CYTALUX Drug Patent Profile

When do Cytalux patents expire, and what generic alternatives are available?

Cytalux is a drug marketed by On Target Labs and is included in one NDA. There are six patents protecting this drug.

The generic ingredient in CYTALUX is pafolacianine sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pafolacianine sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Cytalux

Cytalux was eligible for patent challenges on November 29, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 26, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for CYTALUX

US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	6
What excipients (inactive ingredients) are in CYTALUX?	CYTALUX excipients list
DailyMed Link:	CYTALUX at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CYTALUX

NDA:

214907

Dosage:

SOLUTION;INTRAVENOUS

^*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 CYTALUX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Abramson Cancer Center at Penn Medicine	EARLY_PHASE1
On Target Laboratories, LLC	PHASE4
Cedars-Sinai Medical Center	PHASE4

See all CYTALUX clinical trials

Pharmacology for CYTALUX

Drug Class	Optical Imaging Agent
Mechanism of Action	Fluorescence Contrast Activity

US Patents and Regulatory Information for CYTALUX

CYTALUX is protected by six US patents and two FDA Regulatory Exclusivities.

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
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes			Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes			Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes			Y	Y

International Patents for CYTALUX

When does loss-of-exclusivity occur for CYTALUX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

Spain

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 CYTALUX around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2013381391
Australia	2013383382
Australia	2013383386
Australia	2017203340
Brazil	112015022810

Cytalux Market Dynamics and Financial Trajectory

Last updated: August 12, 2026

Cytalux, the trade name for pafolacianine sodium, is a first-in-class fluorescence imaging agent used during cancer surgery. On Target Laboratories commercializes the product in the United States. Cytalux received FDA approval for ovarian cancer surgery in November 2021 and expanded into lung cancer surgery in December 2023. Its commercial trajectory depends on procedure adoption, hospital reimbursement, access to compatible near-infrared imaging systems, and expansion into additional folate-receptor-positive cancers.

The product has a differentiated clinical position but a narrow initial market. On Target Laboratories is privately held and does not publish audited product revenue, making precise sales or profitability estimates unavailable. The most important financial value drivers are procedure volume, utilization per surgical center, pricing, and future label expansion.

What is Cytalux and how does it work?

Cytalux is an intravenous optical imaging agent containing pafolacianine sodium. It binds folate receptors that are overexpressed on many epithelial cancer cells. During surgery, the agent produces near-infrared fluorescence that can help surgeons identify malignant tissue not readily visible under white light.

The FDA-approved dose is 0.025 mg/kg administered intravenously approximately one to nine hours before surgery. Cytalux is used as an adjunct to standard visual and tactile inspection. It does not replace pathology, white-light visualization, or the surgeon's clinical judgment. [1]

The commercial product requires:

• Cytalux drug acquisition;
• intravenous administration before surgery;
• a compatible near-infrared fluorescence imaging system;
• trained operating-room personnel; and
• hospital and payer workflow integration.

This creates a higher implementation burden than a conventional injectable drug used outside the operating room.

When did Cytalux receive FDA approval?

FDA milestone	Date	Commercial significance
Original approval for ovarian cancer surgery	Nov. 29, 2021	Established Cytalux as the first FDA-approved folate-receptor-targeted intraoperative imaging agent for this use
Ovarian cancer commercial launch	2022	Initiated sales to hospitals and surgical centers
Expanded approval for lung cancer surgery	Dec. 2023	Increased addressable procedures and added a larger thoracic oncology market
Current regulatory pathway	NDA approval	Cytalux is a small-molecule drug, not a biologic or biosimilar

The ovarian indication covers adult women with ovarian cancer when Cytalux is used as an adjunct for intraoperative identification of malignant tissue. The lung indication covers adults with cancer undergoing pulmonary resection. [1,2]

The lung indication is commercially important because lung cancer surgery is performed at substantially higher annual volumes than ovarian cancer surgery in the United States. The value of the expansion depends on the proportion of eligible patients treated at hospitals with fluorescence-capable equipment.

How large is the Cytalux market?

Cytalux addresses a procedure-linked market rather than a traditional chronic-drug market. Revenue is generated when a surgical procedure occurs, so sales depend on operating-room scheduling, cancer incidence, resection rates, and hospital purchasing behavior.

Ovarian cancer opportunity

The ovarian cancer market is medically important but commercially constrained by:

• lower annual surgical volume than lung cancer;
• concentration of complex cases in academic and tertiary centers;
• variable folate receptor expression;
• competing surgical priorities;
• the need for specialized imaging equipment.

