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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.

This drug has thirty-five patent family members in twelve countries.

The generic ingredient in CYTALUX is pafolacianine sodium. One supplier is listed for this compound. Additional details are available on the pafolacianine sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Cytalux

Cytalux will be eligible for patent challenges on November 29, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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

International Patents:	35
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in CYTALUX?	CYTALUX excipients list
DailyMed Link:	CYTALUX at DailyMed

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

Constraining patent/regulatory exclusivity:

9,341,629

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.

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 three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,341,629.

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	9,333,270		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	9,789,208		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
Eurasian Patent Organization	029738	СИНТЕЗ И КОМПОЗИЦИЯ АМИНОКИСЛОТНЫХ ЛИНКЕРНЫХ ГРУПП, КОНЪЮГИРОВАННЫХ С СОЕДИНЕНИЯМИ, ПРИМЕНЯЕМЫМИ ДЛЯ НАПРАВЛЕННОЙ ВИЗУАЛИЗАЦИИ ОПУХОЛЕЙ (SYNTHESIS AND COMPOSITION OF AMINO ACID LINKING GROUPS CONJUGATED TO COMPOUNDS USED FOR THE TARGETED IMAGING OF TUMORS)
Israel	240673	סינתזה והרכב של קבוצות קושרות חומצות אמינו מצומדות לתרכובות המשמשות להדמיה ממוקדת של גידולים (Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors)
China	105120903	Methods of manufacture and synthesis of amino acid linking groups conjugated to compounds used for targeted imaging of tumors

CYTALUX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CYTALUX

Introduction to CYTALUX

CYTALUX, developed by On Target Laboratories, is a groundbreaking molecular imaging agent that illuminates lung and ovarian cancer during surgery, enabling surgeons to detect and remove cancerous tissue more effectively. Here, we delve into the market dynamics and financial trajectory of this innovative drug.

FDA Approval and Regulatory Milestones

CYTALUX received FDA approval for ovarian cancer in November 2021 and a supplemental approval for lung cancer in December 2022. These approvals were crucial in establishing the drug's legitimacy and paving the way for its commercialization[1][4].

Funding and Investment

On Target Laboratories secured a significant $30 million Series C financing round in November 2023, backed by prominent investors such as H.I.G. Capital, The Hurvis Group, Johnson & Johnson Innovation – JJDC, Inc., and others. This funding is critical for accelerating the commercial launch and expanding the market presence of CYTALUX[1][5].

Commercialization and Market Expansion

The recent funding will enable On Target Laboratories to expedite the commercial launch of CYTALUX, making it more accessible to patients and healthcare providers across the United States. The company aims to amplify its market presence, leveraging the support from both private equity and strategic investors[1].

Reimbursement and Access

In August 2023, the Centers for Medicare & Medicaid Services (CMS) granted a new technology add-on payment (NTAP) for CYTALUX use in ovarian and lung cancer surgery. This NTAP allows CMS to provide hospitals with additional payment of up to 65% of the average cost of CYTALUX, significantly expanding access to the technology[1].

Technological Integration

The commercialization of CYTALUX is further enhanced by its compatibility with advanced surgical equipment. For instance, Stryker's 1788 Platform, the only minimally invasive surgical camera cleared for use with CYTALUX, was recently introduced. This convergence of financing, reimbursement, and technological integration creates a unique opportunity for On Target to expedite the expansion of CYTALUX[1].

Clinical Impact and Outcomes

CYTALUX has demonstrated impressive clinical outcomes in trials. Surgeons have reported the ability to see the borders of tumors in real time, allowing for more precise removal of cancerous tissue while preserving unaffected organ tissue. This has led to the removal of cancers that would have been missed without CYTALUX, as they were not visible on scans[4].

Market Reception and Adoption

The market reception of CYTALUX has been positive, with surgeons and healthcare providers recognizing its value in improving surgical outcomes. The drug's ability to illuminate even the tiniest tumors has been hailed as a game-changer in surgical imaging. This positive reception is expected to drive adoption and increase market share[1][4].

Financial Performance and Projections

While specific financial projections for CYTALUX are not detailed, the significant investment and reimbursement support indicate a strong financial trajectory. The $30 million Series C financing and the NTAP from CMS are expected to contribute substantially to the company's revenue growth. Additionally, the commercial launch in September 2023 marked the beginning of a new phase in generating revenue from CYTALUX sales[1][5].

Competitive Landscape

In the field of cancer imaging and treatment, CYTALUX stands out due to its unique ability to illuminate cancerous tissue during surgery. However, it operates in a competitive landscape where other biotechnology companies are also advancing innovative cancer treatments. For example, companies like CatalYm and ImmunoGen are developing novel therapies targeting different aspects of cancer treatment, but CYTALUX's specific application in surgical imaging sets it apart[2][3].

Strategic Partnerships and Collaborations

On Target Laboratories has benefited from strategic partnerships and collaborations, including participation in the NCI-sponsored SBIR Investor Initiatives. These initiatives helped the company secure additional funding and support from investors and strategic partners, further solidifying its position in the market[4].

Future Outlook

The future outlook for CYTALUX is promising, driven by its clinical efficacy, regulatory approvals, and strong financial backing. As the company continues to expand its market presence and integrate its technology with advanced surgical tools, it is poised to become a leading solution in intraoperative molecular imaging.

"The ability of CYTALUX to illuminate lung and ovarian cancer during surgery is a stellar example of what we describe at Olympus as 'making the invisible visible'" - Nacho Abia, Chief Strategy Officer at Olympus[1].

Key Takeaways

• FDA Approvals: CYTALUX received FDA approvals for ovarian and lung cancer, marking significant regulatory milestones.
• Funding: Secured $30 million Series C financing to accelerate commercialization.
• Reimbursement: CMS granted NTAP, expanding access to the technology.
• Technological Integration: Compatible with advanced surgical equipment like Stryker's 1788 Platform.
• Clinical Impact: Demonstrated ability to improve surgical outcomes by illuminating cancerous tissue.
• Market Reception: Positive reception from surgeons and healthcare providers.
• Financial Trajectory: Strong financial outlook driven by investment and reimbursement support.

FAQs

What is CYTALUX used for?

CYTALUX is a molecular imaging agent used to illuminate lung and ovarian cancer during surgery, helping surgeons detect and remove cancerous tissue more effectively.

When did CYTALUX receive FDA approval?

CYTALUX received FDA approval for ovarian cancer in November 2021 and a supplemental approval for lung cancer in December 2022.

How is CYTALUX administered?

CYTALUX is administered via a single dose intravenous infusion prior to surgery.

What is the significance of the NTAP for CYTALUX?

The NTAP granted by CMS allows hospitals to receive additional payment of up to 65% of the average cost of CYTALUX, expanding access to the technology.

What is the role of strategic partnerships in CYTALUX's development?

Strategic partnerships, such as those facilitated by the NCI-sponsored SBIR Investor Initiatives, have been crucial in securing funding and support for the development and commercialization of CYTALUX.

Sources

1. On Target Laboratories Secures $30 Million for Commercialization of CYTALUX (pafolacianine) Injection - PR Newswire
2. CatalYm Announces New Financing of $150M to Support Broad Phase 2b Development Program for Visugromab - Brandon BioCatalyst
3. ImmunoGen is now part of AbbVie - ImmunoGen Investor Relations
4. Lighting the Way to Detect Tumors During Surgery - National Cancer Institute
5. On Target Laboratories Secures $30 Million for Commercialization of CYTALUX (pafolacianine) Injection - Johnson & Johnson Innovation