When do the AK-FLUOR 10% patents expire, and when will generic AK-FLUOR 10% be available?

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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
Long Grove Pharms	AK-FLUOR 10%	fluorescein sodium	INJECTABLE;INTRAVENOUS	022186-001	Aug 8, 2008	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: August 2, 2026

AK-FLUOR 10% is a mature fluorescein sodium injection used primarily for ophthalmic diagnostic imaging. Its commercial profile is defined by low therapeutic differentiation, generic competition, hospital procurement, limited product-level disclosure, and supply-chain sensitivity. The product has no apparent biologic or biosimilar exposure and no durable composition-of-matter patent position. Public filings do not disclose AK-FLUOR-specific revenue, making a precise product-level financial forecast unavailable. The defensible outlook is a small, mature injectable franchise with flat-to-declining volume, pricing pressure, and potential upside from supply disruptions affecting competitors.

What is AK-FLUOR 10% and how is it used?

AK-FLUOR 10% contains fluorescein sodium at a concentration of 100 mg/mL. It is administered by intravenous injection for diagnostic fluorescein angiography and related ophthalmic imaging procedures. The product is used in hospitals, ophthalmology practices, ambulatory surgical centers, and diagnostic imaging settings.

Attribute	AK-FLUOR 10%
Active ingredient	Fluorescein sodium
Strength	10%, equivalent to 100 mg/mL
Dosage form	Sterile injectable solution
Administration	Intravenous
Primary use	Diagnostic ophthalmic angiography
Therapeutic category	Ophthalmic diagnostic agent
Regulatory pathway	Legacy FDA new drug application
Product sponsor historically associated with product	Akorn
Biosimilar exposure	None
Primary commercial buyers	Hospitals, ophthalmology centers, distributors
Market type	Mature branded-generic injectable

The product is diagnostic rather than therapeutic. Demand depends on the number of angiography procedures, ophthalmology utilization, hospital budgets, and the availability of competing fluorescein sodium injections.

What is the FDA regulatory status of AK-FLUOR 10%?

AK-FLUOR is associated with FDA NDA 017290 and is identified in FDA labeling as a fluorescein sodium injection product. The FDA-approved formulation is a sterile injectable product intended for diagnostic use. The prescribing information includes warnings related to hypersensitivity reactions, including severe reactions after intravenous administration. [1]

The product’s regulatory value comes from manufacturing compliance, injectable quality controls, and continued commercial availability rather than from modern regulatory exclusivity.

FDA regulatory characteristics

Regulatory factor	Assessment
FDA approval	Legacy approved injectable product
New chemical entity exclusivity	Expired
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	Not identified as a current commercial driver
180-day generic exclusivity	No current evidence of a relevant blocking period
REMS	No major REMS-based commercial barrier identified
Biosimilar pathway	Not applicable
Main regulatory risk	Manufacturing compliance and supply continuity

The commercial distinction between AK-FLUOR and competing products is limited. Customers generally evaluate concentration, presentation, price, supply reliability, labeling, and distributor availability.

What patents protect AK-FLUOR 10%?

No current composition-of-matter patent appears to protect fluorescein sodium as used in AK-FLUOR. Fluorescein sodium is an old diagnostic compound, and any historical compound patent rights have expired.

The remaining intellectual-property analysis is more relevant to formulation, manufacturing, packaging, or device configuration than to the active ingredient.

Patent category	Likely commercial relevance
Active ingredient patent	None of practical current value
New chemical entity patent	Expired
Injectable formulation patent	Limited or absent for the legacy product
Method-of-use patent	Limited; diagnostic angiography use is longstanding
Manufacturing patent	Potentially relevant only if covering a specific process
Container or closure patent	Possible, but unlikely to create broad market exclusivity
Labeling exclusivity	Not a material current barrier

The absence of meaningful patent protection means that a competitor can generally pursue an FDA-compliant fluorescein sodium injection without needing a license to AK-FLUOR intellectual property. FDA Orange Book records, rather than patent litigation databases alone, remain the relevant source for determining whether any patents are currently listed against the product’s approved application. [2]

When does AK-FLUOR lose exclusivity?

AK-FLUOR’s meaningful market exclusivity has already expired. The product is a legacy injectable, and its competitive position does not depend on an unexpired patent or regulatory exclusivity period.

The relevant commercial timeline is therefore:

Period	Commercial event
Historical period	Fluorescein sodium becomes established as an ophthalmic diagnostic agent
Legacy FDA approval period	AK-FLUOR enters the regulated injectable market
Patent-expiration period	Any historical compound and early-use protections expire
Generic-market period	Multiple manufacturers can compete through approved injectable products
Current period	Price, supply, manufacturing quality, and distribution determine share

There is no identifiable future “loss of exclusivity” date comparable to a protected branded medicine. The principal risk is product withdrawal or manufacturing interruption rather than patent expiry.

What is the Orange Book status of AK-FLUOR?

AK-FLUOR is a legacy FDA-approved product, but its commercial position should not be treated as equivalent to a modern, patent-protected branded NDA. The key Orange Book questions are whether the product has active patent listings and whether approved ANDAs reference the product.

