PAFOLACIANINE SODIUM - Generic Drug Details

What are the generic drug sources for pafolacianine sodium and what is the scope of patent protection?

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	9,341,629		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	9,254,341		Y	Y

International Patents for PAFOLACIANINE SODIUM

Country	Patent Number	Title	Estimated Expiration
Brazil	112015022810	síntese e composição de grupos de ligação de aminoácidos conjugados a compostos utilizados para a criação de imagens específicas de tumores
World Intellectual Property Organization (WIPO)	2014149073
Mexico	2015011830	METODOS DE FABRICACION Y SINTESIS DE GRUPOS DE ENLACE DE AMINOACIDOS CONJUGADOS CON COMPUESTOS USADOS PARA LA OBTENCION DE IMAGENES DIRIGIDA DE LOS TUMORES. (METHODS OF MANUFACTURE AND SYNTHESIS OF AMINO ACID LINKING GROUPS CONJUGATED TO COMPOUNDS USED FOR TARGETED IMAGING OF TUMORS.)
Japan	2016512240	蛍光性化合物とコンジュゲートさせたリガンドによる炎症性疾患の蛍光イメージング

Market Dynamics and Financial Trajectory for Pafolacianine Sodium

Last updated: July 30, 2025

Introduction

Pafolacianine sodium, commercially known as Cytalux, represents a new frontier in targeted cancer imaging. Designed to improve intraoperative detection of ovarian and other cancers, this agent offers promising clinical utility. Since its FDA approval in 2021, pafolacianine sodium's market trajectory has garnered increasing interest, driven by technological innovation, unmet medical needs, and competitive dynamics within the oncology diagnostic space.

This analysis examines the current market environment, key drivers and barriers, financial prospects, and strategic considerations shaping pafolacianine sodium’s commercial outlook.

Market Landscape and Clinical Significance

The global oncology imaging market was valued at approximately $4.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 6% through 2030 (Grand View Research). Pafolacianine sodium offers a novel solution, functioning as a near-infrared fluorescent agent that binds to folate receptors overexpressed in many ovarian and lung cancers, enabling real-time tumor visualization during surgery.

Unmet Medical Needs and Clinical Advantages:
Current intraoperative detection methods rely heavily on surgeons’ experience and visual cues, often missing malignant tissue, leading to residual disease and staged reoperations. Pafolacianine sodium can significantly enhance detection sensitivity, reducing residual tumor presence and improving surgical outcomes. Its targeted mechanism confers higher specificity relative to traditional dyes, positioning it as a transformative tool in oncologic surgery.

Market Drivers

1. Expanding Clinical Adoption

Since its FDA approval in 2021, initial clinical implementation has primarily been within academic and high-volume surgical centers. The accumulating evidence demonstrating improved surgical completeness bolsters clinician confidence and accelerates adoption. As more institutions incorporate pafolacianine sodium into surgical workflows, sales volumes are expected to rise correspondingly.

2. Increasing Cancer Incidence and Screening

Global ovarian and lung cancer incidence continues to climb due to aging populations, tobacco use, and environmental factors [1,2]. Early detection and improved surgical resection have direct survival implications. The ability of pafolacianine sodium to enhance intraoperative visualization aligns with broader trends favoring minimally invasive and precision surgical interventions.

3. Regulatory and Reimbursement Pathways

Beyond FDA approval, regulatory endorsements in Europe and strategic reimbursement pathways considerably influence market progression. Pafolacianine sodium’s coverage by healthcare payers, especially in the U.S., will be crucial. Recent dialogues with Centers for Medicare & Medicaid Services (CMS) indicate a growing recognition of the agent’s clinical value, potentially facilitating favorable reimbursement codes.

4. Competitive Differentiation

While other tumor-targeting agents exist, pafolacianine sodium’s near-infrared fluorescence modality offers superior spatial resolution and real-time feedback. Its specificity for folate receptor-positive tumors distinguishes it from generic dyes, creating a competitive advantage in selected cancer types.

Market Barriers and Challenges

1. Limited Clinical Evidence and Adoption Lag

Although promising, widespread clinical data remains limited compared to established imaging agents. Slow adoption may occur due to clinician unfamiliarity, institutional inertia, or logistical challenges in integrating new imaging systems.

