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

Constraining patent/regulatory exclusivity:

10,842,872

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
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
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	10,293,047		Y

International Patents for BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM

Country	Patent Number	Title	Estimated Expiration
Canada	3082603
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)
Canada	3082603	COMPOSITIONS DE FLUORESCEINE ET DE BENOXINATE (FLUORESCEIN AND BENOXINATE COMPOSITIONS)
World Intellectual Property Organization (WIPO)	2019099739

BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Benoxinate Hydrochloride and Fluorescein Sodium

Introduction

Benoxinate hydrochloride and fluorescein sodium are key components of a widely used ophthalmic solution, essential for various eye procedures. This combination product has been a staple in ophthalmology for decades, and its market dynamics are influenced by several factors.

Historical Context

Benoxinate hydrochloride, a topical anesthetic, was first permitted in 1953, while fluorescein sodium, a disclosing agent, has been used in combination with benoxinate hydrochloride since the 1960s. Until recently, these formulations were marketed without FDA approval, but in December 2017, Altaire Pharmaceuticals Inc. received FDA approval for Altafluor Benox, a combination product containing fluorescein sodium 0.25% and benoxinate hydrochloride 0.4%[1].

Market Size and Growth

The global market for fluorescein sodium ophthalmic strips, which often include benoxinate hydrochloride, is projected to grow significantly. From 2023 to 2029, the market is expected to increase from $23.79 million to $33.66 million, with a Compound Annual Growth Rate (CAGR) of 5.95%[2].

Key Players

The market is dominated by several key players, including Biotech Healthcare Group, Madhu Instruments Pvt. Ltd., Care Group Sight Solution, DIOPTIC Pharmaceuticals Inc, and Amcon Labs. In 2022, the top five vendors accounted for approximately 67.26% of the revenue, indicating a concentrated market with significant competition among major players[2].

Regional Market Analysis

The market is segmented by region, with North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa being key areas of focus. Each region has its own market dynamics, driven by local healthcare infrastructure, regulatory environments, and patient needs. For instance, the Asia-Pacific region is expected to see significant growth due to increasing healthcare expenditures and a growing population[2].

Application and Usage

Fluorescein sodium and benoxinate hydrochloride ophthalmic solution is indicated for ophthalmic procedures in both adult and pediatric patients. It is used for procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic, such as applanation tonometry, tear fluid dynamics evaluation, and short conjunctival and corneal procedures[3][4].

Dosage and Administration

The solution is administered topically, with 1 to 2 drops instilled in the eye as needed to achieve adequate anesthesia. The formulation contains fluorescein sodium 2.6 mg/mL (0.3%) and benoxinate hydrochloride 4.4 mg/mL (0.4%)[3][4].

Adverse Reactions and Safety

Common adverse reactions include ocular hyperemia, burning, stinging, eye irritation, blurred vision, and punctate keratitis. The product is contraindicated in patients with known hypersensitivity to any component of the solution. There are limited data on its use in pregnant women and its presence in human milk, which necessitates careful consideration in these patient groups[3][4].

Competitive Landscape

The competitive landscape is characterized by a few dominant players and a range of smaller manufacturers. The market is driven by innovation in formulation, packaging, and distribution. Companies are focusing on improving product stability, shelf life, and patient compliance to gain market share[2].

Market Drivers and Restrictive Factors

Key drivers include the increasing demand for ophthalmic procedures, advancements in diagnostic technologies, and growing healthcare expenditures. However, restrictive factors such as regulatory hurdles, competition from generic products, and potential side effects can impact market growth[2].

Financial Performance

The financial performance of the market is robust, with a projected growth rate of 5.95% CAGR from 2023 to 2029. This growth is driven by increasing sales revenue and market share of key players. The market size is expected to expand from $23.79 million in 2023 to $33.66 million by 2029, indicating a significant financial trajectory[2].

Future Prospects

The future prospects of the benoxinate hydrochloride and fluorescein sodium market look promising, driven by the increasing need for diagnostic and therapeutic ophthalmic solutions. As healthcare systems evolve and populations age, the demand for these products is likely to increase, providing opportunities for market growth and expansion.

Key Takeaways

• The global market for fluorescein sodium ophthalmic strips, including benoxinate hydrochloride, is growing at a CAGR of 5.95% from 2023 to 2029.
• Key players dominate the market, with significant competition among them.
• The solution is widely used for various ophthalmic procedures and has a well-established safety profile.
• Market growth is driven by increasing healthcare expenditures and advancements in diagnostic technologies.
• Regulatory and competitive factors can impact market dynamics.

FAQs

Q: What is the primary use of fluorescein sodium and benoxinate hydrochloride ophthalmic solution? A: The solution is used for ophthalmic procedures in adult and pediatric patients, requiring a disclosing agent in combination with a topical ophthalmic anesthetic.

Q: Who are the major players in the global fluorescein sodium ophthalmic strip market? A: Major players include Biotech Healthcare Group, Madhu Instruments Pvt. Ltd., Care Group Sight Solution, DIOPTIC Pharmaceuticals Inc, and Amcon Labs.

Q: What is the projected market size for fluorescein sodium ophthalmic strips by 2029? A: The market is projected to grow to $33.66 million by 2029.

Q: What are the common adverse reactions associated with fluorescein sodium and benoxinate hydrochloride ophthalmic solution? A: Common adverse reactions include ocular hyperemia, burning, stinging, eye irritation, blurred vision, and punctate keratitis.

Q: Is the use of fluorescein sodium and benoxinate hydrochloride ophthalmic solution safe in pediatric patients? A: Yes, the safety and effectiveness of the solution have been established for pediatric patients through adequate and well-controlled studies[3][4].

Cited Sources:

1. FDA, Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% CDER Cross Discipline Team Leader Review Template, October 10, 2017.
2. QYResearch, Global Fluorescein Sodium Ophthalmic Strip Market Insights, November 16, 2023.
3. DailyMed, Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4%, Oceanside Pharmaceuticals.
4. DailyMed, Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4%, Bausch & Lomb Incorporated.