Last Updated: June 25, 2026

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, Bamf, Biomedcl Res Fdn, Brigham Womens, Cardinal Health 414, Childrens Hosp Mi, 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-four NDAs.

The generic ingredient in FLUDEOXYGLUCOSE F18 is fludeoxyglucose f-18. There are eight drug master file entries for this compound. Twenty-five 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:44
Finished Product Suppliers / Packagers: 25
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 198
Patent Applications: 328
What excipients (inactive ingredients) are in FLUDEOXYGLUCOSE F18?FLUDEOXYGLUCOSE F18 excipients list
DailyMed Link:FLUDEOXYGLUCOSE F18 at DailyMed
Recent Clinical Trials for FLUDEOXYGLUCOSE F18

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

SponsorPhase
City of Hope Medical CenterPHASE1
National Cancer Institute (NCI)PHASE1
AbbViePHASE2

See all FLUDEOXYGLUCOSE F18 clinical trials

Pharmacology for FLUDEOXYGLUCOSE F18

US Patents and Regulatory Information for FLUDEOXYGLUCOSE F18

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Univ Southern Ca FLUDEOXYGLUCOSE F18 fludeoxyglucose f-18 INJECTABLE;INTRAVENOUS 209341-001 Dec 16, 2020 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Queen Hamamatsu Pet FLUDEOXYGLUCOSE F18 fludeoxyglucose f-18 INJECTABLE;INTRAVENOUS 203771-001 Aug 31, 2015 AP RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Univ Utah Cyclotron FLUDEOXYGLUCOSE F18 fludeoxyglucose f-18 INJECTABLE;INTRAVENOUS 204498-001 Jun 23, 2015 AP RX No 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 Fluorodeoxyglucose F18 (FDG F18)

Last updated: February 3, 2026

Summary

Fluorodeoxyglucose F18 (FDG F18) is a radiopharmaceutical predominantly used in positron emission tomography (PET) imaging. Its critical role in oncology, neurology, and cardiology has driven rapid market growth, with projections showing sustained expansion through 2030. The global FDG F18 market, valued at approximately USD 750 million in 2022, is expected to reach USD 1.3 billion by 2030, growing at a compound annual growth rate (CAGR) of around 7%. This growth trajectory hinges on technological advances, expanding clinical applications, regulatory approvals, and supply chain dynamics.


1. Market Size and Growth Outlook

Year Estimated Market Size (USD Millions) Growth Rate (%)
2022 750
2023 803 7.0
2024 860 7.0
2025 922 7.0
2026 987 7.0
2027 1058 7.0
2028 1134 7.0
2029 1216 7.0
2030 1304 7.0

Source: Market Research Future (MRFR) 2022, based on CAGR projections.


2. Key Market Drivers

2.1. Rising Adoption in Oncology

  • FDG F18 is the primary radiotracer for cancer detection, particularly in lung, breast, lymphoma, and melanoma.
  • The global burden of cancer is rising, with WHO reporting 19.3 million new cases in 2020, boosting demand for diagnostic imaging.

2.2. Technological Advancements

  • Innovations in PET/CT and PET/MRI systems enhance diagnostic accuracy.
  • Development of automated synthesis modules improves production consistency and safety.

2.3. Expansion in Developing Regions

  • Increasing healthcare infrastructure and rising awareness drive adoption in Asia-Pacific, Latin America, and Middle East.
  • Government initiatives and investments in nuclear medicine are accelerating market penetration.

2.4. Regulatory Approvals and Reimbursements

  • Increased regulatory approvals, including those from FDA and EMA, facilitate market expansion.
  • Reimbursement policies in developed countries foster clinical utilization.

2.5. Novel Indications and Therapies

  • Use of FDG F18 in neurodegenerative disorders, cardiovascular diseases, and infection imaging broadens revenue streams.

3. Market Restraints and Challenges

Factor Description
Supply Chain Constraints Limited production centers and short half-life (110 min) create logistical challenges.
High Production Costs Synthesis requires cyclotrons and specialized facilities, impacting profit margins.
Regulatory Hurdles Stringent approval processes for new indications or formulations.
Competition from Alternatives Emerging tracers like Gallium-68 compounds; non-radioactive imaging modalities.

4. Competitive Landscape

Company Market Share (2022) Key Products Geographical Presence
Cardinal Health 25% IBA and Covidien Radiopharmaceuticals Global
Siemens Healthineers 20% PETNET Solutions Global
Nordion (Canada) 15% Radioisotope production North America, Europe
Jubilant Radiopharma 10% FDG F18 production North America
Other 30% Various Global

Note: Market shares are estimates; data sourced from industry reports (e.g., MedMarketWatch, 2022).


