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:	121
Patent Applications:	29
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
The University of Hong Kong	N/A
Universidade Federal do Para	Phase 3
Sun Yat-sen University	Phase 2

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
Ncm Usa Bronx Llc	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	204513-001	Nov 28, 2014	AP	RX	No	No
Mips Crf	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	204517-001	Jul 21, 2015	AP	RX	No	No
Bamf	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	216126-001	Dec 6, 2022	AP	RX	No	No
Sofie	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	203544-001	Dec 26, 2012		DISCN	No	No
Midwest Medcl	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	204440-001	Nov 17, 2015	AP	RX	No	No
Univ Utah Cyclotron	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	204497-001	Apr 20, 2015	AP	RX	No	No
Precision Nuclear	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	204542-001	Feb 27, 2015	AP	RX	No	No

SODIUM FLUORIDE F-18 Market Analysis and Financial Projection Experimental

Sodium Fluoride F-18 Market Dynamics and Financial Trajectory

Introduction

Sodium Fluoride F-18, a diagnostic radiopharmaceutical, is gaining significant traction in the medical field, particularly in the realm of bone imaging. Here, we delve into the market dynamics and financial trajectory of this crucial diagnostic agent.

Market Definition and Scope

Sodium Fluoride F-18 is a positron-emitting radiopharmaceutical used in conjunction with Positron Emission Tomography (PET) imaging to delineate areas of altered osteogenic activity. It is primarily indicated for bone imaging, making it a vital tool in diagnosing various bone-related conditions[3].

Market Growth Drivers

Several factors are driving the growth of the Sodium Fluoride F-18 market:

Increasing Prevalence of Diseases

The global rise in diseases such as cancer, Alzheimer’s, and cardiovascular diseases is increasing the demand for precise diagnostic tools. This trend is particularly evident in the demand for Fluorine-18 (F-18) isotopes, which includes Sodium Fluoride F-18[1].

Advancements in PET Technology

Recent advancements in PET technology have renewed interest in Sodium Fluoride F-18 for detecting bone metastases in cancer patients. Studies have shown that 18F-NaF PET and 18F-NaF PET/CT are superior to conventional methods for bone imaging[2].

Health Awareness and PET/CT Scans

The growing preference for PET/CT scans due to rising health awareness is another key factor propelling market growth. In developed countries, the high demand for cancer scan procedures is driving the dominance of the FDG segment, which also benefits the Sodium Fluoride F-18 market[1].

Regional Market Insights

The market for Sodium Fluoride F-18 is geographically diverse, with several regions contributing to its growth:

North America and Europe

These regions are significant due to their well-established healthcare systems and high demand for advanced diagnostic tools. The market in these regions is forecasted to grow steadily, driven by the increasing need for PET imaging in healthcare sectors[1].

Asia Pacific

The Asia Pacific region, particularly countries like India and China, is offering notable opportunities for F-18 producers. The rise in demand for health testing purposes and the growing healthcare expenditure in these countries are key drivers of market growth[1].

Financial Trajectory

The financial outlook for the Sodium Fluoride F-18 market is promising:

Current Market Value

The global Fluorine-18 market, which includes Sodium Fluoride F-18, was valued over US$ 1.5 billion in 2020[1].

Projected Growth

This market is projected to expand at a Compound Annual Growth Rate (CAGR) of 7.5% from 2021 to 2031, with the market expected to cross US$ 3 billion by 2031[1].

Segment Dominance

The FDG segment, which is closely related to the use of F-18 isotopes like Sodium Fluoride F-18, is expected to account for a major share of the global market by 2031. This is due to the increasing demand for PET/CT scans in oncology[1].

Key Players

Several key players are driving the market forward:

• Lantheus Holdings, Inc.
• Siemens Healthineers
• Advanced Accelerator Applications (a Novartis AG Company)
• GE Healthcare (General Electric Company)
• Blue Earth Diagnostics (A Bracco Imaging Company)[1]

Pharmacological and Clinical Aspects

Sodium Fluoride F-18 has several pharmacological and clinical advantages:

Pharmacokinetics

Following intravenous administration, Sodium Fluoride F-18 ions rapidly equilibrate with the extracellular fluid space and are then cleared by bone deposition and renal excretion. The ions do not bind to serum proteins, and their clearance from the body is rapid, with 20% or more cleared in urine within the first two hours[2][3].

Indications

It is indicated for various bone-related conditions, including back pain, osteomyelitis, trauma, inflammatory and degenerative arthritis, and metabolic bone diseases. Its uptake mechanism reflects blood flow and bone remodeling, making it highly sensitive for detecting skeletal abnormalities[3].

Regulatory and Safety Aspects

Sodium Fluoride F-18 has a well-established regulatory history:

FDA Approval

The FDA approved Sodium Fluoride F-18 Injection as a bone imaging agent in 1972, although its marketing was temporarily halted with the introduction of 99Tc-labeled diphosphonate compounds. Recent PET technology advancements have revived its use[2].

Safety Profile

No adverse reactions have been reported, and the drug is generally safe when used as indicated. However, the lethal dose of NaF for an average adult is estimated to be between 32 to 64 mg fluoride/kg body weight[3].

Market Attractiveness Analysis

The market attractiveness of Sodium Fluoride F-18 can be analyzed based on several factors:

By Product

The FDG segment dominates, but Sodium Fluoride F-18 is gaining traction due to its specific indications and superior diagnostic capabilities[1].

By End-user

Hospitals and diagnostic centers are the primary end-users, with a growing demand driven by the need for precise diagnostic tools[1].

By Region

Asia Pacific countries are emerging as significant markets due to increasing healthcare expenditure and infrastructure expansions[1].

Key Takeaways

• The Sodium Fluoride F-18 market is driven by the increasing need for PET imaging in healthcare.
• The market is projected to grow at a CAGR of 7.5% from 2021 to 2031.
• Key players include major healthcare and diagnostic companies.
• The drug has a strong pharmacological profile with rapid clearance and high sensitivity for bone imaging.
• Regulatory approvals and safety profiles support its continued use.

Frequently Asked Questions (FAQs)

Q: What is the primary indication for Sodium Fluoride F-18? A: Sodium Fluoride F-18 is primarily indicated as a bone imaging agent to define areas of altered osteogenic activity[3].

Q: Which regions are driving the growth of the Sodium Fluoride F-18 market? A: The Asia Pacific region, particularly countries like India and China, along with North America and Europe, are driving the market growth[1].

Q: What is the projected market value of the Fluorine-18 market by 2031? A: The Fluorine-18 market, which includes Sodium Fluoride F-18, is projected to cross US$ 3 billion by 2031[1].

Q: How does Sodium Fluoride F-18 compare to other bone imaging agents? A: Sodium Fluoride F-18 has better pharmacokinetic characteristics, including faster blood clearance and higher uptake in bone, making it superior to conventional methods[3].

Q: Are there any adverse reactions associated with Sodium Fluoride F-18? A: No adverse reactions have been reported for Sodium Fluoride F-18 when used as indicated[3].

Sources:

1. Transparency Market Research - Fluorine-18 Market Insight and Trends 2031
2. Cancer Imaging Program - Sodium Fluoride F 18 Injection Investigator’s Brochure
3. DrugBank - Fluoride ion F-18: Uses, Interactions, Mechanism of Action