Benoxinate hydrochloride; fluorescein sodium - Generic Drug Details

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

Benoxinate hydrochloride; fluorescein sodium is the generic ingredient in two branded drugs marketed by Altaire Pharms Inc and Bausch Lomb Ireland, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Benoxinate hydrochloride; fluorescein sodium has four patent family members in four countries.

Four suppliers are listed for this compound.

Summary for benoxinate hydrochloride; fluorescein sodium

International Patents:	4
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	4
Clinical Trials:	1
DailyMed Link:	benoxinate hydrochloride; fluorescein sodium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for benoxinate hydrochloride; fluorescein sodium

Dosage:

SOLUTION/DROPS;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for benoxinate hydrochloride; fluorescein sodium

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

Sponsor	Phase
Centre de recherche du Centre hospitalier universitaire de Sherbrooke	N/A

See all benoxinate hydrochloride; fluorescein sodium clinical trials

Pharmacology for benoxinate hydrochloride; fluorescein sodium

Drug Class	Diagnostic Dye
Mechanism of Action	Dyes

Anatomical Therapeutic Chemical (ATC) Classes for benoxinate hydrochloride; fluorescein sodium

S01JA	Colouring agents
S01J	DIAGNOSTIC AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for benoxinate hydrochloride; fluorescein sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Altaire Pharms Inc	ALTAFLUOR BENOX	benoxinate hydrochloride; fluorescein sodium	SOLUTION/DROPS;OPHTHALMIC	208582-001	Dec 14, 2017		RX	Yes	Yes
Bausch Lomb Ireland	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	benoxinate hydrochloride; fluorescein sodium	SOLUTION/DROPS;OPHTHALMIC	211039-001	Mar 9, 2020		RX	Yes	Yes			Y
Bausch Lomb Ireland	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	benoxinate hydrochloride; fluorescein sodium	SOLUTION/DROPS;OPHTHALMIC	211039-001	Mar 9, 2020		RX	Yes	Yes
Bausch Lomb Ireland	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	benoxinate hydrochloride; fluorescein sodium	SOLUTION/DROPS;OPHTHALMIC	211039-001	Mar 9, 2020		RX	Yes	Yes			Y

International Patents for benoxinate hydrochloride; fluorescein sodium

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3710069
Canada	3082603
Canada	3082603	COMPOSITIONS DE FLUORESCEINE ET DE BENOXINATE (FLUORESCEIN AND BENOXINATE COMPOSITIONS)
China	111565761	荧光素和丁氧普鲁卡因组合物 (FLUORESCEIN AND BENOXINATE COMPOSITIONS)
European Patent Office	3710069	COMPOSITIONS DE FLUORESCÉINE ET DE BÉNOXINATE (FLUORESCEIN AND BENOXINATE COMPOSITIONS)
World Intellectual Property Organization (WIPO)	2019099739
Canada	3082603	COMPOSITIONS DE FLUORESCEINE ET DE BENOXINATE (FLUORESCEIN AND BENOXINATE COMPOSITIONS)

Market Dynamics and Financial Trajectory for BENOXINATE HYDROCHLORIDE and FLUORESCEIN SODIUM

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape continually evolves, driven by advances in medical technology, regulatory changes, and emerging therapeutic needs. Among the myriad of drugs navigating this complex environment, Benoxinate Hydrochloride and Fluorescein Sodium occupy specialized niches—primarily within ophthalmology and diagnostic imaging. This article explores the market dynamics and financial trajectories associated with these two compounds, highlighting factors that influence their adoption, regulatory status, competitive landscape, and economic prospects.

Benoxinate Hydrochloride: Market Overview

Therapeutic Use and Market Position

Benoxinate Hydrochloride is a local anesthetic predominantly used in ophthalmic procedures. It is often combined with other agents to facilitate eye surgeries, including tonometry, fluorescein angiography, and various diagnostic tests [1]. Its transient anesthetic effect enhances patient comfort and procedural accuracy.

Market Drivers

• Growing prevalence of ocular diseases: Age-related macular degeneration, glaucoma, and diabetic retinopathy have increased demand for diagnostic and surgical procedures, bolstering the use of Benoxinate.
• Advancements in ophthalmic diagnostics: The expansion of minimally invasive diagnostic techniques necessitates reliable topical anesthetics.
• Regulatory approvals: Benoxinate Hydrochloride enjoys approval in multiple regional markets, including the U.S., Europe, and Asia, which bolsters global access.

Market Challenges

• Regulatory hurdles: Stringent approval pathways and local regulation variations can delay market entry.
• Competition: Several other local anesthetics, such as proparacaine and tetracaine, vie for market share.
• Generic erosion: Patent expirations lead to increased generic competition, affecting pricing and margins.

Financial Trajectory

The global ophthalmic anesthetic market, where Benoxinate operates, is projected to grow at a compound annual growth rate (CAGR) of approximately 5-7% through 2030 [2]. Margins are under pressure from generic entrants, yet the drug benefits from consistent procedural demand and expanding ophthalmic practices.

Major players such as Akorn and Bausch + Lomb manufacture Benoxinate formulations, indicating a mature but stable market. Future financial prospects hinge on regional regulatory extensions, formulation innovations (e.g., sustained-release formulations), and integration into combination products.

