SODIUM FLUORIDE F-18 - Generic Drug Details

What are the generic sources for sodium fluoride f-18 and what is the scope of patent protection?

Sodium fluoride f-18 is the generic ingredient in three branded drugs marketed by Ge Healthcare, Nih Nci Dctd, 3d Imaging Drug, Bamf, Biomedcl Res Fdn, Cardinal Health 414, Decatur, Essential Isotopes, Hot Shots Nm Llc, Jubilant Draximage, Kreitchman Pet Ctr, Mcprf, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Nukemed, Petnet, Precision Nuclear, Shertech Labs Llc, Sofie, The Feinstein Inst, Ucsf Rodiopharm, Uihc Pet Imaging, Univ Tx Md Anderson, and Univ Utah Cyclotron, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for SODIUM FLUORIDE F-18

US Patents:	0
Tradenames:	3
Applicants:	25
NDAs:	26
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	144
What excipients (inactive ingredients) are in SODIUM FLUORIDE F-18?	SODIUM FLUORIDE F-18 excipients list
DailyMed Link:	SODIUM FLUORIDE F-18 at DailyMed

Recent Clinical Trials for SODIUM FLUORIDE F-18

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

Sponsor	Phase
Anabio R&D	NA
Hanoi Medical University	NA
Assiut University	NA

See all SODIUM FLUORIDE F-18 clinical trials

Pharmacology for SODIUM FLUORIDE F-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

Medical Subject Heading (MeSH) Categories for SODIUM FLUORIDE F-18

Cariostatic Agents

Anatomical Therapeutic Chemical (ATC) Classes for SODIUM FLUORIDE F-18

A01AA	Caries prophylactic agents
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A12CD	Fluoride
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for SODIUM FLUORIDE F-18

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Decatur	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	204464-001	Oct 21, 2014		DISCN	No	No
Sofie	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	203592-001	Aug 18, 2015	AP	RX	No	No
Midwest Medcl	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	204440-001	Nov 17, 2015	AP	RX	No	No
Ge Healthcare	FLUORINE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	017042-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Market Dynamics and Financial Trajectory for Sodium Fluoride F-18

Last updated: July 29, 2025

Introduction

Sodium Fluoride F-18 ((^{18})F-NaF) is a radiopharmaceutical largely adopted in nuclear medicine for PET imaging, specifically in detecting and evaluating skeletal metastases and metabolic bone diseases. Its growth trajectory is influenced by technological advancements, regulatory landscapes, clinical preferences, and the expanding scope of nuclear imaging. This analysis explores the current market dynamics, growth drivers, challenges, and future financial prospects of sodium fluoride F-18, providing stakeholders with actionable insights.

Market Overview

Sodium Fluoride F-18 has experienced increased adoption owing to its superior imaging qualities over conventional bone scans. Its high affinity for hydroxyapatite enhances lesion detection, increasing sensitivity and specificity in bone metastasis diagnosis. The global demand aligns with broader trends in nuclear medicine, which is experiencing steady growth driven by technological progress, aging populations, and the rising prevalence of cancer metastasis.

Market Drivers

1. Rising Incidence of Bone Metastases and Skeletal Diseases

Cancer patients, especially those with breast, prostate, and lung cancers, frequently develop bone metastases. According to the American Cancer Society, approximately 70% of advanced breast and prostate cancer patients exhibit skeletal involvement. The rising cancer incidence globally increases the need for accurate diagnostic tools like (^{18})F-NaF PET scans, fueling market growth.

2. Superior Imaging Capabilities Over Traditional Techniques

Compared to Technetium-99m labeled agents, (^{18})F-NaF offers enhanced image resolution, rapid kinetics, and lower radiation doses. These advantages lead to improved diagnostic accuracy, prompting wider clinical acceptance and increasing procedural volume.

3. Technological Advancements and Expanding PET Infrastructure

The proliferation of PET/CT scanners globally, including in emerging markets, directly supports the demand for (^{18})F-based radiopharmaceuticals. Innovations in production methods, such as automated synthesis and on-site cycloton infrastructure, have streamlined supply chains and reduced costs, boosting market uptake.

4. Regulatory Approvals and Clinical Guidelines

Emerging clinical guidelines endorse (^{18})F-NaF PET imaging as a first-line modality for specific indications, including skeletal metastasis detection, accelerating adoption in clinical practice. Regulatory approvals in multiple regions facilitate broader market penetration.

Market Challenges

1. High Production and Short Shelf-Life Constraints

The half-life of (^{18})F (approximately 110 minutes) necessitates proximity to cyclotron facilities, complicating logistics, especially in remote regions. These logistical hurdles restrain market expansion in areas lacking infrastructure.

