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Last Updated: December 23, 2024

Fluorescein sodium - Generic Drug Details


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What are the generic drug sources for fluorescein sodium and what is the scope of patent protection?

Fluorescein sodium is the generic ingredient in five branded drugs marketed by Novartis, Long Grove Pharms, Nexus Pharms, and Alcon Labs Inc, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for fluorescein sodium. Four suppliers are listed for this compound.

Summary for fluorescein sodium
US Patents:0
Tradenames:5
Applicants:4
NDAs:4
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 4
Raw Ingredient (Bulk) Api Vendors: 41
Clinical Trials: 44
Patent Applications: 1,431
What excipients (inactive ingredients) are in fluorescein sodium?fluorescein sodium excipients list
DailyMed Link:fluorescein sodium at DailyMed
Recent Clinical Trials for fluorescein sodium

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

SponsorPhase
Stanford UniversityPhase 2
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolEarly Phase 1
Seoul National University Bundang HospitalPhase 4

See all fluorescein sodium clinical trials

Pharmacology for fluorescein sodium
Drug ClassDiagnostic Dye
Mechanism of ActionDyes
Medical Subject Heading (MeSH) Categories for fluorescein sodium
Anatomical Therapeutic Chemical (ATC) Classes for fluorescein sodium

US Patents and Regulatory Information for fluorescein sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alcon Labs Inc FLUORESCITE fluorescein sodium INJECTABLE;INTRAVENOUS 021980-001 Mar 28, 2006 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Long Grove Pharms AK-FLUOR 10% fluorescein sodium INJECTABLE;INTRAVENOUS 022186-001 Aug 8, 2008 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Long Grove Pharms AK-FLUOR 25% fluorescein sodium INJECTABLE;INTRAVENOUS 022186-002 Aug 8, 2008 AP RX Yes Yes ⤷  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

Fluorescein sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluorescein Sodium

Introduction to Fluorescein Sodium

Fluorescein sodium, a water-soluble dye, has been a cornerstone in medical diagnostics, particularly in ophthalmology and neurosurgery, since its synthesis by Adolf von Baeyer in 1871. Its unique fluorescent properties make it an indispensable tool for various medical procedures.

Market Growth and Forecast

The Fluorescein Sodium Injection Market has experienced rapid and substantial growth in recent years, with forecasts indicating continued expansion from 2023 to 2031. This growth is driven by several factors, including increasing demand for diagnostic procedures and advancements in medical technology[1].

  • Market Size and Projections: The market size of Fluorescein Sodium Injection is expected to grow significantly, with forecasts suggesting robust growth rates throughout the forecasted period. The market is categorized based on type (100 mg/1mL, 250 mg/1mL) and application (Hospital, Clinic), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[1].

  • CAGR and Revenue: While specific CAGR figures for the injection market are not provided, the overall trend indicates a strong upward trajectory. For instance, the Fluorescein Sodium Touch Strips Market, a related segment, is witnessing a CAGR of 5.9% during the forecast period 2024-2030, reaching a projected market size of US$ 36.9 million by 2030[4].

Drivers of Market Growth

Several factors are driving the growth of the Fluorescein Sodium market:

  • Increasing Demand for Diagnostic Procedures: The need for accurate and efficient diagnostic tools in ophthalmology and neurosurgery is on the rise, driving the demand for fluorescein sodium[2][5].

  • Advancements in Medical Technology: Improvements in manufacturing processes and the development of new applications for fluorescein sodium, such as in pediatric neurosurgery, are contributing to market growth[5].

  • Regulatory Standards: Tighter specifications and more precise manufacturing routes, as mandated by pharmacopoeial standards, are expected to reduce adverse reactions and enhance the safety profile of fluorescein sodium, further boosting its adoption[2].

Challenges and Restraints

Despite the positive growth trajectory, the market faces several challenges:

  • Drug Shortages: Fluorescein sodium, like many older, lower-cost drugs, is often subject to supply chain disruptions and shortages. These shortages are exacerbated by a lack of incentives for manufacturers to produce less profitable drugs and logistical and regulatory challenges[3].

  • Adverse Reactions and Contamination: Historical issues with impurities, such as dimethylformamide and heavy metal contamination, have led to adverse reactions. However, stricter standards and refined manufacturing processes are expected to mitigate these risks[2].

  • Market Dynamics: The market for fluorescein sodium does not follow typical market responses to scarcity, as drug shortages do not drive increased prices or production. This is due to the lack of financial incentives for manufacturers and the complexities of the pharmaceutical supply chain[3].

Financial Trajectory

The financial trajectory of the Fluorescein Sodium market is characterized by:

  • Revenue Growth: The market is expected to see significant revenue growth, driven by increasing demand and expanding applications. For example, the Fluorescein Sodium Touch Strips Market is projected to grow from US$ 23.8 million in 2023 to US$ 36.9 million by 2030[4].

