FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE Drug Patent Profile

Which patents cover Fluorescein Sodium And Benoxinate Hydrochloride, and when can generic versions of Fluorescein Sodium And Benoxinate Hydrochloride launch?

Fluorescein Sodium And Benoxinate Hydrochloride is a drug marketed by Bausch Lomb Ireland and is included in one NDA. There are three patents protecting this drug.

This drug has four patent family members in four countries.

The generic ingredient in FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE is benoxinate hydrochloride; fluorescein sodium. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the benoxinate hydrochloride; fluorescein sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Fluorescein Sodium And Benoxinate Hydrochloride

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 15, 2037. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

International Patents:	4
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Clinical Trials:	1
What excipients (inactive ingredients) are in FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE?	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE excipients list
DailyMed Link:	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

10,842,872

NDA:

211039

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 FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

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

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

See all FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE clinical trials

Pharmacology for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

Drug Class	Diagnostic Dye
Mechanism of Action	Dyes

US Patents and Regulatory Information for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE is protected by three US patents.

This potential generic entry date is based on patent 10,842,872.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch Lomb Ireland	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	benoxinate hydrochloride; fluorescein sodium	SOLUTION/DROPS;OPHTHALMIC	211039-001	Mar 9, 2020		RX	Yes	Yes	10,842,872
Bausch Lomb Ireland	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	benoxinate hydrochloride; fluorescein sodium	SOLUTION/DROPS;OPHTHALMIC	211039-001	Mar 9, 2020		RX	Yes	Yes	10,632,197		Y
Bausch Lomb Ireland	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	benoxinate hydrochloride; fluorescein sodium	SOLUTION/DROPS;OPHTHALMIC	211039-001	Mar 9, 2020		RX	Yes	Yes	10,293,047		Y

International Patents for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

When does loss-of-exclusivity occur for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

China

European Patent Office

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE around the world.

Country	Patent Number	Title	Estimated Expiration
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)

Market Dynamics and Financial Trajectory for Fluorescein Sodium and Benoxinate Hydrochloride

Last updated: July 27, 2025

Introduction

Fluorescein sodium and benoxinate hydrochloride are widely used ophthalmic agents with significant roles in diagnostic and surgical ophthalmology. Fluorescein sodium, a fluorescent dye, primarily aids in corneal and retinal examinations, whereas benoxinate hydrochloride functions as a local anesthetic facilitating various ophthalmic procedures. The evolving landscape of ophthalmic diagnostics and therapeutics directly influences the market trajectories for these compounds. This analysis explores key market dynamics and the financial outlook for fluorescein sodium and benoxinate hydrochloride, considering factors like demand drivers, regulatory environments, competitive forces, and innovation trends.

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Market Overview and Industry Context

The global ophthalmic diagnostic and therapeutic market, valued at approximately USD 12.8 billion in 2022, is projected to expand at a compound annual growth rate (CAGR) of 5.8% through 2030 [1]. This growth trajectory is underpinned by increasing prevalence of ocular diseases, technological advances in diagnostic imaging, and expanding surgical interventions. Fluorescein sodium and benoxinate hydrochloride occupy integral niches within this larger market, serving both diagnostic imaging and anesthesia needs.

Fluorescein Sodium: Existing primarily in ophthalmology, fluorescein sodium is essential for fluorescein angiography, corneal staining, and retina examinations. The demand reflects rising incidences of diabetic retinopathy, age-related macular degeneration, and rising laser-based diagnostic procedures. The global fluorescein market alone is valued at approximately USD 485 million as of 2022 [2], with optimistic growth projections.

Benoxinate Hydrochloride: As a topical anesthetic, it is predominantly used during eye surgeries such as cataract extraction, tonometry, and diagnostic procedures like slit-lamp exams. Though less expansive than fluorescein, the anesthetic’s market benefits from procedural growth, especially in emerging markets with expanding ophthalmic surgical volume.

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Market Drivers

1. Rising Prevalence of Ocular Diseases

Globally, ocular degenerative diseases such as diabetic retinopathy, glaucoma, and age-related macular degeneration drive demand for ophthalmic diagnostics utilizing fluorescein sodium. Similarly, surgical interventions are augmenting the need for local anesthetics like benoxinate hydrochloride, especially in aging populations.

2. Technological Advancements in Diagnostics and Surgery

Innovations such as ultra-widefield fluorescein angiography, optical coherence tomography (OCT), and laser-assisted procedures amplify reliance on fluorescein dyes. Enhanced ocular imaging improves detection accuracy, boosting product utilization. Concurrently, advances in minimally invasive surgery increase the volume of procedures requiring local anesthesia.

3. Growing Healthcare Infrastructure and Accessibility

Emerging markets exhibit expanding ophthalmology departments and increasing procedural volumes, notably due to rising health awareness and diabetes prevalence. These developments expand the customer base for both fluorescein sodium and anesthetics.

4. Regulatory Approvals and Patent Landscapes

Regulatory environments influence market entries and product innovation. USFDA approvals and EMA clearances facilitate market penetration. The expiration of patents on certain formulations often leads to price competition but also encourages generics, which can expand accessibility.

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Market Challenges and Constraints

1. Competitive Market and Price Erosion

The presence of multiple generic manufacturers exerts downward pricing pressure, constraining profit margins. The commoditized nature of dyes and anesthetics limits differentiation possibilities.