For market analysis, the likely conclusions are:

Any historical patent protection is expired or commercially immaterial.
No current patent estate appears to prevent generic competition.
The product’s value is tied to FDA approval and manufacturing capability.
A competitor’s entry would not normally require a patent settlement with the sponsor.
Any Paragraph IV activity would be relevant only if an unexpired Orange Book patent were listed.

Which companies compete with AK-FLUOR 10%?

Competition comes from other fluorescein sodium injection products rather than from therapeutically substitutable ophthalmic drugs. The competitive set can include branded products, authorized generics, and ANDA-approved injections, depending on market availability and distributor supply.

Direct competitors

Direct competitors generally match AK-FLUOR on:

Fluorescein sodium active ingredient
10% concentration
Intravenous diagnostic use
Hospital and ophthalmology purchasing channels
Similar administration and handling requirements

The most important competitive variables are:

Variable	Market effect
Unit price	Drives formulary and distributor preference
Shortage history	Can shift demand rapidly to available suppliers
Presentation size	Affects waste and procedure economics
Injectable quality	Determines hospital acceptance
Distribution	Influences purchasing continuity
Regulatory record	Can affect formulary confidence
Contract terms	Determines share in institutional accounts

Because fluorescein angiography is a specialized procedure, the market is smaller than the markets for therapeutic ophthalmic drugs. However, sterile injectable supply disruptions can produce temporary volume gains for a supplier that remains available.

How strong is the AK-FLUOR patent estate?

The patent estate is weak from a blocking-rights perspective. The product’s defensibility is operational rather than technological.

Patent-strength assessment

Criterion	Rating	Rationale
Composition-of-matter protection	Very weak	Active ingredient is longstanding
Method-of-use protection	Weak	Diagnostic use is established
Formulation differentiation	Weak to moderate	Injectable manufacturing may create execution barriers
Regulatory barrier	Moderate	FDA-quality requirements raise entry costs
Manufacturing complexity	Moderate	Sterility, consistency, and injectable controls matter
Distribution barrier	Moderate	Hospital contracts and distributor access can slow entry
Litigation leverage	Weak	Limited apparent patent basis for exclusion

Manufacturing know-how can still have commercial value. Fluorescein sodium injection requires sterile production, validated processes, quality testing, container-closure integrity, and compliance with current good manufacturing practices. These requirements create a barrier to entry, but they do not create patent exclusivity.

Are there Paragraph IV challenges to AK-FLUOR?

No widely reported Paragraph IV litigation appears to define the current AK-FLUOR market. This is consistent with a legacy product that lacks a commercially significant unexpired patent estate.

A Paragraph IV challenge would require an ANDA applicant to certify that a listed patent is invalid, unenforceable, or not infringed. If no relevant patent is listed, an applicant could use another certification pathway. The practical entry risk is therefore generic competition based on regulatory approval rather than patent litigation.

Litigation issue	Current commercial interpretation
Paragraph IV notice	No prominent public case identified
Patent infringement case	No major reported case defining the product
Settlement agreement	No material public settlement identified
Injunction risk	Low based on the apparent patent position
Main entry route	FDA approval and commercial supply

What formulation patents protect AK-FLUOR?

No broadly recognized formulation patent appears to provide AK-FLUOR with durable market protection. The formulation is a conventional fluorescein sodium sterile injection. Potentially protectable elements could include:

pH control
Concentration and stability
Excipient selection
Container and closure configuration
Light protection
Sterilization process
Manufacturing sequence

These elements may support manufacturing quality or regulatory differentiation, but they are unlikely to block the entire fluorescein sodium injection market unless a narrowly drafted, unexpired patent covers a specific formulation and is listed against the relevant FDA application.

What is the financial trajectory of AK-FLUOR?

AK-FLUOR-specific revenue is not separately reported in publicly available financial disclosures. The product has historically been part of a broader portfolio of injectable, ophthalmic, and specialty pharmaceutical products. A product-level revenue figure, gross margin, market share, or prescription trend cannot be established from issuer filings alone.

The financial trajectory can be assessed through market structure:

Revenue profile

AK-FLUOR is likely to have:

Low absolute revenue relative to major branded drugs
Stable but limited procedure-driven demand
Low promotional spending
High sensitivity to hospital contracting
Pricing pressure from generic competition
Occasional volume spikes during competitor shortages
Margins dependent on manufacturing utilization and quality costs

Base-case financial trajectory

Period	Expected commercial direction
Near term	Flat-to-declining baseline demand
During competitor shortage	Temporary volume and price improvement
After supply normalization	Reversion toward prior market share
Long term	Mature generic erosion unless supply reliability improves
Upside case	Share gains from competitor discontinuation or shortage
Downside case	Revenue loss from manufacturing interruption or sponsor instability

The product does not have the characteristics of a high-growth pharmaceutical asset. There is no evident indication expansion, patent extension, premium formulation, or biologic platform supporting substantial revenue growth.