  • Investment and Manufacturing Costs: Manufacturers are investing in refining their processes to meet stricter pharmacopoeial standards, which may initially increase costs but is expected to lead to long-term benefits in terms of safety and market trust[2].

  • Competitive Landscape: The market is competitive, with several key players such as Madhu Instruments Pvt. Ltd., Care Group Sight Solution, DIOPTIC Pharmaceuticals Inc, and others. This competition drives innovation and quality improvements[4].

Applications and Segments

Fluorescein sodium is used in various applications:

  • Ophthalmology: It is widely used in fluorescein angiography to diagnose and monitor eye diseases such as diabetic retinopathy and macular degeneration[2].

  • Neurosurgery: Recent studies have shown its efficacy in pediatric neurosurgery, particularly in the intraoperative diagnosis of brain tumors[5].

  • Geological Studies: Fluorescein sodium is also used to trace the path of liquids through geological reservoirs[2].

Regional Analysis

The market is segmented geographically into North America, Europe, Asia-Pacific, South America, and Middle-East and Africa. Each region has its own set of drivers and challenges:

  • North America and Europe: These regions are expected to see significant growth due to advanced healthcare infrastructure and high demand for diagnostic procedures[1].

  • Asia-Pacific: This region is anticipated to experience rapid growth driven by increasing healthcare spending and a large patient population[1].

Key Players and Market Share

The market includes several key players:

  • Madhu Instruments Pvt. Ltd.
  • Care Group Sight Solution
  • DIOPTIC Pharmaceuticals Inc
  • Amcon Labs
  • Tianjin Jingming Electronic Materials Co
  • Ophtechnics Unlimited
  • Liaoning Meizilin
  • Entod Research Cell UK Ltd
  • Sidapharm
  • AIESI Hospital Service
  • Optitech Eye Care

These companies are driving innovation and competition in the market[4].

Future Outlook

The future of the Fluorescein Sodium market looks promising:

  • Continued Growth: The market is expected to continue its upward trend, driven by increasing demand and advancements in technology[1].

  • Improved Safety: Stricter manufacturing standards and refined processes are expected to reduce adverse reactions, making fluorescein sodium an even safer diagnostic tool[2].

  • Expanding Applications: New applications, such as in pediatric neurosurgery, are likely to further boost the market[5].

"Given the potential scale of impacts from drug shortages, and the fact that these impacts have continually been underestimated, it is likely that drug shortages will continue to persist absent major changes to the marketplace," - FDA Commissioner Norman Sharpless, M.D.[3]

Key Takeaways

  • The Fluorescein Sodium Injection Market is experiencing rapid growth and is forecasted to continue this trend until 2031.
  • The market is driven by increasing demand for diagnostic procedures and advancements in medical technology.
  • Challenges include drug shortages, adverse reactions due to impurities, and complex market dynamics.
  • The financial trajectory indicates significant revenue growth, with the Fluorescein Sodium Touch Strips Market projected to reach US$ 36.9 million by 2030.
  • Key players are investing in refining manufacturing processes to meet stricter standards.

FAQs

Q: What are the primary applications of fluorescein sodium? A: Fluorescein sodium is primarily used in ophthalmology for fluorescein angiography and in neurosurgery, particularly in pediatric cases. It is also used in geological studies.

Q: Why are drug shortages a significant issue for fluorescein sodium? A: Drug shortages are a problem due to the lack of financial incentives for manufacturers to produce less profitable drugs, logistical challenges, and regulatory complexities.

Q: How are manufacturing processes being improved for fluorescein sodium? A: Manufacturing processes are being refined to meet stricter pharmacopoeial standards, reducing the presence of impurities such as dimethylformamide and heavy metals.

Q: What is the expected market size of the Fluorescein Sodium Touch Strips Market by 2030? A: The Fluorescein Sodium Touch Strips Market is anticipated to reach US$ 36.9 million by 2030.

Q: Who are some of the key players in the Fluorescein Sodium market? A: Key players include Madhu Instruments Pvt. Ltd., Care Group Sight Solution, DIOPTIC Pharmaceuticals Inc, and others.

Sources

  1. Market Research Intellect: Global Fluorescein Sodium Injection Market Size, Trends and Forecasts Report.
  2. OPS Web: Sodium Fluorescein – Colourful Past, Bright Future.
  3. AOA: FDA says fluorescein, ophthalmic meds among drug shortages.
  4. Valuates Reports: Fluorescein Sodium Touch Strips Market.
  5. MDPI: Intraoperative Fluorescein Sodium in Pediatric Neurosurgery.

More… ↓

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