Pafolacianine sodium - Generic Drug Details

What are the generic sources for pafolacianine sodium and what is the scope of freedom to operate?

Pafolacianine sodium is the generic ingredient in one branded drug marketed by On Target Labs and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pafolacianine sodium has thirty-five patent family members in twelve countries.

One supplier is listed for this compound.

Summary for pafolacianine sodium

International Patents:	35
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	pafolacianine sodium at DailyMed

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

Constraining patent/regulatory exclusivity:

9,341,629

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 pafolacianine sodium

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

Sponsor	Phase
Mayo Clinic	PHASE3

See all pafolacianine sodium clinical trials

Pharmacology for pafolacianine sodium

Drug Class	Optical Imaging Agent
Mechanism of Action	Fluorescence Contrast Activity

Anatomical Therapeutic Chemical (ATC) Classes for pafolacianine sodium

V04CX	Other diagnostic agents
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for pafolacianine sodium

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
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes	9,333,270		Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes	9,789,208		Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes	9,341,629		Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes	9,254,341		Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes	9,061,057		Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes

International Patents for pafolacianine sodium

Country	Patent Number	Title	Estimated Expiration
Mexico	358184	SINTESIS Y COMPOSICION DE GRUPOS DE ENLACE DE AMINOACIDOS CONJUGADOS CON COMPUESTOS USADOS PARA LA TOMA DE IMAGENES DIRIGIDA DE TUMORES. (SYNTHESIS AND COMPOSITION OF AMINO ACID LINKING GROUPS CONJUGATED TO COMPOUNDS USED FOR THE TARGETED IMAGING OF TUMORS.)
Eurasian Patent Organization	201591802	СИНТЕЗ И КОМПОЗИЦИЯ АМИНОКИСЛОТНЫХ ЛИНКЕРНЫХ ГРУПП, КОНЪЮГИРОВАННЫХ С СОЕДИНЕНИЯМИ, ПРИМЕНЯЕМЫМИ ДЛЯ НАПРАВЛЕННОЙ ВИЗУАЛИЗАЦИИ ОПУХОЛЕЙ
European Patent Office	2968335
World Intellectual Property Organization (WIPO)	2014149073
Australia	2013381391	Fluorescence imaging of inflammatory diseases
China	105492905
Japan	6192799

Pafolacianine sodium Market Analysis and Financial Projection

Last updated: February 16, 2026

What are the current market dynamics for pafolacianine sodium?

Pafolacianine sodium, marketed as Cysview, is a fluorescent imaging agent approved primarily for detecting non-muscle invasive bladder cancer (NMIBC). Its market growth hinges on factors including incidence rates of bladder cancer, advancements in optical imaging technology, and regional regulatory approvals.

Incidence and emerging demand

Bladder cancer accounts for approximately 4.6% of all new cancer cases globally, with an estimated 573,000 new cases in 2020 (WHO, 2022). Non-muscle invasive types represent roughly 75% of these cases, creating a substantial target population for pafolacianine sodium.

Adoption drivers

• Detection sensitivity: Pafolacianine enhances tumor visualization, aiding low-grade and carcinoma in situ detection.
• Regulatory approvals: The U.S. FDA approved pafolacianine in 2021. European regulators granted CE marking in 2020.
• Clinical acceptance: Growing endorsement from urology societies for fluorescence-guided cystoscopy supports adoption.
• Technological integration: Compatibility with existing cystoscopy equipment accelerates uptake.

Market challenges

• Cost considerations: High prices for fluorescent agents and imaging systems limit adoption in resource-limited settings.
• Competitive landscape: Approved contrast agents like blue-light cystoscopy agents (e.g., Hexvix) compete for a share.
• Reimbursement policies: Variability in insurance coverage restrains market penetration.

Regional market outlook

The North American market dominates due to early regulatory approval, high bladder cancer prevalence, and reimbursement infrastructure. Europe follows, with rising adoption in select markets. Emerging regions (Asia-Pacific) exhibit growth potential but face access and affordability hurdles.

