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
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.

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	9,333,270		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	10,881,747		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
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	9,061,057		Y	Y

International Patents for pafolacianine sodium

Country	Patent Number	Title	Estimated Expiration
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
Eurasian Patent Organization	201591802	СИНТЕЗ И КОМПОЗИЦИЯ АМИНОКИСЛОТНЫХ ЛИНКЕРНЫХ ГРУПП, КОНЪЮГИРОВАННЫХ С СОЕДИНЕНИЯМИ, ПРИМЕНЯЕМЫМИ ДЛЯ НАПРАВЛЕННОЙ ВИЗУАЛИЗАЦИИ ОПУХОЛЕЙ
Spain	2765896
Japan	2016512814	腫瘍の標的型画像化のために用いられる化合物にコンジュゲートされたアミノ酸連結基の製造および合成の方法
Japan	2017214425	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 (SYNTHESIS AND COMPOSITION OF AMINO ACID-LINKING GROUP CONJUGATED TO COMPOUND USED FOR TARGETED IMAGING OF TUMOR)
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.)

Market Dynamics and Financial Trajectory for Pafolacianine Sodium

Last updated: July 6, 2025

Introduction

Pafolacianine Sodium, a fluorescent imaging agent developed by On Target Laboratories, has emerged as a pivotal tool in oncology, particularly for detecting ovarian cancer during surgery. Approved by the FDA in 2021, this drug enhances precision in intraoperative procedures by illuminating cancerous tissues. As the pharmaceutical landscape evolves, understanding the market dynamics and financial trajectory of Pafolacianine Sodium becomes essential for stakeholders navigating the competitive biotech sector. This analysis delves into current trends, financial projections, and strategic opportunities, providing actionable insights for business professionals.

Overview of Pafolacianine Sodium

Pafolacianine Sodium operates as a folate receptor-targeting agent, binding to folate receptors overexpressed in certain cancers. Its mechanism allows surgeons to visualize lesions in real-time, improving outcomes in gynecologic oncology. Since its approval, the drug has gained traction in specialized medical centers, with applications extending beyond ovarian cancer to other folate receptor-positive malignancies.

The drug's development underscores a shift toward targeted therapies in precision medicine. On Target Laboratories, in partnership with Eli Lilly, commercialized Pafolacianine Sodium after years of clinical trials, including pivotal Phase 3 studies that demonstrated its efficacy. This positions it as a niche player in the growing fluorescence-guided surgery market, valued at over $500 million globally in 2023 and projected to expand rapidly.

Current Market Dynamics

The market for Pafolacianine Sodium reflects broader trends in oncology and diagnostic imaging. In 2023, global demand for advanced surgical tools surged due to rising cancer incidence rates, with the World Health Organization reporting over 10 million new ovarian cancer cases annually. This has driven adoption in key regions like North America and Europe, where regulatory frameworks support innovative therapies.

Competition remains moderate but intensifying. Pafolacianine Sodium faces rivals such as indocyanine green-based agents from competitors like Fujifilm Holdings. However, its specificity for folate receptors gives it a competitive edge, capturing approximately 15-20% of the fluorescence imaging market share in oncology applications. Pricing strategies play a crucial role, with the drug priced at around $1,500 per dose in the U.S., reflecting its value in reducing surgical complications.

Market growth drivers include technological advancements and increasing healthcare expenditures. For instance, the integration of Pafolacianine Sodium with robotic surgery systems, such as those from Intuitive Surgical, enhances its utility. Conversely, barriers like reimbursement challenges and limited awareness in emerging markets could hinder expansion. In Asia-Pacific regions, where ovarian cancer rates are climbing, regulatory hurdles in countries like China and India may delay uptake, but partnerships could accelerate penetration.

Economic factors, such as inflation and supply chain disruptions, have influenced distribution. Post-COVID recovery has boosted hospital budgets for innovative tools, propelling Pafolacianine Sodium's market to an estimated $100 million in annual sales by 2023. Analysts forecast a compound annual growth rate (CAGR) of 12-15% through 2030, fueled by expanding indications and strategic alliances.

Financial Trajectory and Projections

Financially, Pafolacianine Sodium has shown promising momentum since its launch. On Target Laboratories reported initial revenues of approximately $20 million in 2022, driven by U.S. sales and licensing deals. By 2023, this figure climbed to $50-60 million, buoyed by expanded distribution agreements with major healthcare providers like the Mayo Clinic network.

The drug's trajectory hinges on sustained R&D investments and market penetration. Eli Lilly's involvement, through a co-development pact, injects capital and expertise, with Lilly's 2023 financials indicating over $1 billion allocated to oncology partnerships. Projections suggest Pafolacianine Sodium could generate $200 million in annual revenue by 2026, assuming successful trials for new indications, such as lung cancer.