2. Manufacturing and Supply Chain Constraints

The production complexity of near-infrared agents necessitates stringent quality controls. Any disruptions could impede supply stability, impacting sales forecasts.

3. Competition from Alternative Technologies

Emerging therapies like molecular fluorescence imaging with other targeting antibodies or novel dyes could challenge pafolacianine sodium’s market share. Additionally, advancements in intraoperative imaging modalities, such as intraoperative MRI or PET, could shift preferences away from fluorescence agents.

4. Regulatory and Reimbursement Uncertainties

While initial approvals are promising, eventual challenges in expanding indications or gaining reimbursement for broader cancer types may slow revenue growth.

Financial Trajectory and Revenue Projections

Market Penetration and Sales Growth

Initial shipments post-FDA approval indicate cautious adoption, with early revenue estimates ranging from $10 to $20 million in the first year. Analysts project annual growth rates of 25-35% over the next five years as adoption broadens, contingent upon:

• Expansion into additional cancer indications (e.g., lung, breast)
• Increasing number of surgical centers adopting fluorescence-guided surgery
• Successful integration into clinical guidelines

Pricing Strategy and Revenue Model

Cytalux’s pricing has been set at approximately $1,200 per dose in the U.S., comparable to other intraoperative imaging agents [3]. As adoption scales, revenue potential hinges on reimbursement success and manufacturing efficiencies.

Long-Term Forecast

By 2030, with rapid market penetration and expanded indication labeling, global revenues could surpass $200 million annually. Strategic partnerships with surgical device manufacturers and regional distributors will influence market share distribution geographically.

Investment and R&D Outlook

Manufacturers are investing in next-generation folate receptor-targeted agents, potentially integrating pafolacianine sodium into multimodal diagnostic platforms. Continued R&D, coupled with clinical trial data demonstrating survival benefits, will bolster valuation and long-term revenue streams.

Strategic Considerations for Stakeholders

• Clinicians and Hospitals: Embracing pafolacacianine sodium necessitates training, investment in compatible imaging infrastructure, and inclusion in surgical protocols.
• Manufacturers: Ensuring supply chain robustness, expanding indications, and engaging payers are critical to scaling revenue.
• Investors: Early-stage adoption signals substantive growth, but regulatory and competitive risks warrant cautious optimism, balanced by the agent’s differentiating clinical benefits.

Key Takeaways

• Pafolacianine sodium occupies a niche within the growing intraoperative imaging market, driven by its targeted fluorescence capabilities.
• Its financial trajectory is poised for significant growth, forecasted to reach hundreds of millions in revenue globally by the late 2020s.
• Market expansion depends on increasing clinical adoption, expanding indications, overcoming logistical barriers, and securing reimbursement.
• Competitive pressures from alternative imaging technologies and emerging agents necessitate ongoing innovation and evidence generation.
• Strategic collaborations and focus on clinician education will be vital in converting trial successes into routine surgical standards.

FAQs

1. What are the primary clinical benefits of pafolacianine sodium?
Pafolacianine sodium enhances intraoperative tumor visualization, potentially increasing complete resection rates, reducing residual disease, and improving patient survival outcomes in cancers overexpressing folate receptors.

2. How does pafolacianine sodium compare to existing intraoperative imaging agents?
Its near-infrared fluorescence provides superior tissue penetration and real-time feedback, along with high specificity for folate receptor-positive tumors, surpassing traditional dyes like indocyanine green (ICG) in targeted applications.

3. What are the main hurdles facing pafolacianine sodium’s market expansion?
Barriers include limited clinical adoption due to insufficient long-term data, logistical challenges in integrating fluorescence imaging, manufacturing constraints, and evolving competitive landscape from alternative technologies.

4. How significant is reimbursement in shaping pafolacianine sodium’s financial trajectory?
Reimbursement is critical; favorable coding and coverage facilitate widespread adoption and revenue growth, whereas reimbursement delays could hinder market penetration.

5. What future developments could influence pafolacianine sodium’s market?
Potential advancements include FDA approval for additional cancer indications, improvements in imaging device compatibility, integration into surgical AI platforms, and accumulation of evidence demonstrating survival benefits.

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References

1. Global Cancer Incidence and Mortality, WHO, 2022.
2. Cancer Statistics, 2022, American Cancer Society.
3. Pricing and Reimbursement Data for Fluorescence Agents, MedTech Insight, 2022.