When will the patents on FLUORESCITE expire, and when will FLUORESCITE go generic?

Sponsor	Phase
Aditya Kaza	Phase 2
National Heart, Lung, and Blood Institute (NHLBI)	Phase 2
Medicor Research Inc.	Phase 1

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Labs Inc	FLUORESCITE	fluorescein sodium	INJECTABLE;INTRAVENOUS	021980-001	Mar 28, 2006	AP	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: September 6, 2026

Fluorescite is Alcon’s fluorescein sodium injection used for diagnostic ophthalmic imaging, primarily fluorescein angiography. Its commercial profile differs from high-value ophthalmology medicines: the active ingredient is old, generic competition exists, and the product has limited patent protection. Revenue is therefore driven by procedure volume, hospital and clinic contracts, supply reliability, vial economics, and manufacturing continuity rather than exclusivity.

Alcon does not publicly report Fluorescite revenue as a separate product line. The company reports results by operating segment and broader product categories, so Fluorescite’s financial trajectory must be assessed through market structure, regulatory status, competitive supply, and the economics of diagnostic ophthalmic procedures rather than disclosed product-level sales.

What is Fluorescite and how is it used?

Fluorescite is fluorescein injection, USP, 10%, containing fluorescein sodium at a concentration of 100 mg/mL. It is administered intravenously to visualize retinal and choroidal circulation during diagnostic angiography. The product is not a therapeutic ophthalmic drug and does not treat retinal disease directly.

Product profile

Attribute	Fluorescite
Active ingredient	Fluorescein sodium
Concentration	10%, 100 mg/mL
Dosage form	Sterile injectable solution
Route	Intravenous
Primary use	Fluorescein angiography
Sponsor/manufacturer	Alcon Laboratories, Inc.
FDA application	NDA 021223
Therapeutic category	Diagnostic ophthalmic agent
Commercial setting	Retina clinics, ophthalmology practices, hospitals and imaging centers
Patent dependence	Low
Generic exposure	High

Fluorescein angiography remains relevant in retinal diagnosis, although optical coherence tomography, optical coherence tomography angiography, fundus photography and wide-field imaging have reduced the need for angiography in some workflows. Fluorescein injection remains useful when clinicians need dynamic visualization of leakage, nonperfusion, neovascularization or retinal vascular abnormalities.

What is the FDA regulatory status of Fluorescite?

Fluorescite is an FDA-approved prescription diagnostic injection. The product is associated with Alcon’s NDA 021223 and is regulated as a drug rather than as a medical device. The approval covers the injectable fluorescein formulation used for ophthalmic angiography. [1]

The product’s regulatory value comes from manufacturing compliance, sterile injectable quality and continued market availability. It does not rely on current clinical exclusivity. Fluorescein sodium has been used for decades, and the underlying diagnostic concept is established.

FDA regulatory characteristics

Regulatory issue	Assessment
FDA approval	Yes
New chemical entity exclusivity	None currently relevant
Orphan-drug exclusivity	No
Pediatric exclusivity	No publicly identified current protection
Regulatory exclusivity driver	Product approval and manufacturing compliance
ANDA competition	Present for fluorescein sodium injection
Current commercial risk	Supply interruption, quality events and price competition

The FDA label identifies important risks, including hypersensitivity reactions, anaphylaxis, nausea, vomiting and extravasation-related complications. These risks apply to fluorescein sodium products generally and do not create meaningful product differentiation for Fluorescite. [1]

What patents protect Fluorescite?

No meaningful current patent moat is associated with the fluorescein sodium active ingredient or the conventional 10% injectable formulation. Fluorescein sodium is an old compound, and the commercial product is exposed to generic substitution and competing injectable products.

Patent estate assessment

Patent category	Commercial relevance to Fluorescite
Active-ingredient patent	Expired or unavailable as a barrier
Composition patent	No meaningful current barrier identified
Formulation patent	No publicly significant blocking estate identified
Method-of-use patent	Conventional angiography use is not a current exclusivity platform
Device patent	Not central to Fluorescite
Manufacturing patent	Process know-how may matter operationally but is not a market-wide exclusion right
Orange Book patent protection	No material current patent protection identified

The commercial distinction is important. A sterile injectable manufacturer may possess proprietary process controls, container-closure specifications, supplier relationships or quality systems. Those assets can make market entry difficult, but they do not provide the same protection as an unexpired patent.