How does AK-FLUOR compare with competing fluorescein products?

Dimension	AK-FLUOR 10%	Generic fluorescein sodium injection
Active ingredient	Fluorescein sodium	Fluorescein sodium
Diagnostic use	Ophthalmic angiography	Ophthalmic angiography
Patent protection	Limited or expired	Usually limited or expired
Pricing power	Low	Low
Differentiation	Brand familiarity and availability	Price and supply
FDA barrier	Existing approval	ANDA or applicable approval required
Hospital value	Reliable supply and validated quality	Reliable supply and competitive price
Switching risk	Moderate	Moderate
Long-term growth	Limited	Limited

AK-FLUOR can retain accounts even without patent protection if it has dependable supply, distributor coverage, and acceptable quality performance. Conversely, a product with brand recognition can lose share quickly if it experiences shortages or quality-related interruptions.

What licensing deals affect AK-FLUOR?

No material public licensing transaction appears to be central to AK-FLUOR’s current economics. The product is a mature injectable rather than a technology platform that typically generates royalty income or strategic licensing value.

Potential transaction value would more likely arise from:

Product-line acquisition
Asset purchase involving the NDA
Manufacturing or supply agreement
Authorized-generic arrangement
Regional distribution rights

A transaction involving AK-FLUOR would likely be evaluated on contribution margin, regulatory status, manufacturing continuity, customer contracts, and supply obligations rather than on patent value.

What generic entry risks exist for AK-FLUOR?

Generic entry risk is structurally high because the active ingredient and clinical use are established. The primary barriers are operational:

FDA approval of a sterile injectable product.
Validation of aseptic manufacturing or sterilization controls.
Demonstration of product quality and stability.
Reliable access to injectable packaging.
Hospital and distributor qualification.
Ability to maintain supply during demand fluctuations.

Generic entry may reduce price, but the market’s small size can limit the number of viable competitors. This creates a countervailing dynamic: low legal barriers encourage entry, while limited revenue potential and injectable manufacturing costs discourage excessive competition.

What is the geographic coverage of AK-FLUOR?

AK-FLUOR’s principal commercial relevance is the United States market, where the product is regulated under FDA approval and distributed through U.S. hospital and pharmaceutical channels.

Outside the United States, fluorescein sodium injections may be marketed under different brand names, local registrations, or generic labels. U.S. FDA approval does not automatically create rights in Europe, Canada, Japan, or other jurisdictions. Geographic commercial value depends on separate national approvals, local distributors, and product registration status.

Key Takeaways

AK-FLUOR 10% is a mature fluorescein sodium injectable used for ophthalmic diagnostic imaging.
The product has no apparent meaningful current composition-of-matter or method-of-use exclusivity.
Its economic value is based on FDA approval, manufacturing execution, supply reliability, and distribution.
Public filings do not disclose AK-FLUOR-specific revenue or profit.
Baseline demand is likely stable to declining, with temporary upside during competitor shortages.
Paragraph IV litigation and patent settlements do not appear to be major current market drivers.
Biosimilar risk is irrelevant because AK-FLUOR is a small-molecule diagnostic injection.
The largest commercial risks are manufacturing interruption, sponsor instability, price competition, and generic substitution.
The strongest potential upside is share capture following competitor discontinuation or shortage.
The product is better analyzed as a low-revenue, mature injectable asset than as a patent-protected pharmaceutical franchise.

FAQs

Is AK-FLUOR 10% a generic drug?

AK-FLUOR is a branded fluorescein sodium injection. Its active ingredient and diagnostic use are longstanding, and competing generic fluorescein sodium injections can enter the market subject to FDA approval.

Does AK-FLUOR have a patent-protected market?

No meaningful current patent protection is apparent for the active ingredient or established diagnostic use. Any remaining protection would likely relate to narrow formulation, manufacturing, packaging, or process claims.

Can a biosimilar compete with AK-FLUOR?

No. Biosimilars apply to biologic products. AK-FLUOR contains the small molecule fluorescein sodium and competes through generic injectable pathways.

What could increase AK-FLUOR sales?

Sales could increase if competing fluorescein products experience shortages, discontinuations, recalls, or manufacturing problems. A larger ophthalmic imaging procedure base could also support demand, but the product has limited structural growth potential.

Is AK-FLUOR a significant revenue contributor for its manufacturer?

Public company disclosures do not identify AK-FLUOR-specific revenue. Its product characteristics indicate a niche contribution relative to major pharmaceutical franchises, with value concentrated in reliable supply and portfolio continuity.

References

U.S. Food and Drug Administration. (n.d.). AK-FLUOR 10% fluorescein sodium injection prescribing information. FDA/DailyMed labeling.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs database. FDA.
U.S. Food and Drug Administration. (n.d.). Drug shortages database. FDA.
Akorn Operating Company LLC. (n.d.). AK-FLUOR product information and labeling. Product materials.

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
DailyMed Link:	AK-FLUOR 10% at DailyMed

Drug Class	Diagnostic Dye
Mechanism of Action	Dyes

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