Fluorescein Sodium: Market Dynamics

Application and Market Significance

Fluorescein Sodium is a vital diagnostic dye used in ophthalmology, cardiology, and systemic disease screening. Its primary application involves retinal angiography, which offers detailed visualization of retinal vasculature—crucial for diagnosing diabetic retinopathy, macular degeneration, and other ocular pathologies [3].

Market Drivers

• Rising burden of ocular diseases: Increased diabetic patient populations foster higher demand for fluorescein angiography.
• Innovation in imaging modalities: Advances in fundus photography and optical coherence tomography (OCT) improve diagnostic accuracy, increasing fluorescein use.
• Regulatory approvals and quality standards: As a class 3 medical device, fluorescein's regulatory landscape remains stable, with ongoing updates ensuring safety and efficacy.

Market Challenges

• Supply chain dependency: Reliance on bulk manufacturing in limited geographic regions can disrupt availability.
• Regulatory variability: Standards differ across jurisdictions, impacting exportability and manufacturing practices.
• Alternatives and innovation: The development of alternative dyes (e.g., indocyanine green) and non-invasive imaging techniques pose a competitive threat.

Financial Trajectory

The global fluorescein market is anticipated to expand at a CAGR of roughly 4-6% over the next decade, driven by increasing ophthalmology procedures and innovations in retinal imaging [4].

Major suppliers, including Akorn and Novartis, maintain dominant positions, aided by established distribution channels. Pricing pressures from generics and biosimilar-like formulations influence margins. Investment in quality assurance and scalable manufacturing remains critical.

Market Dynamics: Interplay and Influences

Regulatory Environment

Both drugs are subject to stringent regulations. For Benoxinate, regulatory approval processes focus on safety profiles and preclinical data; for fluorescein, compliance involves sterility, purity, and stability. Harmonization efforts under agencies like the FDA and EMA influence market access.

Competitive Landscape

Generic proliferation and regional manufacturers broaden the supply base but intensify price competition. Differentiation through formulation improvements or proprietary delivery systems offers growth opportunities.

Technological Advances

Innovations such as sustained-release formulations of Benoxinate and digital angiography systems augment the practical utility of these drugs. Such developments can influence market share and revenue streams.

Economic and Demographic Factors

Aging populations and increasing chronic disease prevalence globally translate into sustained demand, reinforcing the financial trajectory for both drugs.

Financial Outlook and Investment Implications

While both Benoxinate Hydrochloride and Fluorescein Sodium display stable growth trajectories, the key to capturing value lies in navigating regulatory hurdles efficiently, fostering manufacturing agility, and innovating within their respective niches. Market entrants with cost-effective formulations or enhanced delivery systems stand to gain a significant competitive advantage.

In particular, emerging markets offer accessible growth, propelled by expanding healthcare infrastructure and ophthalmology services. Consequently, global revenues for these drugs are expected to expand, with regional specifics influencing profit margins and investment returns.

Conclusion

Benoxinate Hydrochloride and Fluorescein Sodium remain pivotal in ophthalmologic diagnostics and interventions. Their market dynamics are shaped by aging demographics, technological progress, and regulatory factors. While challenges such as generic competition and regulatory variability exist, ongoing innovation and strategic regional expansion underpin their positive financial trajectories.

Stakeholders should focus on:

• Regulatory strategy optimization
• Innovation in formulation and delivery methods
• Enhancing supply chain resilience
• Expanding into emerging markets
• Staying abreast of technological advances in ophthalmic diagnostics

Key Takeaways

• Market stability stems from steady procedural demand in ophthalmology, reinforced by demographic trends.
• Competitive pressures necessitate innovation and efficient manufacturing to sustain profitability.
• Regulatory navigation remains critical; regional differences influence market access and revenue potential.
• Emerging markets present lucrative opportunities owing to expanding healthcare infrastructure.
• Technological integration with imaging and diagnostic tools can elevate product value and market positioning.

FAQs

1. What are the primary therapeutic uses of Benoxinate Hydrochloride?
Benoxinate Hydrochloride functions as a topical anesthetic used in ophthalmic procedures to reduce discomfort and improve procedural accuracy, especially during diagnostic tests like tonometry and fluorescein angiography [1].

2. How does the regulatory landscape affect the market for Fluorescein Sodium?
Regulations ensure product safety and quality, influencing manufacturing standards and exportability. Variations across regions require manufacturers to adapt formulations and adhere to local standards, affecting market penetration and revenue streams [3].

3. What competitive strategies can companies employ for these drugs?
Strategies include developing sustained-release formulations, expanding regional manufacturing and distribution, obtaining regulatory extensions, and integrating into combination therapies to differentiate products and improve margins.

4. How is technological innovation influencing the market for these drugs?
Advances in imaging technologies, such as high-resolution retinal scanners and OCT, increase demand for diagnostic dyes like fluorescein. Similarly, novel formulations of anesthetics improve patient comfort and procedural efficiency.

5. What are the prospects for market growth in emerging countries?
Emerging markets offer significant growth potential due to rising ophthalmologic disease prevalence, expanding healthcare access, and increasing investments in medical infrastructure, making them attractive regions for market expansion.

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References

[1] Ophthalmic Anesthetics Market Analysis. (2022). Market Research Future.
[2] Global Ophthalmic Anesthetics Market Report. (2022). Grand View Research.
[3] Fluorescein Market Outlook. (2021). MarketsandMarkets.
[4] Retinal Imaging and Diagnostic Dyes. (2022). Allied Market Research.