Cytalux can generate high value per procedure if it improves detection of otherwise occult malignant tissue and reduces residual disease. Its economic value is less obvious when the drug adds cost without changing the surgical plan or postoperative management.

Lung cancer opportunity

The lung cancer expansion provides the main near-term growth opportunity. Lung cancer has a larger surgical population and a broader network of thoracic surgery centers. Cytalux may be used to identify pulmonary lesions, additional malignant foci, or margins during resection.

Adoption remains dependent on whether surgeons believe fluorescence changes intraoperative decisions. A hospital may also need to standardize imaging equipment, drug ordering, dosing, and operating-room scheduling before using Cytalux routinely.

Procedure-based revenue model

Cytalux has several commercial characteristics of a specialty procedural product:

Commercial factor	Effect on Cytalux
Per-procedure dosing	Links revenue directly to surgery volume
Short administration-to-surgery interval	Supports same-day or scheduled procedural use
Hospital purchasing	Creates formulary and budget-approval requirements
Imaging equipment dependence	Limits use at centers without compatible systems
Oncology center concentration	Facilitates focused sales but restricts early geographic reach
Label expansion	Can increase value without changing the core manufacturing platform

Public materials have reported a wholesale acquisition price of approximately $3,500 per dose, although actual hospital net pricing can differ by contract, payer, and purchasing channel. [3]

At that price, 10,000 annual procedures would represent approximately $35 million in gross product value before discounts, chargebacks, distribution costs, and other deductions. This calculation is an economic sensitivity, not reported Cytalux revenue.

What is the financial trajectory of Cytalux?

On Target Laboratories is a private company. It does not provide the same quarterly product-sales disclosure as a public pharmaceutical company. Publicly available information therefore supports a commercialization-stage assessment rather than a verified revenue forecast.

Commercial development stages

Period	Financial and operating stage
Before 2021	Clinical development, regulatory preparation, and capital-intensive manufacturing scale-up
2021	FDA approval created a commercial asset but did not establish recurring revenue
2022	Initial launch focused on ovarian cancer centers and early adopter hospitals
2023	Commercial infrastructure expanded; lung cancer approval improved the growth case
2024 onward	Revenue potential shifted toward utilization growth, thoracic surgery adoption, reimbursement execution, and new indications

The financial trajectory likely follows a staged curve:

1. Early revenue from high-volume academic cancer centers.
2. Expansion into community hospitals with appropriate fluorescence infrastructure.
3. Higher procedure utilization at existing accounts.
4. Incremental growth from new cancer indications.
5. Potential operating leverage if sales and manufacturing costs grow more slowly than procedure volume.

The principal limitation is that Cytalux must earn adoption procedure by procedure. A broad FDA label does not guarantee routine use. Hospitals may initially reserve the product for complex cases, clinical champions, or procedures where occult disease would materially affect surgical management.

What reimbursement factors affect Cytalux sales?

Reimbursement is a central commercial risk because Cytalux is administered in the hospital and tied to a surgical episode.

Hospitals evaluate:

• whether the drug is separately reimbursed or absorbed into a procedure payment;
• whether the relevant payer covers the imaging adjunct;
• whether the product qualifies for temporary or transitional payment mechanisms;
• whether the hospital can capture downstream savings from better lesion identification;
• whether use increases operating-room time or delays turnover.

The product's value proposition is strongest when fluorescence produces an actionable result. A hospital may accept the drug's cost when it helps avoid a second procedure, improves resection completeness, or identifies lesions that change the surgical approach.

The economics are weaker when the product is used without a measurable change in care. This creates a need for hospital-level evidence, surgical workflow data, and health-economic studies in addition to regulatory approval.

What patent and exclusivity protection does Cytalux have?

Cytalux is protected through a combination of drug patents, method-of-use patents, formulation and manufacturing know-how, regulatory exclusivity, trademarks, and operational expertise. The commercial value of the estate depends less on one compound patent than on the ability to protect use in specific surgeries and cancer populations.

