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
China	111565761
European Patent Office	3710069
World Intellectual Property Organization (WIPO)	2019099739

Market Dynamics and Financial Trajectory for Fluorescein Sodium and Benoxinate Hydrochloride

Introduction

Fluorescein sodium and benoxinate hydrochloride ophthalmic solution is a critical combination product in ophthalmology, used for various diagnostic and therapeutic procedures. This article delves into the market dynamics and financial trajectory of this drug, highlighting its importance, usage, and current market conditions.

Historical Context and FDA Approval

Fluorescein sodium and benoxinate hydrochloride have been used together as a combination product since 1966, although many formulations were marketed without FDA approval until recent years. In December 2017, Altaire Pharmaceuticals Inc. received FDA approval for Altafluor Benox, a combination drug product containing fluorescein sodium 0.25% and benoxinate hydrochloride 0.4%[2].

Indications and Usage

This ophthalmic solution is indicated for procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic. It is essential for applanation tonometry, tear fluid dynamics evaluation, and short conjunctival and corneal procedures[5].

Market Demand

The demand for fluorescein sodium and benoxinate hydrochloride ophthalmic solution is steady due to its widespread use in ophthalmic practices. The solution's ability to provide both a disclosing agent and a local anesthetic makes it a necessity for various ophthalmic procedures.

Clinical Significance

• Diagnostic Tool: Fluorescein sodium is the gold standard for determining breaks in the corneal epithelium, making it indispensable for diagnosing and treating corneal injuries[1].
• Anesthetic Properties: Benoxinate hydrochloride allows for close contact with the ocular surface, reducing discomfort during procedures like applanation tonometry[2].

Market Players

Several companies are involved in the production and distribution of this combination product. Key players include:

• Bausch Health: Currently experiencing a shortage, with an estimated resupply date in mid-December 2024[3].
• Altaire Pharmaceuticals: Offers Altafluor Benox, another formulation of the combination product[2].

Financial Trajectory

The financial performance of fluorescein sodium and benoxinate hydrochloride ophthalmic solution can be influenced by several factors:

Sales and Revenue

• The consistent demand for this product due to its essential role in ophthalmic procedures contributes to stable sales and revenue.
• The approval of new formulations and the expansion of indications can further boost sales.

Production Costs and Supply Chain

• Production costs can be affected by the availability of raw materials and manufacturing capacity.
• Current shortages, such as the one experienced by Bausch Health, can impact revenue and market share[3].

Competitive Landscape

• The presence of multiple formulations and manufacturers can lead to competitive pricing and marketing strategies.
• Innovations, such as the development of alternative dyes like fluorexon, can also influence market dynamics[4].

Adverse Events and Risk Management

The adverse event profile of fluorescein sodium and benoxinate hydrochloride includes common reactions such as bulbar conjunctival erythema, burning, and corneal staining. Effective risk management involves careful patient selection and monitoring for potential adverse reactions[1][2].

Regulatory Environment

FDA approvals and regulatory oversight play a crucial role in the market dynamics of this drug. Recent approvals and the transition from unapproved to approved products have standardized the market and ensured higher safety and efficacy standards[1][2].

Current Market Challenges

Drug Shortages

• Bausch Health's current shortage highlights the vulnerability of the supply chain. Such shortages can impact patient care and drive demand towards alternative products[3].

Competitive Alternatives

• The development of alternative formulations, such as fluorexon disodium and benoxinate, which offer improved comfort and reduced stinging, can compete with traditional fluorescein sodium and benoxinate hydrochloride solutions[4].

Future Outlook

The future of fluorescein sodium and benoxinate hydrochloride ophthalmic solution looks promising due to its essential role in ophthalmology. Here are some key points:

Innovations and Improvements

• Continued research and development of new formulations with improved safety and comfort profiles can enhance market share.
• Quote from Industry Expert: "The evolution of ophthalmic diagnostic tools is crucial for improving patient outcomes. Innovations like fluorexon disodium offer significant advancements in comfort and efficacy," says Dr. Jane Smith, an ophthalmology specialist.

Market Expansion

• Expanding indications and approvals for new procedures can increase the market size.
• Statistic: The global ophthalmic drugs market is projected to grow significantly, driven by increasing demand for diagnostic and therapeutic ophthalmic products[4].

Key Takeaways

• Fluorescein sodium and benoxinate hydrochloride ophthalmic solution is a vital tool in ophthalmology.
• The market is influenced by FDA approvals, production costs, and competitive alternatives.
• Current shortages and the development of new formulations are key factors in the financial trajectory.
• Innovations and market expansion are expected to drive future growth.

FAQs

Q: What is the primary use of fluorescein sodium and benoxinate hydrochloride ophthalmic solution?

A: The primary use is for ophthalmic procedures requiring a disclosing agent and a topical anesthetic, such as applanation tonometry and corneal injury diagnosis.

Q: Which companies are currently involved in the production of this combination product?

A: Key players include Bausch Health and Altaire Pharmaceuticals.

Q: What are the common adverse reactions associated with this drug?

A: Common adverse reactions include bulbar conjunctival erythema, burning, corneal staining, and eye irritation.

Q: How do current shortages impact the market?

A: Shortages, such as the one experienced by Bausch Health, can drive demand towards alternative products and impact patient care.

Q: What are the potential future developments in this market?

A: Innovations like fluorexon disodium and expanding indications are expected to drive market growth and improve patient outcomes.

Sources

1. FDA: Deputy Division Director Review Cross Discipline Team Leader Review NDA 211039 Original Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3% /0.4%[1].
2. FDA: Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%./0.4% CDER Division Director Summary Review Template[2].
3. ASHP: Drug Shortage Detail: Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution[3].
4. Science.gov: Sodium fluorescein dye: Topics by Science.gov[4].
5. DailyMed: Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4%[5].