What is the Orange Book status of Fluorescite?

Fluorescite’s commercial value is not based on Orange Book patent listings. The relevant competitive pathway is the FDA’s abbreviated drug approval framework for generic fluorescein sodium injections, together with conventional approvals and supply arrangements.

For a product such as Fluorescite, Orange Book exposure is principally a signal of limited patent-based delay to generic entry. A generic applicant does not need to overcome a long-lived compound or formulation patent estate. The central barriers are instead:

Sterile manufacturing capability.
FDA inspection and compliance history.
Demonstration of pharmaceutical equivalence.
Reliable supply of injectable product.
Commercial access to ophthalmology practices and hospitals.
Ability to compete at low unit prices.

An applicant may use a Paragraph IV certification if a listed patent exists, but Fluorescite is not generally regarded as a major Paragraph IV litigation target. The absence of a substantial patent estate reduces litigation risk and increases the importance of manufacturing economics.

How many patents cover Fluorescite?

No material active patent portfolio is publicly associated with Fluorescite as a commercial product. The practical answer is that Fluorescite has little or no enforceable product-level patent protection capable of delaying generic fluorescein sodium injection.

This differs from patented ophthalmic therapies such as anti-VEGF products, sustained-release implants and drug-device combinations. Fluorescite’s protection is based on regulatory approval, brand recognition and supply execution.

Which companies compete with Fluorescite?

Competition comes from branded and generic fluorescein sodium injections. The principal competitive products have historically included AK-Fluor from Akorn and other fluorescein sodium injection products marketed by generic or specialty injectable manufacturers.

Competitive landscape

Competitor type	Representative position	Competitive effect
Alcon	Fluorescite	Brand credibility, established ophthalmic distribution
Akorn	AK-Fluor	Direct branded or specialty injectable competition
Generic manufacturers	Fluorescein sodium injection	Price pressure and substitution
Hospital suppliers	Contracted injectable supply	Purchasing leverage and formulary pressure
Imaging alternatives	OCT, OCTA and fundus imaging	Potential reduction in procedure demand

The competitive market is narrower than the overall ophthalmology market. Fluorescein injection is a low-frequency diagnostic input purchased by specialized providers. A supplier with dependable inventory can retain share even without patent protection because clinics are sensitive to procedure disruption and product substitution.

What formulations are protected by Fluorescite?

The conventional 10% sterile injectable formulation does not appear to have a meaningful current patent barrier. Its value lies in formulation quality and regulatory compliance rather than novel pharmaceutical science.

Formulation economics

The formulation must meet requirements for:

Sterility.
Stability.
Particulate control.
Accurate fluorescein sodium concentration.
Container-closure integrity.
Compatibility with intravenous administration.
Consistent color and visual quality.
Packaging suitable for single-use administration.

These requirements create manufacturing and quality barriers. They do not prevent an approved competitor from marketing an equivalent product.

The product is typically supplied in single-dose vials. Unit economics are affected by vial size, fill-finish costs, packaging, shipping, wastage and the purchasing practices of retina clinics. Small-volume injectable products can have unfavorable manufacturing economics because each vial requires separate quality testing and distribution handling.

When does Fluorescite lose exclusivity?

Fluorescite has no significant remaining market exclusivity in the conventional pharmaceutical sense. The original approval and any historical regulatory protections do not prevent current generic competition.

Exclusivity timeline

Event	Timing or status
Fluorescein sodium clinical use	Established for decades
Fluorescite FDA approval	Associated with NDA 021223; approval reported in FDA product records
Current NCE exclusivity	None
Current orphan exclusivity	None
Current pediatric exclusivity	None identified
Current patent-based exclusivity	No material protection identified
Generic competition	Present
Current protection	Brand, supply and quality execution

The relevant “loss of exclusivity” event occurred long before the present market. Fluorescite is best analyzed as a mature, off-patent injectable diagnostic rather than a product approaching a future patent cliff.

What is the financial trajectory of Fluorescite?