Patent categories relevant to Cytalux

Protection category	Commercial role
Pafolacianine or OTL38 composition patents	Protect the active imaging compound and related chemical forms
Folate-receptor targeting patents	Cover ligand-targeting chemistry and tumor imaging applications
Method-of-use patents	Protect use in ovarian, lung, and other cancer surgeries
Formulation and dosing claims	Cover injectable presentation, dose, timing, and administration
Manufacturing know-how	Protect quality, purity, scale-up, and reproducibility
Regulatory exclusivity	Delays certain competing FDA approvals even where patent claims are limited

The FDA Orange Book should be used to identify the current listed patents, expiration dates, pediatric exclusivity, and any patent-term extension. The relevant patent landscape can change through patent-term adjustments, terminal disclaimers, continuations, and litigation outcomes. [4]

Cytalux is a small molecule, so it does not have the biologic exclusivity structure associated with monoclonal antibodies. Biosimilar risk is therefore not a principal near-term issue. The more relevant threats are generic pafolacianine products, alternative fluorescent agents, and competing image-guided surgery platforms.

When does Cytalux lose exclusivity?

The FDA approval date alone does not establish a single loss-of-exclusivity date. The practical generic-entry date depends on:

• Orange Book-listed patents;
• patent-term extension or adjustment;
• pediatric exclusivity;
• any settlement with an abbreviated new drug application applicant;
• regulatory exclusivity attached to the NDA;
• formulation or method-of-use patents not required for a generic approval;
• the commercial feasibility of producing a sterile fluorescent injectable.

Cytalux received five-year new chemical entity exclusivity with its original approval, subject to the statutory framework. The lung indication does not ordinarily reset the entire product's NCE exclusivity period. New indication, orphan, pediatric, or other exclusivity can affect individual uses only where the statutory requirements are met. [1,5]

Even after a generic launch, market substitution may be slower than for an oral tablet. Hospitals must validate the product, coordinate imaging compatibility, establish dosing protocols, and obtain surgeon acceptance. Manufacturing a sterile, consistent, fluorescent drug may also create entry barriers.

Which companies challenge Cytalux commercially?

Cytalux competes across three groups.

Other fluorescent imaging agents

The closest commercial competitors are agents used with intraoperative fluorescence systems. Examples include indocyanine green, which is widely used for vascular and tissue perfusion imaging, and 5-aminolevulinic acid products such as Gleolan, which is approved for visualization of malignant glioma during surgery. These products do not have the same folate-receptor targeting or the same approved cancer indications, but they compete for hospital budgets and surgeon attention. [6,7]

Imaging-system manufacturers

Cytalux adoption depends on near-infrared imaging platforms. Companies that sell or support fluorescence-capable surgical systems can influence product access, training, and procedure economics. The drug and device components therefore form a commercial ecosystem rather than a stand-alone pharmaceutical market.

Future targeted imaging developers

Academic groups and biotechnology companies are developing targeted fluorescent agents against tumor markers such as folate receptor alpha, prostate-specific membrane antigen, carcinoembryonic antigen, and other surface proteins. These programs could compete with Cytalux in specific cancers if they demonstrate superior tumor-to-background ratios, broader eligibility, lower toxicity, easier dosing, or better reimbursement.

How strong is the Cytalux competitive position?

Cytalux has four meaningful advantages:

• first-mover status in folate-receptor-targeted intraoperative imaging;
• FDA approval in two major surgical oncology settings;
• a clinically differentiated mechanism;
• a commercial platform that may support additional indications.

Its weaknesses are equally material:

• limited use to surgery;
• dependence on specialized equipment;
• a narrow initial customer base;
• unclear routine-use economics;
• competition from lower-cost, non-targeted fluorescent agents;
• limited public financial transparency;
• possible future generic exposure after patent and exclusivity barriers decline.

The strongest defensive asset is the combination of regulatory approval, clinical workflow integration, surgeon familiarity, and hospital-specific implementation. Patent protection alone may not preserve premium pricing if competing agents provide comparable surgical information at lower cost.

What generic launch risks exist for Cytalux?

The most likely generic-entry path would involve an ANDA referencing pafolacianine. A Paragraph IV certification could challenge Orange Book-listed patents before expiration. Such a filing could lead to patent litigation and a potential 30-month stay of approval under the Hatch-Waxman framework, depending on the timing and statutory requirements. [8]

Generic launch risk is moderated by:

• the complexity of sterile injectable manufacturing;
• limited immediate procedure volume;
• the need for compatible imaging systems;
• surgeon preference and hospital protocol inertia;
• possible method-of-use and formulation claims;
• the need to establish reliable supply and quality.

Risk increases if a generic manufacturer can produce an equivalent injectable at a substantial discount and hospitals treat the agent as interchangeable. Risk also increases if Cytalux does not expand utilization beyond specialist centers before patent expiry.

What licensing and partnering opportunities exist for Cytalux?