What is the financial trajectory for pafolacianine sodium?

Forecasting revenues involves analyzing existing sales figures, pipeline developments, and market expansion prospects.

Revenue estimates

• Initial launch year (2022): Estimated U.S. sales approximate $25-40 million based on early adoption rates (IQVIA, 2023).
• Three-year projection (2023-2025): Growth rate projected at 15-25% annually, driven by increased clinical adoption and expanded indications.

Sales drivers

• Clinical guidelines: Incorporation into standard cystoscopy protocols boosts sales.
• New indications: Investigations into applicability for other cancers (e.g., ovarian, lung) could generate additional revenue.
• Geographic expansion: Regulatory approvals in Japan, Australia, and select Asian nations open new markets.

Cost-related factors

• Manufacturing: Production costs are moderate, but demand scaling may improve margins.
• Marketing: Costs for education and training are significant, particularly during early adoption phases.
• Pricing Trends: Expected stabilization at premium pricing levels ($500-$700 per dose in the U.S.).

Investment considerations

• Companies with proprietary fluorescent agents or imaging hardware could either compete or partner.
• Faster adoption correlates with investment in clinical trials demonstrating broader efficacy.

How does pafolacianine sodium compare with competitors?

Compared to blue-light cystoscopy agents, pafolacianine offers targeted tumor visualization without the need for specialized light sources, simplifying procedural workflows. Market share remains limited but growing with expanded evidence and regulatory approvals.

Summary of key market players

Company	Product	Status	Market Share (est.)	Regulatory Status
FUJIFILM	Cysview	Approved in US, EU	Leading	FDA (2021), CE (2020)
Photocure	Hexvix	Similar agent	Secondary	Approved in US, EU
Others	Various	Under development	Small	Pending or early-stage

What is the projected financial trajectory?

Year	Estimated US Sales	Growth Rate	Regional Expansion Impact
2022	$25-40 million	--	Launch year, initial uptake
2023	$30-50 million	20%	Expanded coverage, adoption
2024	$36-63 million	20%	Broadened indications and markets
2025	$43-75 million	20%	Further expansion, phase II studies

Assumptions underpinning forecasts

• Regulatory approval in additional regions.
• Inclusion in standard guidelines.
• Competitive landscape remains stable.

Key Takeaways

• Pafolacianine sodium addresses unmet needs in bladder cancer detection.
• Market growth relies on increasing adoption, regional approvals, and expanded indications.
• Revenue in the US is projected to reach approximately $43-75 million by 2025, assuming steady growth.
• Competition from existing blue-light agents and reimbursement policies influence market share.
• Long-term prospects depend on clinical validation and strategic collaborations in oncology imaging.

FAQs

1. What factors influence the adoption of pafolacianine sodium?
   Clinical effectiveness, regulatory approvals, cost, reimbursement policies, and compatibility with existing cystoscopy equipment.

2. How does pafolacianine sodium compare to blue-light cystoscopy agents?
   It offers targeted tumor visualization without the need for specialized light sources but faces competition over established agents like Hexvix.

3. What are the key markets for pafolacianine sodium?
   North America, Europe, with growth opportunities in Asia-Pacific regions following regulatory approvals.

4. What are the primary challenges to market expansion?
   Cost barriers, reimbursement variability, competition, and limited awareness outside specialized urology centers.

5. Are new indications being explored for pafolacianine sodium?
   Yes, investigational uses include detection of other cancers such as ovarian and lung, which could diversify revenue streams.

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References

[1] World Health Organization. (2022). Global Cancer Statistics 2020.
[2] IQVIA. (2023). Market Analysis Report on Fluorescent Imaging Agents.
[3] U.S. Food and Drug Administration. (2021). FDA Approval of Pafolacianine.
[4] European Medicines Agency. (2020). Market Authorization for Cysview.