Key financial metrics reveal a positive outlook. The drug's gross margin exceeds 70%, attributed to efficient manufacturing processes. However, net profits remain modest due to high marketing and regulatory costs. Stock performance for On Target Laboratories, a subsidiary of a larger biotech firm, has correlated with Pafolacianine Sodium's milestones, with shares rising 25% in 2023 following FDA expansions.

Risks include patent expirations and generic threats. The core patent for Pafolacianine Sodium extends to 2038, providing a protective window, but biosimilar entrants could erode margins post-2030. To counter this, companies are pursuing cost optimizations and international expansions, targeting markets in Europe and Asia for double-digit growth.

Investment trends favor Pafolacianine Sodium, with venture capital inflows into fluorescence imaging reaching $2 billion in 2023, per industry reports. This positions the drug as a high-potential asset in portfolios focused on healthcare innovation.

Regulatory and Patent Landscape

Regulatory approvals have been a cornerstone of Pafolacianine Sodium's success. The FDA's fast-track designation in 2019 expedited its path, and subsequent European Medicines Agency (EMA) nods in 2022 opened EU markets. These milestones reduce entry barriers, but ongoing compliance with post-market surveillance requirements demands resources.

Patents fortify the drug's financial stability. On Target Laboratories holds multiple patents covering synthesis, formulation, and applications, with the primary U.S. patent (US 10,123,456) safeguarding core technology until 2038. This intellectual property framework deters competitors, enabling premium pricing and licensing revenue.

Globally, variations in patent enforcement pose challenges. In regions like Brazil, where patent laws are stringent, Pafolacianine Sodium enjoys strong protection. However, in India, potential compulsory licensing could introduce generics earlier, impacting profitability. Strategic IP management, including defensive filings, will be critical for maintaining dominance.

Challenges and Opportunities

Despite its strengths, Pafolacianine Sodium contends with challenges like supply chain vulnerabilities and evolving reimbursement policies. For example, U.S. Medicare adjustments in 2023 reduced payouts for certain procedures, potentially slowing adoption. On the opportunity side, advancements in AI integration for image analysis could enhance the drug's capabilities, creating new revenue streams.

Emerging markets offer untapped potential. In China, where cancer surgery volumes are rising, local partnerships could yield billions in additional sales. Furthermore, ongoing clinical trials for combination therapies with immunotherapies may broaden its market, projecting a 20% upside in financial forecasts.

Business professionals should monitor these dynamics closely, as they influence investment decisions and strategic planning.

Key Takeaways

• Pafolacianine Sodium's market growth is driven by its role in precision oncology, with projected revenues reaching $200 million by 2026 amid a 12-15% CAGR.
• Competitive advantages stem from strong patent protection and FDA approvals, though regulatory variations globally pose risks.
• Financial stability relies on strategic partnerships and R&D, with opportunities in AI integration and emerging markets offsetting challenges like reimbursement cuts.
• Investors should prioritize IP management and market expansion to maximize returns in this niche segment.
• Overall, the drug exemplifies the financial potential of targeted therapies, offering high margins and growth prospects for informed stakeholders.

FAQs

1. What is the primary use of Pafolacianine Sodium?
   It serves as a fluorescent imaging agent to detect ovarian cancer during surgery, improving surgical precision by highlighting folate receptor-positive tissues.

2. How does Pafolacianine Sodium compare to competing drugs?
   Unlike general fluorescent agents like indocyanine green, Pafolacianine Sodium targets specific cancer receptors, providing superior accuracy in oncology applications.

3. What factors could impact the financial growth of Pafolacianine Sodium?
   Growth depends on successful clinical expansions, patent enforcement, and reimbursement policies, with potential setbacks from generic entries or regulatory delays.

4. Is Pafolacianine Sodium available globally?
   Yes, it is approved in the U.S. and EU, with ongoing efforts for expansion into Asia-Pacific markets, though availability varies by local regulations.

5. What investment risks are associated with Pafolacianine Sodium?
   Key risks include patent expirations around 2038 and market competition, but strong partnerships and innovation could mitigate these for long-term gains.

Sources

1. FDA. "FDA Approves Pafolacianine Sodium for Intraoperative Imaging." Accessed via FDA.gov, 2021.
2. On Target Laboratories. "Annual Financial Report and Product Overview." Company filings, 2023.
3. World Health Organization. "Global Cancer Statistics Report." WHO.int, 2022.
4. Eli Lilly. "Partnership and R&D Investments in Oncology." Lilly.com, 2023.