2. Competition From Alternative Imaging Agents

Technetium-based bone scans remain prevalent due to established protocols and broader availability. Additionally, advancements in MRI and other functional imaging techniques offer complementary diagnostics, potentially reducing demand for nuclear options.

3. Regulatory and Reimbursement Barriers

Inconsistent regulatory pathways and reimbursement policies across countries hinder rapid market expansion. Cost considerations in healthcare systems also influence procedural adoption.

4. Manufacturing Complexities and Supply Chain Risks

Ensuring consistent supply of high-purity (^{18})F-NaF requires sophisticated infrastructure and supply chain management. Any disruptions impact market stability and trajectory.

Financial Trajectory and Future Outlook

Market Size and Forecasts

The global (^{18})F-NaF market was valued at approximately USD 200-300 million in 2022 and is projected to grow at a CAGR of 6-8% over the next five years. Key factors include increasing cancer burden, technological adoption, and expanding PET scan infrastructure.

Regional Dynamics

• North America: Dominates due to high adoption rates, advanced healthcare infrastructure, and robust R&D investments.
• Europe: Rapid growth driven by regulatory acceptance and aging populations.
• Asia-Pacific: Presents high-growth potential owing to expanding healthcare infrastructure, increasing cancer rates, and rising awareness.

Investment and R&D Trends

Pharmaceutical companies are investing in developing more efficient cyclotron and synthesis techniques, alongside exploring theranostic applications involving (^{18})F. Partnerships between academia, government agencies, and industry aim to optimize production and distribution models.

Emerging Opportunities

• On-site Cyclotron Installations: Reducing lead times and costs, facilitating inpatient and outpatient diagnostics.
• Automated Synthesis Modules: Increasing production consistency and safety.
• Combination Diagnostics: Integrating (^{18})F-NaF with other tracers for comprehensive oncological assessment.

Regulatory and Clinical Policy Impact

Regulatory agencies like the FDA and EMA are increasingly endorsing (^{18})F-NaF, with some approvals being expanded for broader indications. This trend supports market growth and investment. Additionally, evolving clinical guidelines favor PET imaging, contributing to volume increases.

Conclusion

The market dynamics of sodium fluoride F-18 are poised for steady growth, propelled by technological advances, expanding clinical applications, and increasing healthcare investments in nuclear medicine. While logistical and regulatory challenges remain, innovations in production and distribution are likely to mitigate these barriers, enabling broader adoption.

Key Takeaways

• The expanding incidence of bone metastasis is a primary driver for (^{18})F-NaF growth.
• Advances in PET technology and infrastructure underpin future market expansion.
• Regulatory endorsement and clinical guideline updates continue to foster adoption.
• Logistics and supply-chain complexities represent notable hurdles.
• The regional outlook favors North America and Europe presently, with significant growth potential in Asia-Pacific.

FAQs

1. What factors influence the cost of sodium fluoride F-18 radiopharmaceuticals?
Production costs are driven by cyclotron facility expenses, synthesis automation, transportation logistics (due to the isotope's short half-life), and regulatory compliance. Infrastructure investments and supply chain efficiency significantly impact overall costs.

2. How does sodium fluoride F-18 compare to Technetium-99m bone scans?
(^{18})F-NaF PET provides higher sensitivity and specificity, superior image resolution, and faster imaging times. However, it involves higher costs and infrastructure requirements, making technetium-based scans more accessible in certain settings.

3. Which countries present the highest growth potential for (^{18})F-NaF?
Emerging markets in Asia-Pacific, such as China and India, demonstrate substantial growth potential due to expanding healthcare infrastructure and rising cancer prevalence. Europe and North America will continue to lead in adoption rates.

4. What role does automation play in the future of (^{18})F-NaF production?
Automation enhances consistency, reduces human error, and lowers contamination risks. It facilitates compliance with Good Manufacturing Practices (GMP) and allows for scalable production, crucial for meeting increasing demand.

5. Are there emerging therapeutic applications for (^{18})F-based radiopharmaceuticals?
Currently, (^{18})F is predominantly diagnostic. However, theranostic development involving similar isotopes (e.g., (^{18})F-labeled compounds for therapeutic delivery) remains an active research area, promising future expansion.

---

Sources
[1] American Cancer Society. "Cancer Facts & Figures 2022."
[2] Society of Nuclear Medicine and Molecular Imaging. "Guidelines for Bone Imaging."
[3] GlobalData. "Nuclear Medicine Market Report 2022."
[4] World Health Organization. "Cancer Fact Sheet."
[5] FDA. "Regulatory Approvals for PET Radiopharmaceuticals."