2. Stringent Regulatory and Safety Concerns

Regulatory agencies enforce rigorous safety and efficacy standards. Reports of adverse reactions, such as allergic responses to fluorescein, can lead to product recalls or restrictions, affecting market stability.

3. Supply Chain and Raw Material Volatility

Fluorescein and benoxinate production depend on specific chemical precursors susceptible to geopolitical risks, price fluctuations, and availability issues, impacting manufacturing costs.

4. Competition from Alternative Imaging Techniques

Emerging imaging modalities with reduced or no reliance on dyes, like OCT angiography, may diminish fluorescein’s role, impacting long-term demand.

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Financial Trajectory and Market Forecast

Revenue Projections

• Fluorescein Sodium: Expected to grow from USD 485 million in 2022 at a CAGR of 5.2% through 2030, driven chiefly by ophthalmic diagnostics expansion [2].

• Benoxinate Hydrochloride: Estimated to experience a CAGR of approximately 4.8%, reaching USD 75 million by 2030. Growth is contingent on increased surgical volumes, especially in developing countries.

Regional Market Trends

• North America: Dominates due to advanced healthcare infrastructure and high diagnostic and surgical volumes. Market value is projected at USD 175 million for fluorescein in 2022 with steady growth [3].

• Europe: Similar growth dynamics, with regulatory consistency and technological adoption driving demand.

• Asia-Pacific: Fastest growth rate (~6.8%), driven by expanding ophthalmology clinics, increasing disease prevalence, and rising healthcare investments, particularly in China and India.

Profitability Outlook

Margins remain modest owing to pricing pressures from generics. Companies investing in formulation innovation, such as longer shelf-life or lower side-effect profiles, could command premium pricing. Integrating diagnostic imaging partnerships and surgical device collaborations could diversify revenue streams.

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Innovation and Product Development Impact

The development of next-generation fluorescein formulations—such as liposomal encapsulations or conjugates—aims to enhance fluorescence intensity, reduce adverse reactions, and extend shelf life. Such innovations could command increased pricing power and market share.

Similarly, formulations of benoxinate hydrochloride with combined agents could provide multi-therapeutic applications, further expanding market potential.

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Regulatory and Market Entry Considerations

Nations with emerging ophthalmic markets, including China and India, offer lucrative opportunities. Local regulatory approval, effective distribution channels, and partnerships with regional players are critical. Transparency in safety data and adherence to international standards promote faster market access.

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Key Market Players and Competitive Landscape

Major players include Novartis, Alcon, Allergan, and TEVA Pharmaceuticals, often operating through generic manufacturing and branded formulations. Market entry strategies comprise product launches, licensing agreements, and strategic acquisitions.

The market trend suggests consolidation, with key players investing in pipeline diversification and technology enhancements to maintain competitiveness.

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Conclusion

The market for fluorescein sodium and benoxinate hydrochloride is poised for steady growth over the next decade, driven by increasing ophthalmic diagnostic and surgical needs globally. While challenges such as pricing pressures and regulatory hurdles persist, innovation, regional expansion, and strategic alliances will underpin sustained financial trajectories. Market participants should emphasize product differentiation, regulatory compliance, and accessibility enhancements to capitalize on emerging opportunities.

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Key Takeaways

• The combined ophthalmic diagnostic and surgical sector fuels demand for fluorescein sodium and benoxinate hydrochloride, with expected CAGR exceeding 5% until 2030.
• Technological innovations in imaging and minimally invasive surgery will be critical in maintaining and growing market share.
• Emerging markets present significant growth avenues, provided companies navigate regulatory landscapes effectively.
• Price erosion due to generics necessitates innovation for margin preservation.
• Strategic collaborations and product line extensions are essential for competitive advantage in this commoditized market.

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FAQs

1. What are the primary medical applications of fluorescein sodium?
Fluorescein sodium is predominantly used in ophthalmic procedures such as fluorescein angiography, corneal staining, and retinal examinations to visualize ocular blood vessels and surface integrity.

2. How does benoxinate hydrochloride differ from other ophthalmic anesthetics?
Benoxinate hydrochloride provides rapid onset and short duration of anesthesia with minimal systemic absorption, making it ideal for diagnostic procedures like tonometry and slit-lamp examinations.

3. Are there safety concerns associated with these compounds?
Yes, adverse reactions such as allergic responses or toxicity are rare but documented. Proper formulation, dosing, and screening mitigate these risks, and regulatory agencies monitor safety profiles continually.

4. How might technological advances impact the demand for fluorescein sodium?
Emerging imaging technologies like OCT angiography reduce reliance on dyes, potentially affecting long-term demand. However, fluorescein remains vital for certain diagnostics, ensuring continued relevance.

5. What strategies should market entrants pursue?
Successful strategies include focusing on regulatory compliance, product innovation to improve safety and efficacy, regional partnerships, and differentiation through formulation advancements.

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References

[1] MarketsandMarkets. (2022). Ophthalmic Diagnostics Market & Instruments.
[2] Grand View Research. (2022). Fluorescein Market Size, Share & Trends.
[3] Persistence Market Research. (2022). Ophthalmic Diagnostics Market Analysis.