You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

SODIUM FLUORIDE F 18 Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Sodium Fluoride F 18, and when can generic versions of Sodium Fluoride F 18 launch?

Sodium Fluoride F 18 is a drug marketed by Nih Nci Dctd and is included in one NDA.

The generic ingredient in SODIUM FLUORIDE F 18 is sodium fluoride f-18. There are one thousand four hundred and seventy-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sodium fluoride f-18 profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sodium Fluoride F 18

A generic version of SODIUM FLUORIDE F 18 was approved as sodium fluoride f-18 by MCPRF on June 28th, 2013.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for SODIUM FLUORIDE F 18?
  • What are the global sales for SODIUM FLUORIDE F 18?
  • What is Average Wholesale Price for SODIUM FLUORIDE F 18?
Summary for SODIUM FLUORIDE F 18
Drug patent expirations by year for SODIUM FLUORIDE F 18
Recent Clinical Trials for SODIUM FLUORIDE F 18

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

SponsorPhase
The University of Hong KongN/A
Universidade Federal do ParaPhase 3
Sun Yat-sen UniversityPhase 2

See all SODIUM FLUORIDE F 18 clinical trials

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
Nih Nci Dctd SODIUM FLUORIDE F 18 sodium fluoride f-18 INJECTABLE;INTRAVENOUS 022494-001 Jan 26, 2011 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

SODIUM FLUORIDE F 18 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sodium Fluoride F 18

Introduction to Sodium Fluoride F 18

Sodium Fluoride F 18, also known as Fluoride ion F-18, is a diagnostic radiopharmaceutical agent primarily used as a bone imaging agent. It is utilized in conjunction with Positron Emission Tomography (PET) to delineate areas of altered osteogenic activity, making it a crucial tool in the diagnosis of various bone-related conditions[2][3].

Market Growth Drivers

Increasing Demand for Precise Diagnostics

The global market for Sodium Fluoride F 18 is driven by the increasing need for precise diagnostic tools, particularly in the healthcare sector. The rising prevalence of diseases such as cancer, Alzheimer’s, and cardiovascular diseases has heightened the demand for advanced diagnostic techniques like PET imaging[4].

Advancements in PET Technology

Recent advancements in PET technology have renewed interest in Sodium Fluoride F 18. Studies have shown that 18F-NaF PET and 18F-NaF PET/CT are superior to conventional methods in detecting bone metastases in cancer patients, which has significantly boosted its market demand[2].

Expanding Applications

Sodium Fluoride F 18 is indicated for a wide range of bone-related conditions, including back pain, osteomyelitis, trauma, inflammatory and degenerative arthritis, avascular necrosis, and metabolic bone diseases. This broad spectrum of applications contributes to its growing market[3].

Regional Market Insights

Asia Pacific Region

The Asia Pacific region, particularly countries like India and China, is experiencing marked growth in the demand for Sodium Fluoride F 18. This is attributed to the increasing healthcare expenditure, rapid urbanization, and the growing need for advanced diagnostic tools in these regions[1][4].

North America and Europe

In North America and Europe, the market is driven by the high demand for PET/CT scans, especially in oncology. The presence of advanced healthcare infrastructure and a higher awareness of the benefits of PET imaging also contribute to the market growth in these regions[4].

Financial Trajectory

Market Value and Growth Rate

The global market for Sodium Fluoride F 18 is part of the broader fluorine-18 market, which was valued over $1.5 billion in 2020. This market is projected to expand at a Compound Annual Growth Rate (CAGR) of 7.5% from 2021 to 2031, reaching a valuation of over $3 billion by 2031[4].

Segmentation and Forecast

The fluorine-18 market, including Sodium Fluoride F 18, is segmented by product (FDG, NaF, others) and end-user (hospitals, diagnostic centers, others). The FDG segment is expected to dominate the market due to its high demand in oncology, but the NaF segment, which includes Sodium Fluoride F 18, is also expected to see significant growth driven by its unique applications in bone imaging[4].