The product's most logical partnering opportunities are commercial rather than purely scientific. Potential counterparties include:

• surgical imaging companies;
• hospital-distribution organizations;
• oncology-focused pharmaceutical companies;
• regional specialty distributors;
• developers of companion diagnostics or folate-receptor testing;
• global partners with established thoracic and gynecologic oncology sales forces.

A large pharmaceutical partner could accelerate international registration and sales coverage. An imaging-company partnership could reduce equipment barriers and improve operating-room adoption. A diagnostic partnership could support patient selection, although the current FDA-approved use does not require a separate companion diagnostic.

No major publicly disclosed licensing transaction establishes a broad global commercial partnership for Cytalux. On Target Laboratories remains the central commercial entity associated with the product in the United States.

What is the likely Cytalux revenue outlook?

The base case is gradual growth rather than an immediate blockbuster profile. The lung cancer indication materially expands the addressable market, but adoption will likely remain concentrated in hospitals able to support fluorescence-guided thoracic surgery.

Revenue drivers

• greater use in lung resections;
• increased ovarian cancer penetration;
• expansion to community hospitals;
• improved reimbursement;
• additional indications using folate-receptor targeting;
• higher repeat utilization at existing accounts;
• international approvals or licensing.

Revenue constraints

• low awareness among surgeons outside specialist centers;
• limited imaging-system availability;
• hospital budget controls;
• procedure cancellations and variable surgical volumes;
• uncertain incremental clinical benefit in routine cases;
• competitive agents and future targeted imaging products;
• lack of public evidence of large-scale recurring sales.

The most credible valuation framework is procedure-based. Investors and licensing counterparties should model treated procedures, net price per dose, account penetration, utilization frequency, gross-to-net deductions, and salesforce productivity rather than relying on the total cancer incidence population.

Key Takeaways

• Cytalux is pafolacianine sodium, a targeted near-infrared imaging agent commercialized by On Target Laboratories.
• FDA approvals cover intraoperative use in ovarian cancer and lung cancer surgery.
• Lung cancer is the main expansion opportunity because of its larger surgical volume.
• The product operates in a procedure-driven market and requires compatible fluorescence imaging equipment.
• On Target Laboratories is private, so audited product revenue and profitability are not publicly disclosed.
• Publicly reported pricing has been approximately $3,500 per dose, but hospital net pricing can vary.
• Patent protection spans composition, targeting chemistry, methods of use, formulation, and manufacturing.
• Generic risk is governed by the current Orange Book estate and potential Paragraph IV challenges.
• Biosimilars are not the relevant threat because Cytalux is a small molecule.
• Long-term value depends on utilization, reimbursement, additional indications, and evidence that fluorescence changes surgical management.

FAQs About Cytalux Market and Exclusivity

Is Cytalux a chemotherapy drug?

No. Cytalux is a fluorescent surgical imaging agent. It helps identify malignant tissue during surgery and does not treat cancer as a cytotoxic or targeted systemic therapy.

Does Cytalux require a companion diagnostic?

The FDA-approved indications do not require a separate companion diagnostic. Clinical use depends on the approved indication, appropriate patient selection, dosing, and compatible imaging equipment.

Can Cytalux be used in colorectal or prostate cancer surgery?

Those uses would require supporting evidence and appropriate regulatory authorization. Folate-receptor biology may support research in additional cancers, but research potential does not establish an approved commercial indication.

Is Cytalux covered by Medicare?

Coverage depends on the surgical procedure, care setting, payment system, and applicable Medicare policy. Hospital reimbursement treatment can differ from physician-office or ambulatory-surgery payment.

What is the main investment risk for Cytalux?

The principal risk is slower-than-expected procedure adoption. FDA approval creates market access, but recurring revenue depends on surgeons using the product routinely and hospitals receiving adequate economic value from each procedure.

References

1. U.S. Food and Drug Administration. (2023). Cytalux (pafolacianine sodium) prescribing information.
2. U.S. Food and Drug Administration. (2023, December 13). FDA approves pafolacianine for use in lung cancer surgery.
3. On Target Laboratories. (2022). Cytalux product and commercial information.
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
5. U.S. Code, 21 U.S.C. § 355(j). Hatch-Waxman abbreviated new drug application provisions.
6. U.S. Food and Drug Administration. (2018). Gleolan (aminolevulinic acid hydrochloride) prescribing information.
7. U.S. Food and Drug Administration. (2018). Indocyanine green prescribing information.
8. U.S. Code, 35 U.S.C. § 271(e)(2). Patent infringement provisions for abbreviated new drug applications.