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, 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. 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:	43
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	183
Patent Applications:	1,672
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
Robert Flavell, MD, PhD	Phase 1
Michael Topf	Phase 1
Xencor, Inc.	Phase 1

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
Isologic Innovative	FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	204525-001	Oct 29, 2014	AP	RX	No	No
Hot Shots Nm Llc	FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	203937-001	Oct 30, 2014		DISCN	No	No
Biomedcl Res Fdn	FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	203710-001	May 1, 2015	AP	RX	No	No
Mem Sloan-kettering	FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	208679-001	Dec 8, 2016	AP	RX	No	No
Feinstein	FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	021870-002	Nov 21, 2008	AP	RX	Yes	Yes

Fludeoxyglucose f-18 Market Analysis and Financial Projection Experimental

Fluorine-18 and Fludeoxyglucose F-18: Market Dynamics and Financial Trajectory

Introduction

Fluorine-18, particularly in the form of Fludeoxyglucose F-18 (FDG), is a crucial radionuclide in the field of positron emission tomography (PET). This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of the Fluorine-18 market, with a special focus on FDG.

Market Size and Growth

The global Fluorine-18 market was valued at approximately US$ 1.4 billion in 2020 and is projected to reach US$ 3 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 7.4% from 2021 to 2030[4].

Key Drivers of Market Growth

Several factors are driving the growth of the Fluorine-18 market:

Increasing Demand for PET/CT Scans

The rising prevalence of diseases such as cancer, Alzheimer’s, and cardiovascular diseases is driving the demand for more precise diagnostic tools like PET/CT scans. FDG, being the most widely used PET-radiopharmaceutical, is particularly in high demand for oncology applications[1][4].

Technological Advancements

Advancements in research and technology are making PET/CT imaging more accessible and affordable. Manufacturers are focusing on reducing the setup costs for PET/CT systems, which is expected to increase adoption in developing countries[1].

Health Awareness and Preference

There is a growing preference among individuals to undergo PET/CT scans due to increasing health awareness. This trend is further propelled by the non-invasive nature and effectiveness of PET/CT scans in evaluating disease progression and treatment outcomes[1].

Market Segmentation

The Fluorine-18 market is segmented based on product, end-user, and region.

Product Segmentation

• FDG: This segment is expected to dominate the market by 2030 due to its widespread use in oncology for cancer diagnosis and management.
• NaF: Used primarily for bone scans.
• Others: Includes other radiopharmaceuticals using Fluorine-18[1][4].

End-User Segmentation

• Hospitals: Expected to be the major end-users, driven by the increasing demand for PET/CT machines in new hospital projects.
• Diagnostic Centers: Also significant, as these centers are expanding their capabilities to include PET/CT scans.
• Others: Includes research institutions and other healthcare facilities[4].

Regional Segmentation

• North America: Currently dominates the global market, followed by Europe.
• Asia Pacific: Projected to grow at a high CAGR, driven by product launches, acquisitions, and geographical expansion by local players in countries like China and India[4].

Financial Aspects of FDG Production

The production cost of FDG is a critical factor in the market's financial trajectory.

Cost Components

An activity-based costing (ABC) analysis reveals that the cost of FDG production is influenced by several components:

• Personnel Costs: Significant due to the need for skilled labor.
• Equipment Costs: High, but decreasing with advancements in technology.
• Consumables: Includes costs for raw materials and other consumable items.
• Overhead and Space Costs: Important for maintaining compliance with regulatory requirements[2].

Pricing

The cost of FDG can vary from 300 to 500 Euro per patient dose in Europe, depending on the production configuration and regulatory compliance[2].

Competitive Landscape

The market is competitive, with several key players:

• 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.[4].

These companies are engaged in various strategies such as product launches, acquisitions, and distribution agreements to maintain their market share.

Regulatory and Quality Assurance

The production of FDG must adhere to strict regulatory guidelines, including Good Manufacturing Practices (GMP) and quality assurance protocols. This ensures the product is safe for human use and meets the required quality specifications[5].

Future Outlook

The future growth of the Fluorine-18 market, particularly the FDG segment, is promising due to several factors:

• Increasing Inclination Towards Radionuclide Medicine: PET/CT scans are becoming more preferred for diagnosing and monitoring diseases.
• Technological Advancements: Making PET/CT systems more affordable and accessible.
• Growing Demand in Developing Countries: Asia Pacific countries like India and China are offering significant opportunities for market growth[1][4].

"2-[18F]-fluoro-2-deoxy-D-glucose (FDG) is the most successful and widely used imaging agent in PET today. While FDG is utilized largely in oncology for the management of cancer patients, its applications in neurology and cardiology are also steadily growing."[5]

Key Takeaways

• The Fluorine-18 market is projected to reach US$ 3 billion by 2030, growing at a CAGR of 7.4% from 2021 to 2030.
• FDG is the dominant product segment due to its high demand in oncology.
• Hospitals are the major end-users, with Asia Pacific regions showing high growth potential.
• The market is driven by increasing health awareness, technological advancements, and the need for precise diagnostic tools.
• Regulatory compliance and quality assurance are critical for FDG production.

FAQs

What is the primary use of Fluorine-18 in medical imaging?

Fluorine-18, particularly in the form of FDG, is primarily used in positron emission tomography (PET) for diagnosing and managing diseases such as cancer, Alzheimer’s, and cardiovascular diseases.

What are the key drivers of the Fluorine-18 market growth?

The key drivers include increasing demand for PET/CT scans, technological advancements making PET/CT systems more affordable, and growing health awareness among individuals.

Which region is expected to show the highest growth in the Fluorine-18 market?

The Asia Pacific region is projected to grow at a high CAGR due to product launches, acquisitions, and geographical expansion by local players in countries like China and India.

What are the main cost components in the production of FDG?

The main cost components include personnel costs, equipment costs, consumables, and overhead and space costs.

Who are the major players in the Fluorine-18 market?

Major players include Lantheus Holdings, Inc., Siemens Healthineers, Advanced Accelerator Applications, GE Healthcare, and Blue Earth Diagnostics, among others.

Sources

1. Transparency Market Research - Fluorine-18 Market Insight and Trends 2031
2. PubMed - Activity-based costing evaluation of [18F]-fludeoxyglucose production
3. PMR - Worldwide Fludeoxyglucose F 18 Injection Market Research 2024
4. BioSpace - Fluorine-18 Market Size Worth Around US$ 3 Billion by 2030
5. IAEA - Cyclotron Produced Radionuclides: Guidance on Facility Design and Operation