Competitive Landscape

Key Players

The market for Sodium Fluoride F 18 is competitive, with key players including Lantheus Holdings, Inc., Siemens Healthineers, Advanced Accelerator Applications (a Novartis AG Company), GE Healthcare (General Electric Company), and Blue Earth Diagnostics (A Bracco Imaging Company). These companies are investing in research and development to enhance the efficacy and availability of Sodium Fluoride F 18[4].

Pharmacokinetics and Metabolism

Administration and Distribution

Sodium Fluoride F 18 is administered intravenously and rapidly equilibrates within the extracellular fluid space. The fluoride ions are then cleared by bone deposition and excreted via the renal system. This rapid clearance and specific uptake in bone make it an effective diagnostic agent[2][3].

Half-Life and Clearance

The half-life of Fluoride 18F is approximately 109.7 minutes, and it is eliminated primarily through the renal system, with 20% or more cleared within the first two hours after administration[2][3].

Regulatory Framework

FDA Approval and Compliance

Sodium Fluoride F 18 Injection has been approved by the FDA as a bone imaging agent since 1972. It complies with the United States Pharmacopeia (USP) monograph for Sodium Fluoride F 18 Injection and is manufactured following standards for radiopharmaceuticals for PET compounding[2].

Strategic Implications

Market Entry and Expansion

Companies looking to enter or expand in the Sodium Fluoride F 18 market need to consider the growing demand for PET imaging, especially in the Asia Pacific region. Strategic partnerships, investments in R&D, and geographical expansion are key strategies for success in this market[1][4].

Consumer Behavior and Healthcare Trends

Understanding consumer behavior and healthcare trends is crucial. The increasing awareness of the importance of early and precise diagnosis, coupled with the rising healthcare expenditure, presents opportunities for market growth and innovation[1][4].

Key Takeaways

  • Growing Demand: The market for Sodium Fluoride F 18 is driven by the increasing need for precise diagnostic tools, especially in the context of rising cancer rates and other bone-related diseases.
  • Regional Growth: The Asia Pacific region is a significant growth area due to increasing healthcare expenditure and urbanization.
  • Competitive Landscape: Key players are investing in R&D to enhance the efficacy and availability of Sodium Fluoride F 18.
  • Regulatory Compliance: The product must comply with FDA and USP standards.
  • Financial Trajectory: The market is projected to grow at a CAGR of 7.5% from 2021 to 2031, reaching a valuation of over $3 billion by 2031.

FAQs

1. What is Sodium Fluoride F 18 used for?

Sodium Fluoride F 18 is used as a bone imaging agent to define areas of altered osteogenic activity, particularly in the diagnosis of bone-related conditions such as osteomyelitis, trauma, and cancer metastases.

2. What is the half-life of Fluoride 18F?

The half-life of Fluoride 18F is approximately 109.7 minutes[2][3].

3. How is Sodium Fluoride F 18 administered?

Sodium Fluoride F 18 is administered intravenously and rapidly equilibrates within the extracellular fluid space before being cleared by bone deposition and excreted via the renal system[2][3].

4. What regions are driving the growth of the Sodium Fluoride F 18 market?

The Asia Pacific region, particularly countries like India and China, is driving the growth due to increasing healthcare expenditure and rapid urbanization. North America and Europe also contribute significantly due to the high demand for PET/CT scans[1][4].

5. What is the projected market value of the fluorine-18 market by 2031?

The global fluorine-18 market, which includes Sodium Fluoride F 18, is projected to exceed $3 billion by 2031, growing at a CAGR of 7.5% from 2021 to 2031[4].

Cited Sources:

  1. Global Sodium Fluoride Market Projected to Reach US$915.781 Million by 2029 - GlobeNewswire
  2. SODIUM FLUORIDE F 18 INJECTION - Cancer Imaging Program
  3. Fluoride ion F-18: Uses, Interactions, Mechanism of Action - DrugBank
  4. Fluorine-18 Market Insight and Trends 2031 - Transparency Market Research

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.