5. Supply Chain and Production Dynamics

5.1. Production Architecture

  • Cyclotrons are essential for isotope synthesis, mainly located in major medical centers.
  • Distribution Networks depend on rapid logistics due to short half-life.

5.2. Distribution Challenges

  • Limited production facilities lead to supply bottlenecks.
  • Cold chain logistics imperative for maintaining radiochemical stability during transit.

5.3. Emerging Trends

  • Decentralized production via mobile cyclotrons.
  • Partnerships between hospitals and radiopharmacies to ensure supply.

6. Regional Market Analysis

Region Key Trends Market Size (2022) Estimated CAGR Major Players
North America Dominant due to high adoption, advanced healthcare USD 300M 6.5% Cardinal Health, Jubilant
Europe Growing use, regulatory facilitation USD 200M 7.0% Siemens, Curium Pharma
Asia-Pacific Rapid growth, expanding infrastructure USD 150M 9.0% NCI Pharmaceuticals, YZ Pathways
Latin America & MEA Emerging markets, increasing awareness USD 100M 8.0% Local providers

7. Financial Trajectory and Investment Outlook

7.1. Revenue Projections

  • Increasing demand correlates with rising sales volumes.
  • Synthesis costs range between USD 1,000–3,000 per dose, influencing profit margins.
  • Potential for market penetration via outsourced synthesis and regional production.

7.2. Capital Investment Trends

  • Cross-industry investment in cyclotron infrastructure (~USD 10–50M per facility).
  • Funding for R&D in new radiotracers and improved synthesis technologies.

8. Deepening into Medical and Commercial Applications

8.1. Oncology

Application Estimated Market Share (2022) Growth Drivers
Cancer detection and staging 65% High diagnostic accuracy, treatment planning

8.2. Neurology

Application Estimated Market Share (2022) Growth Drivers
Alzheimer’s and Parkinson’s diagnosis 20% Increased focus on neurodegenerative research

8.3. Cardiology

Application Estimated Market Share (2022) Growth Drivers
Myocardial viability assessment 10% Growing prevalence of ischemic heart disease

9. Comparisons: FDG F18 vs Emerging PET Tracers

Parameter FDG F18 Gallium-68 Tracers Novel Tracers (e.g., FAPI, PSMA)
Half-life 110 min 68 min Varies
Production Cyclotron-based Generators Cyclotron or generator
Cost Lower due to widespread production Higher Varies
Usage Oncology, neurology, cardiology Specific tumor types Emerging indications

Key Takeaways

  • The FDG F18 market is poised for consistent growth driven by expanding clinical utility, technological improvements, and regional healthcare investments.
  • Supply chain and logistical challenges remain critical constraints; decentralization and infrastructure development are vital.
  • Diagnostic dominance in oncology presents sustained revenue streams, complemented by emerging indications in neurology and cardiology.
  • Competitive players are investing heavily in production infrastructure, automation, and regional expansion.
  • Regulatory pathways are becoming streamlined, especially in mature markets, fostering faster clinical adoption.

FAQs

1. What factors influence the cost of FDG F18 production?
Production costs are driven by cyclotron operation expenses, radiopharmaceutical synthesis complexity, logistical logistics, and regulatory compliance, averaging USD 1,000–3,000 per dose.

2. How does the short half-life of FDG F18 impact market supply?
The 110-minute half-life necessitates rapid production and distribution, limiting geographic reach. It requires centralized or decentralized cyclotron facilities nearby clinical sites to ensure timely availability.

3. What are the primary regulatory considerations for FDG F18?
Regulatory agencies require proof of safety, efficacy, and consistent manufacturing practices. Approvals vary by country but generally follow strict protocols under bodies like the FDA and EMA.

4. How does regional market disparity affect global supply chains?
Developed regions have well-established distribution channels and infrastructure, whereas emerging markets may face supply delays due to limited facilities, impacting access and market penetration.

5. What innovations could reshape the FDG F18 market?
Advancements include mobile cyclotrons, automation in synthesis, alternative radiotracers with longer half-lives, and integrated imaging systems improving diagnostic accuracy and patient throughput.


References

  1. Market Research Future (MRFR), "Global PET Tracers Market," 2022.
  2. World Health Organization (WHO), "Cancer Fact Sheet," 2021.
  3. MedMarketWatch, "Nuclear Medicine Radiopharmaceuticals Report," 2022.
  4. Siemens Healthineers Press Release, "Advances in PET Imaging," 2021.
  5. US Food and Drug Administration (FDA), "Radiopharmaceutical Approvals," 2022.

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