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. Three 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:	2
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

Last updated: July 26, 2026

Market dynamics and financial trajectory for fluorescein sodium and benoxinate hydrochloride ophthalmic drug products

Executive summary

Fluorescein sodium with benoxinate hydrochloride is an ophthalmic combo used for diagnostic visualization (fluorescein) and topical corneal anesthesia (benoxinate). Market demand is driven by routine eye-care procedures and acute care needs, while pricing and unit growth are constrained by (1) small dosing volumes per patient, (2) narrow formulation differentiation, (3) periodic generic entry risk for both actives and associated dosage forms, and (4) procurement-led contracting in hospital and ambulatory surgery settings. Financial outcomes track procedure volumes and payer procurement pricing more than innovation cycles, with steady-to-moderate revenue volatility and typically limited patent-driven growth unless a specific product strength, container system, or formulation receives enforceable exclusivity.

What are the key market drivers for fluorescein sodium + benoxinate hydrochloride ophthalmic use?

Demand is anchored to clinical workflows in optometry, ophthalmology, emergency and urgent care, and ambulatory surgery centers.

Which procedures drive usage?

The typical procedure-linked demand chain is:

• Corneal staining and fluorescein imaging (scratch/abrasion assessment, ocular surface evaluation, foreign body evaluation)
• Slit-lamp examination adjuncts for epithelial integrity and tear film evaluation
• Topical anesthesia need before instillation of staining agents or examination steps in symptomatic patients

Benoxinate hydrochloride is generally used as the “bridge” that improves tolerability for examination and manipulation.

What shifts volume up or down?

Primary volume movers:

• ED/urgent-care presentations for eye pain, suspected corneal abrasions, and foreign bodies
• Elective ophthalmology visit throughput and scheduling patterns
• Pediatric and contact-lens-related presentations (higher clinician use of topical anesthesia to reduce discomfort)
• Seasonality: eye irritation and trauma presentations often track weather and activity patterns

Primary pricing/procurement movers:

• Hospital formulary decisions and group purchasing organization (GPO) contracting
• Conversion from brand to generic for either active or the combination, when available through tenders
• Rebate and wholesaler inventory dynamics after shortages or supply resets

How does the regulated product context affect commercial dynamics?

Both actives are established ophthalmic compounds, so regulatory differentiation tends to be narrow: label indications, strength, dosing instructions, and sterility/preservation details are the commercial levers rather than new efficacy claims. That structure makes the market sensitive to:

• Generic labeling parity
• Substitution rules and pharmacy policy
• Containment by contract pricing in institutional channels

Who buys fluorescein sodium + benoxinate hydrochloride and how does channel mix affect revenue?

Revenue is shaped by two main demand channels: institutional and outpatient.

Institutional procurement: the biggest pricing determinant

Hospital systems and ambulatory surgery centers purchase through:

• Formal group purchasing contracts
• Pharmacy and therapeutics committee selections
• Emergency department stocking and ophthalmology consult workflows

Institutional customers:

• prioritize acquisition cost and stock reliability
• penalize product shortages and variable lead times
• switch products when contract pricing changes even if clinical performance is similar

Net effect: institutional channel mix suppresses margin expansion and increases revenue stability only when continuity of supply is maintained.

Outpatient and office practice: volume-driven but price-sensitive

Independent ophthalmology practices and optometry groups buy through:

• specialty distributors and wholesalers
• occasional direct-to-account purchases
• patient-level billing when compounded or dispensed through outpatient pharmacy depends on local practice

Outpatient customers:

• care about ease of use, packaging, and patient tolerance
• react to brand preferences if perceived as “less stingy,” but they often accept generics if labeling matches

Net effect: outpatient tends to be more volume-dynamic and less contract-anchored than hospital channel.

How do pricing and reimbursement dynamics work for this ophthalmic combo?

For fluorescein sodium and benoxinate hydrochloride, reimbursement depends on the setting and local billing mechanics rather than broad payer “step therapy” models common in systemic drugs.

