Fludeoxyglucose f-18 - Generic Drug Details

What are the generic drug sources for fludeoxyglucose f-18 and what is the scope of freedom to operate?

Fludeoxyglucose f-18 is the generic ingredient in one branded 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. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for fludeoxyglucose f-18. Twenty-six suppliers are listed for this compound.

Summary for fludeoxyglucose f-18

US Patents:	0
Tradenames:	1
Applicants:	41
NDAs:	44
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	198
What excipients (inactive ingredients) are in fludeoxyglucose f-18?	fludeoxyglucose f-18 excipients list
DailyMed Link:	fludeoxyglucose f-18 at DailyMed

Recent Clinical Trials for fludeoxyglucose f-18

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

Sponsor	Phase
City of Hope Medical Center	PHASE1
National Cancer Institute (NCI)	PHASE1
AbbVie	PHASE2

See all fludeoxyglucose f-18 clinical trials

Pharmacology for fludeoxyglucose f-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

Anatomical Therapeutic Chemical (ATC) Classes for fludeoxyglucose f-18

B05CX	Other irrigating solutions
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

V04CA	Tests for diabetes
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

V06DC	Carbohydrates
V06D	OTHER NUTRIENTS
V06	GENERAL NUTRIENTS
V	Various

US Patents and Regulatory Information for fludeoxyglucose f-18

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Univ Utah Cyclotron	FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	204498-001	Jun 23, 2015	AP	RX	No	No
Mem Sloan-kettering	FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	208679-001	Dec 8, 2016		DISCN	No	No
Wusm Cyclotron	FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	203935-001	Feb 5, 2014	AP	RX	No	No

Market Dynamics and Financial Trajectory for Fluorodeoxyglucose F-18 (FDG)

Last updated: February 13, 2026

Overview

Fluorodeoxyglucose F-18 (FDG) is a radiopharmaceutical primarily used in positron emission tomography (PET) imaging. Its widespread application in oncology, neurology, and cardiology drives its demand.

Market Size and Growth

The global FDG PET imaging market was valued at approximately $1.8 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of about 6.5% from 2023 to 2030, reaching nearly $3.4 billion by 2030. Growth drivers include increasing cancer prevalence, advancements in PET imaging technology, and expanding clinical applications.

Key Market Drivers

• Oncology Focus: FDG is the most common radiotracer for cancer detection, staging, and monitoring. The rising incidence of cancers such as lung, lymphoma, and melanoma sustains demand.
• Neurology and Cardiology: Use in diagnosing Alzheimer’s disease and myocardial viability expands the market.
• Technological Advancements: Improvements in PET scanner resolution and hybrid imaging (PET/CT, PET/MRI) enhance diagnostic accuracy.
• Regulatory Approvals: Clearances by agencies such as the FDA for broader indications encourage adoption.

Competitive Landscape

Leading suppliers include:

• Lantheus Medical Imaging: Dominates the US market via its product Fluorodeoxyglucose F-18.
• Nordion (Canada): Supplies bulk FDG for distribution.
• Advanced Accelerator Applications (a Novartis company): Focuses on radiopharmaceuticals including FDG.
• Emerging firms: Invest in manufacturing capacity, with some developing alternative radiotracers.

Manufacturing and Supply Chain

FDG’s short half-life of approximately 110 minutes necessitates centralized production facilities near hospitals. The supply chain involves:

• Cyclotron facilities: Produce F-18 isotopes onsite or nearby.
• Radiosynthesis units: Convert F-18 into FDG.
• Distribution logistics: Must ensure timely delivery within the half-life window.

Manufacturers invest heavily in cyclotron and radiochemistry infrastructure, constraining supply expansion and affecting pricing.

Pricing Trends

In the US, the average cost per dose ranges from $600 to $800, influenced by production costs, regulatory compliance, and reimbursement policies. Reimbursement rates from CMS generally range between $900 and $1,200 per scan, incentivizing providers to maximize utilization.

Regulatory and Policy Impact

FDA approvals and CMS reimbursement policies significantly influence the market. Recent approvals for alternative tracers and shifts toward personalized medicine may impact FDG demand margins.

Financial Trajectory

• Revenue Growth: Expected to grow at a 6.5% CAGR through 2030, driven by increased clinical adoption and facility expansion.
• Investment Trends: Companies continue investing in cyclotron capacity, R&D for novel tracers, and supply chain resilience.
• Price Sensitivity: Supply constraints and competitive pricing exert downward pressure on per-dose costs.

Emerging Opportunities

• Theranostics: Combining diagnostic and therapeutic options offers potential for market expansion.
• Automation and digitization: Enhances production efficiency and supply chain reliability.
• Regional expansion: Emerging markets in Asia Pacific, Latin America, and Africa represent growth opportunities due to increasing healthcare infrastructure.

Risks and Challenges

• Manufacturing complexity: The need for on-site cyclotrons limits scalable expansion.
• Regulatory hurdles: Stringent approval processes constrain product innovations.
• Market saturation in mature regions: Growth slows as penetration reaches ceiling levels.

Key Takeaways

FDG’s role in PET imaging ensures steady demand, driven by the rise in cancer diagnosis and advancements in imaging tech. Market growth depends on supply chain management, regulatory environment, and competition. The financial outlook remains positive, with sustained CAGR near 6.5%, but is sensitive to technological, regulatory, and regional factors.

FAQs

1. What factors influence FDG pricing?
   Manufacturing costs, regulatory compliance, supply chain logistics, competition, and reimbursement policies all shape pricing structures.

2. How does regulatory approval impact FDG market growth?
   FDA and other agencies’ approvals for new indications or formulations expand market access, driving demand.

3. What regional markets show the highest growth potential?
   Emerging markets in Asia Pacific and Latin America, due to expanding healthcare infrastructure, present significant growth opportunities.

4. Are there alternatives to FDG in PET imaging?
   Yes, tracers like 68Ga-PSMA or 18F-FAZA are in development, offering alternatives for specific indications.

5. What future innovations could influence FDG’s market?
   Advances in cyclotron technology, integration of AI for image analysis, and development of theranostic pairs may alter demand and application scope.

Sources

[1] MarketsandMarkets, “PET Imaging Market,” 2023.
[2] GlobalData Healthcare, “Radiopharmaceuticals Market Analysis,” 2022.
[3] U.S. Food and Drug Administration (FDA), “Regulatory Status of PET Radiopharmaceuticals,” 2022.
[4] License and reimbursement data from CMS and industry reports.