Alcon does not disclose Fluorescite net sales, gross margin or operating profit separately in its annual reports. The company’s public reporting aggregates products within broader ophthalmic categories. A precise Fluorescite revenue series therefore cannot be derived from Alcon’s SEC filings. [2]

The product’s financial trajectory is likely mature to declining on a unit basis, with revenue volatility caused by procedure volumes and supply conditions. Pricing can rise during shortages or manufacturing disruptions, but long-term pricing power is constrained by generic alternatives.

Revenue drivers

Driver	Directional impact
Retinal imaging procedure volume	Positive
Retina specialist activity	Positive
Expansion of ophthalmology services	Positive
Use of OCT and OCTA instead of angiography	Negative
Generic substitution	Negative
Supply interruptions by competitors	Positive for available suppliers
Hospital purchasing consolidation	Negative for price
Product quality or recall event	Negative
Alcon distribution reach	Positive

Fluorescite can produce stable cash flow even at modest sales levels because it is a mature product with limited clinical-development expense. Its profitability depends on manufacturing scale, plant utilization, product yield, logistics and commercial overhead. The product is unlikely to require substantial promotional investment compared with prescription retinal therapies.

What revenue exposure does Fluorescite create for Alcon?

Fluorescite is unlikely to represent a material share of Alcon’s consolidated revenue. Alcon’s financial exposure is concentrated in surgical products, contact lenses and higher-value ophthalmic pharmaceuticals. The company’s annual reports describe broad segment performance rather than individual sales for Fluorescite. [2]

The product may still have strategic value because it supports Alcon’s ophthalmic portfolio and distribution relationships. A low-revenue diagnostic product can help maintain account access with retina clinics and hospitals, but the financial effect is limited unless supply constraints create unusual pricing or the product is part of a broader account contract.

Financial risk profile

Risk	Estimated business significance
Patent expiry	Low, already reflected in market structure
Generic price erosion	Moderate
Supply disruption	Moderate to high relative to product size
Clinical substitution by imaging technology	Moderate
Regulatory manufacturing event	High at product level
Consolidated Alcon earnings exposure	Low
Cash-flow stability	Moderate if supply remains reliable

What generic launch risks exist for Fluorescite?

Generic launch risk is already present rather than prospective. The principal risk is continued price competition from approved or distributable fluorescein sodium injection products.

A new generic entrant would likely compete through:

Lower acquisition cost.
Hospital and group-practice contracting.
Reliable fill-finish capacity.
Broad distributor access.
Shorter lead times during supply disruptions.

The absence of a substantial patent estate means a new entrant would not face a major patent litigation barrier. The more important regulatory risks are FDA inspection findings, sterile manufacturing deficiencies, product shortages and recalls.

For Alcon, the most credible downside scenario is gradual erosion of share and price as buyers standardize around equivalent injections. The most favorable scenario is retention of demand through dependable supply, clinician familiarity and distribution performance.

What patent litigation and Paragraph IV activity affect Fluorescite?

No major public patent litigation campaign or high-profile Paragraph IV dispute is generally associated with Fluorescite. The product’s old active ingredient and conventional formulation do not create the litigation profile seen with patented retinal drugs.

Litigation assessment

Issue	Current assessment
Compound patent litigation	Not material
Formulation patent litigation	Not material
Method-of-use litigation	Not material
Paragraph IV threat	Low as a litigation event
Generic entry threat	Already established
Biosimilar litigation	Not applicable

A biosimilar pathway does not apply because Fluorescite is a conventional small-molecule diagnostic drug, not a biologic. Competitive products are generics or other approved fluorescein sodium injections.

How does Fluorescite compare with branded retinal drugs?

Fluorescite has a fundamentally different commercial profile from anti-VEGF products such as Eylea, Vabysmo, Lucentis and Beovu.