What constrains pricing power?

• Small per-patient volumes and low wholesale cost base relative to higher-value ophthalmics
• Limited differentiation across generic equivalents
• Tender competition in institutional markets
• Substitution availability at the pharmacy level

Where can pricing hold up?

Pricing holds up when:

• a single supplier controls stable supply in a given period
• a specific strength or presentation is the contracted default
• product availability offsets tender leverage for competitors

Revenue mechanics that dominate financial trajectory

Revenue typically behaves like:

• unit growth follows case volumes
• price growth tracks contract escalators and wholesaler pricing more than innovation
• gross-to-net is shaped by rebates and chargebacks in institutional and large retail-administered segments (when applicable)

What is the typical financial trajectory for fluorescein sodium + benoxinate hydrochloride products?

Without a specific manufacturer and NDC-level revenue dataset, the financial trajectory is best expressed by commercial behavior patterns common to long-established ophthalmic diagnostic-anesthetic products.

Baseline trajectory pattern

• Mid-single-digit to low-double-digit unit sensitivity to procedure volume
• Price per unit mostly flat to modestly rising in normal supply conditions
• Margin pressure during generic normalization or contract renewals
• Short-term revenue spikes during supply constraints or stockpiling cycles

Volatility sources

• Sterility or manufacturing disruptions
• Temporary backorders affecting “must-stock” institutional supply
• Competitive entry that forces price compression in subsequent tender cycles

How does generic entry risk affect the revenue outlook?

The combination contains two well-established actives that are mature in ophthalmic use. Generic entry risk manifests through:

• generic versions of individual components in the same dosage form and strengths
• approved combination or interchangeability that substitutes at procurement

What does “generic pressure” usually look like?

Revenue pressure commonly follows:

• contract re-bids with lower unit pricing
• switching to lowest acquisition cost within the allowed formulary
• reduced inventory ordering by hospitals after stable supply returns

Where is generic risk lower?

Generic substitution may be slower when:

• packaging compatibility or storage conditions are mismatched between products
• institutions have established clinical workflow dependence on a specific product presentation
• local formularies require committee approvals for substitution

What patents protect fluorescein sodium + benoxinate hydrochloride and what does that imply for market exclusivity?

For legacy ophthalmic actives, patent estates tend to be:

• narrow or formulation-specific
• hard to monetize at scale unless a product has enforceable method-of-use, formulation, or packaging IP with remaining term

Commercial implication:

• if the market is already genericized, revenue growth will be contract/procurement-driven rather than exclusivity-driven
• if any remaining patents exist, their commercial value is most likely to be tied to specific presentation or manufacturing method rather than broad molecule coverage

What is the Orange Book status of fluorescein sodium and benoxinate hydrochloride?

Orange Book status determines whether the combo product is still under listed drug substance/product patents and whether ANDA generics can be pursued via Paragraph IV.

How to interpret Orange Book listings for business risk

• If no patents are listed with unexpired expiration/expiry windows, Paragraph IV threats are lower.
• If patents are listed, Paragraph IV filings can introduce settlement-driven generic entry timing.

What formulation and delivery system factors change competitiveness?

Even with identical actives, product competitiveness comes from:

• bottle/instillation system compatibility with clinical workflows
• preservative system and tolerability profile
• shelf life and storage temperature tolerances in outpatient and ED stocking
• sterility assurance and manufacturing consistency

Container system and dosing accuracy

Institutional providers often standardize on products with consistent drop size and reliable instillation mechanics to reduce wastage and training burden.

What manufacturing and supply dynamics influence financial results?

Ophthalmic sterile products can see revenue swings from:

• limited capacity at the manufacturing site for sterile ophthalmic preparations
• filtration/sterilization batch constraints
• inspection outcomes that force supply reallocations

Financial impact pattern:

• missed tender fulfillments reduce quarterly revenue
• temporary substitution may shift revenue to competitors or generics
• backorder disruptions can increase gross-to-net if chargebacks and reships occur

What is the competitive landscape for fluorescein sodium + benoxinate hydrochloride?

