGLUCOSE F18 excipients list
DailyMed Link:FLUDEOXYGLUCOSE F18 at DailyMed
Drug patent expirations by year for FLUDEOXYGLUCOSE F18
Recent Clinical Trials for FLUDEOXYGLUCOSE F18

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

SponsorPhase
Robert Flavell, MD, PhDPhase 1
Michael TopfPhase 1
Xencor, Inc.Phase 1

See all FLUDEOXYGLUCOSE F18 clinical trials

Pharmacology for FLUDEOXYGLUCOSE F18

US Patents and Regulatory Information for FLUDEOXYGLUCOSE F18

Showing 1 to 7 of 7 entries

FLUDEOXYGLUCOSE F18 Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Fludeoxyglucose F18

Introduction to Fludeoxyglucose F18

Fludeoxyglucose F18 (FDG), a glucose analog, is a pivotal radiopharmaceutical used in positron emission tomography (PET) imaging. It concentrates in cells that rely on glucose as an energy source, making it essential for diagnosing and monitoring various diseases, particularly cancer, neurological disorders, and cardiovascular diseases[2][3][4].

Market Size and Growth Projections

The global fluorine-18 market, which includes FDG, was valued at approximately US$ 1.4 billion in 2020. It is projected to expand significantly, reaching around US$ 3 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 7.4% to 7.5% from 2021 to 2030[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Chronic Diseases

The rising incidence of cancer, Alzheimer’s disease, and cardiovascular diseases is a major driver of the FDG market. The global cancer incidence is projected to reach over 29 million cases by 2040, which significantly amplifies the need for effective diagnostic tools like FDG[3].

Technological Advancements

Advancements in PET imaging technology and the integration of advanced imaging techniques in clinical practices have accelerated the adoption of FDG. The implementation of cyclotron technology has improved production efficiency, meeting the growing market demand[3].

Healthcare Infrastructure Expansion

The global expansion of healthcare infrastructure, particularly in emerging markets like Asia Pacific, is creating new opportunities. Hospitals and diagnostic centers in these regions are adopting advanced imaging technologies, improving the accessibility of FDG[3][4].

Market Segmentation

By Product

The FDG segment is expected to dominate the global fluorine-18 market by 2030 due to the high demand for PET/CT scans in oncology. Other products like NaF also play a role, but FDG remains the most widely used[1][4].

By End User

Hospitals are the major end users, driven by the increasing demand for the installation of new PET-CT machines in hospital projects globally. Diagnostic centers and other healthcare facilities also contribute to the market growth[1][4].

By Region

North America, particularly the United States, dominates the global fluorine-18 market due to robust investments in nuclear medicine and a high prevalence of chronic diseases. The Asia Pacific region is expected to expand at a high CAGR, driven by product launches, acquisitions, and geographical expansion by local players in China and India[1][3][4].

Competitive Landscape

The market is characterized by rapid innovation and strategic collaborations among key players such as Lantheus Holdings, Inc., Siemens Healthineers, Advanced Accelerator Applications (a Novartis AG Company), GE Healthcare (General Electric Company), and Blue Earth Diagnostics (A Bracco Imaging Company). These companies are enhancing their production capabilities and optimizing their formulations to meet the growing demand[1][3].

Challenges and Restraints

Despite the growth, the market faces challenges such as high production costs, regulatory barriers, and competition from alternative diagnostic agents. These factors must be navigated carefully to ensure sustained market growth[3].

Mechanism of Action and Clinical Use

FDG is transported into cells through facilitative glucose transporter proteins and phosphorylated by the enzyme hexokinase. This mechanism allows clinicians to visualize metabolic activity in tissues, which is crucial for early diagnosis and treatment planning of various diseases. For instance, in cardiology, FDG helps identify myocardial segments with reversible or irreversible loss of systolic function[2].

Pharmacokinetics and Safety

The pharmacokinetics of FDG involve a triexponential decay curve with effective half-lives ranging from minutes to hours. It is primarily excreted in the urine, with clearance from most tissues within 24 hours. Extensive dose range and dose adjustment studies have been conducted, particularly in special populations like pediatric patients[2].

Regional Insights

  • North America: Dominates the global market due to significant investments in nuclear medicine and a high prevalence of chronic diseases.
  • Europe: Follows North America in market share, with countries like Germany, the U.K., and France contributing substantially.
  • Asia Pacific: Expected to grow at a high CAGR, driven by emerging markets in China and India.
  • Latin America and Middle East & Africa: Also show potential for growth, though at a slower pace compared to other regions[1][3][4].

Future Outlook

The FDG market is poised for significant growth driven by advancements in diagnostic imaging and the increasing demand for precision medicine. As healthcare providers adopt PET imaging more widely due to its superior ability to visualize metabolic activity, the market is expected to expand further[3].

Key Takeaways

  • The global fluorine-18 market, including FDG, is projected to reach US$ 3 billion by 2030.
  • The FDG segment will dominate the market due to high demand in oncology.
  • North America and Europe are current leaders, with Asia Pacific showing high growth potential.
  • Technological advancements and expanding healthcare infrastructure drive market growth.
  • High production costs and regulatory barriers are key challenges.

Frequently Asked Questions (FAQs)

1. What is the primary use of Fludeoxyglucose F18 (FDG) in medical diagnostics?

FDG is primarily used in positron emission tomography (PET) imaging to visualize metabolic activity in tissues, aiding in the diagnosis and monitoring of diseases like cancer, neurological disorders, and cardiovascular diseases.

2. What are the key drivers of the FDG market growth?

The key drivers include the increasing prevalence of chronic diseases, technological advancements in PET imaging, and the expansion of healthcare infrastructure, particularly in emerging markets.

3. Which region dominates the global fluorine-18 market?

North America, particularly the United States, dominates the global fluorine-18 market due to robust investments in nuclear medicine and a high prevalence of chronic diseases.

4. What are the main challenges facing the FDG market?

High production costs, regulatory barriers, and competition from alternative diagnostic agents are the main challenges facing the FDG market.

5. How is FDG metabolized and excreted in the body?

FDG is transported into cells, phosphorylated by hexokinase, and then excreted primarily in the urine, with clearance from most tissues within 24 hours[2].

Sources:

  1. Transparency Market Research - Fluorine-18 Market Insight and Trends 2031
  2. FDA - Fludeoxyglucose F 18 Injection Label
  3. PMR - Worldwide Fludeoxyglucose F 18 Injection Market Research 2024
  4. BioSpace - Fluorine-18 Market Size Worth Around US$ 3 Billion by 2030

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