Dimension	Fluorescite	Branded retinal biologics
Clinical role	Diagnostic imaging agent	Therapeutic treatment
Active ingredient	Small molecule	Biologic
Patent dependence	Low	High
Exclusivity	None material	Patent and regulatory exclusivity
Administration	Intravenous diagnostic injection	Intravitreal injection
Revenue per procedure	Low	High
Biosimilar relevance	None	Increasing
Primary risk	Generic price and supply	Patent expiry, biosimilar entry and reimbursement
Development cost	Low for mature product	High
Financial volatility	Supply and procedure driven	Volume, price and reimbursement driven

Fluorescite is therefore a low-value, operationally sensitive product in an ophthalmology market dominated financially by therapeutic medicines and surgical technologies.

What geographic coverage does Fluorescite have?

Fluorescite is primarily relevant to the U.S. market through its FDA approval and Alcon’s U.S. commercial infrastructure. Equivalent fluorescein products are marketed internationally under different brand names, regulatory approvals and distributor arrangements.

Geographic expansion does not create a single global exclusivity position. Each jurisdiction applies its own drug approval, labeling, pharmacovigilance, manufacturing and distribution requirements. The product’s mature chemistry makes regulatory approval more accessible than for a novel drug, but sterile injectable compliance remains a central requirement.

How strong is the Fluorescite patent estate?

The patent estate is weak as a source of exclusivity and moderate as a commercial asset only when combined with Alcon’s manufacturing and distribution capabilities.

Overall assessment

Category	Rating
Compound protection	Weak
Formulation protection	Weak
Method-of-use protection	Weak
Orange Book leverage	Low
Generic entry barrier	Low to moderate
Manufacturing barrier	Moderate
Brand and distribution value	Moderate
Long-term pricing power	Low
Litigation protection	Low

The product’s defensibility comes from execution, not intellectual property. A supplier that maintains FDA-compliant production and avoids stockouts can preserve a commercial position despite generic competition.

Key Takeaways

Fluorescite is Alcon’s FDA-approved fluorescein sodium 10% injection for diagnostic ophthalmic angiography.
The product has no meaningful current compound, formulation or method-of-use patent moat.
Generic competition is established, and Paragraph IV litigation is not the principal market risk.
Biosimilar competition is irrelevant because Fluorescite is a conventional small-molecule drug.
Alcon does not disclose standalone Fluorescite revenue, margins or volume.
The product’s financial profile is mature, low-growth and operationally sensitive.
Long-term demand is supported by retinal diagnostics but pressured by OCT, OCTA and other imaging technologies.
Manufacturing reliability, sterile injectable compliance, distribution and supply continuity matter more than patents.
Fluorescite is unlikely to have material exposure to consolidated Alcon earnings, but it can retain value as a stable ophthalmic portfolio product.

FAQs About Fluorescite Market and Patent Risk

Is Fluorescite still under patent protection?

No material current patent protection is associated with Fluorescite’s conventional fluorescein sodium injection formulation. Its market position depends on FDA approval, manufacturing quality, brand recognition and distribution.

Can a generic manufacturer launch fluorescein sodium injection?

Yes. Generic fluorescein sodium injections compete with Fluorescite. Entry depends primarily on FDA approval, sterile manufacturing capability, pharmaceutical equivalence and commercial supply economics.

Is Fluorescite a biologic subject to biosimilar competition?

No. Fluorescite is a small-molecule fluorescein sodium injection. Biosimilar approval and litigation frameworks do not apply.

Does Alcon report Fluorescite sales separately?

No. Alcon’s public financial reporting does not identify Fluorescite as a standalone revenue category. Product-level sales, margins and unit volumes are not separately disclosed in its principal public filings.

What is the largest commercial threat to Fluorescite?

The largest threats are generic price competition, declining use of fluorescein angiography in workflows that rely on OCT or OCTA, and supply or manufacturing disruption. Patent expiry is not a current forward-looking threat because the product is already off-patent in practical market terms.

References

U.S. Food and Drug Administration. (n.d.). Fluorescite (fluorescein injection, USP) prescribing information. FDA Drugs@FDA and product labeling database.
Alcon Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2023. U.S. Securities and Exchange Commission.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. FDA, Center for Drug Evaluation and Research.
U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. FDA.

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	10
Patent Applications:	9
What excipients (inactive ingredients) are in FLUORESCITE?	FLUORESCITE excipients list
DailyMed Link:	FLUORESCITE at DailyMed

Drug Class	Diagnostic Dye
Mechanism of Action	Dyes

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