Competition is typically defined by:

• approved generic equivalents for the same strengths and dosage form
• contract-specific preferred products in hospital formularies
• distribution reach through wholesalers and specialty distributors

Competitive behaviors that matter commercially

• price resets during formulary cycles
• acquisition cost targeting by generics
• inventory continuity as a bidding differentiator
• co-marketing or sales coverage where tender cycles favor established supplier relationships

How do fluorescein sodium + benoxinate hydrochloride compare with alternatives in corneal staining and topical anesthesia?

Alternatives that affect demand substitution:

• topical anesthetics used instead of benoxinate (other ester or amide local anesthetics depending on practice patterns)
• different staining agents or combination products if available in certain markets
• varying practice patterns between optometry and ophthalmology that influence anesthetic choice

Business implication:

• substitution risk exists if benoxinate use declines in favor of other anesthetics or if protocols standardize another staining approach
• however, fluorescein remains a core diagnostic marker, so complete demand replacement is less likely than partial anesthetic substitution

Key revenue exposure scenarios for manufacturers and distributors

Financial planning should model three scenarios tied to procurement and supply.

Scenario A: stable tender pricing, moderate volume growth

• unit sales track procedure volume
• pricing flat to modestly up
• revenue grows with limited margin expansion

Scenario B: generic/contract switch drives price compression

• unit volumes may partially offset price cuts
• gross margin declines due to lower net price and higher rebate/contract giveback pressure

Scenario C: supply constraint favors incumbent or contract winner

• short-term revenue spikes from backorder fill allocation
• longer-term revenue can normalize after supply restabilizes

What patent litigation or settlement activity could affect launch timing?

For mature ophthalmic actives, large-scale litigation is less frequent than in branded specialty medicines, but settlement-driven entry timing can still occur if:

• unexpired Orange Book patents exist for a specific product presentation
• Paragraph IV challenges prompt FDA approval stays or court settlements

Commercial implication:

• entry timing can create quarter-level revenue shocks
• once generics enter, competitive pricing pressure typically persists

What FDA and regulatory pathway considerations shape market entry?

Market entry depends on whether applicants can rely on:

• established safety and efficacy through generic development
• bioequivalence requirements appropriate for ophthalmic solutions
• preservative and sterility compliance

Regulatory outcomes that influence business:

• approval delays due to chemistry/manufacturing changes
• labeling differences affecting substitutability
• inspection-driven production bottlenecks that create supply risk

Key Takeaways

• Demand is procedure-linked: corneal staining and exam workflows drive volume, with ED and urgent-care presentations as a meaningful contributor.
• Pricing power is structurally limited by generic substitutability and institutional procurement.
• Revenue trajectory is dominated by unit volume and contract pricing rather than innovation cycles.
• Financial volatility tends to come from supply reliability, tender cycles, and generic entry.
• Patent and Orange Book-driven exclusivity, if present, is most likely presentation-specific and can affect quarter-level entry timing through Paragraph IV and settlement mechanics.

FAQs

1. How quickly do hospitals switch fluorescein sodium/benoxinate ophthalmic products after a lower-cost generic wins a tender?
2. What presentation details (strength, container size, preservative) most influence formulary acceptance for fluorescein sodium and benoxinate hydrochloride?
3. Do shortages of sterile ophthalmic solutions create durable share shifts or only short-term revenue spikes?
4. What is the typical seasonality pattern for ocular surface diagnostic and abrasion-related workflows that use fluorescein staining?
5. Which downstream substitutions are most common: switching staining agents or switching topical anesthetics used before fluorescein exam?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. FDA. Application Integrity Policy and generic drug review framework resources. U.S. Food and Drug Administration. https://www.fda.gov/