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CYTALUX Drug Patent Profile

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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

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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

Drug patent expirations by year for CYTALUX

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

Generic Entry Date for CYTALUX^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CYTALUX is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting CYTALUX

Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: CYTALUX IS AN OPTICAL IMAGING AGENT INDICATED IN ADULT PATIENTS WITH OVARIAN CANCER AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS

Methods of manufacture of pteroyl-amino acid-fluorescent dyes
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting CYTALUX

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT AND NONMALIGNANT PULMONARY LESIONS IN ADULT PATIENTS WITH KNOWN OR SUSPECTED CANCER IN THE LUNG
Exclusivity Expiration: ⤷ Sign Up

AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS IN ADULT PATIENTS WITH OVARIAN CANCER
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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

Patent: 13381391
Patent: Fluorescence imaging of inflammatory diseases
Estimated Expiration: ⤷ Sign Up

Patent: 13383382
Patent: Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Estimated Expiration: ⤷ Sign Up

Patent: 13383386
Patent: Methods of manufacture and synthesis of amino acid linking groups conjugated to compounds used for targeted imaging of tumors
Estimated Expiration: ⤷ Sign Up

Patent: 17203340
Patent: Synthesis And Composition Of Amino Acid Linking Groups Conjugated To Compounds Used For The Targeted Imaging Of Tumors
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2015022810
Patent: síntese e composição de grupos de ligação de aminoácidos conjugados a compostos utilizados para a criação de imagens específicas de tumores
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 02205
Patent: IMAGERIE PAR FLUORESCENCE DE MALADIES INFLAMMATOIRES (FLUORESCENCE IMAGING OF INFLAMMATORY DISEASES)
Estimated Expiration: ⤷ Sign Up

Patent: 03727
Patent: PROCEDES DE FABRICATION ET DE SYNTHESE DE GROUPES DE LIAISON D'ACIDE AMINE CONJUGUES A DES COMPOSES UTILISES POUR L'IMAGERIE CIBLEE DE TUMEURS (METHODS OF MANUFACTURE AND SYNTHESIS OF AMINO ACID LINKING GROUPS CONJUGATED TO COMPOUNDS USED FOR TARGETED IMAGING OF TUMORS)
Estimated Expiration: ⤷ Sign Up

Patent: 03994
Patent: SYNTHESE ET COMPOSITION DE GROUPES DE LIAISON D'ACIDES AMINES CONJUGUES A DES COMPOSES UTILISES POUR L'IMAGERIE CIBLEE DE TUMEURS (SYNTHESIS AND COMPOSITION OF AMINO ACID LINKING GROUPS CONJUGATED TO COMPOUNDS USED FOR THE TARGETED IMAGING OF TUMORS)
Estimated Expiration: ⤷ Sign Up

China

Patent: 5120903
Patent: Methods of manufacture and synthesis of amino acid linking groups conjugated to compounds used for targeted imaging of tumors
Estimated Expiration: ⤷ Sign Up

Patent: 5228628
Patent: Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Estimated Expiration: ⤷ Sign Up

Patent: 5492905
Patent: Fluorescence imaging of inflammatory diseases
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 9738
Patent: 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)
Estimated Expiration: ⤷ Sign Up

Patent: 1591802
Patent: СИНТЕЗ И КОМПОЗИЦИЯ АМИНОКИСЛОТНЫХ ЛИНКЕРНЫХ ГРУПП, КОНЪЮГИРОВАННЫХ С СОЕДИНЕНИЯМИ, ПРИМЕНЯЕМЫМИ ДЛЯ НАПРАВЛЕННОЙ ВИЗУАЛИЗАЦИИ ОПУХОЛЕЙ
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 68335
Patent: SYNTHÈSE ET COMPOSITION DE GROUPES DE LIAISON D'ACIDES AMINÉS CONJUGUÉS À DES COMPOSÉS UTILISÉS POUR L'IMAGERIE CIBLÉE DE TUMEURS (SYNTHESIS AND COMPOSITION OF AMINO ACID LINKING GROUPS CONJUGATED TO COMPOUNDS USED FOR THE TARGETED IMAGING OF TUMORS)
Estimated Expiration: ⤷ Sign Up

Patent: 68614
Patent: PROCÉDÉS DE FABRICATION ET DE SYNTHÈSE DE GROUPES DE LIAISON D'ACIDE AMINÉ CONJUGUÉS À DES COMPOSÉS UTILISÉS POUR L'IMAGERIE CIBLÉE DE TUMEURS (METHODS OF MANUFACTURE AND SYNTHESIS OF AMINO ACID LINKING GROUPS CONJUGATED TO COMPOUNDS USED FOR TARGETED IMAGING OF TUMORS)
Estimated Expiration: ⤷ Sign Up

Patent: 72320
Patent: IMAGERIE PAR FLUORESCENCE DE MALADIES INFLAMMATOIRES (METHODS OF IMAGING INFLAMMATORY DISEASES BY LIGANDS CONJUGATED TO FLUORESCENT COMPOUNDS)
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 18257
Patent: 用於使腫瘤靶向成像的化合物綴合的氨基酸連接基的製備和合成方法 (METHODS OF MANUFACTURE AND SYNTHESIS OF AMINO ACID LINKING GROUPS CONJUGATED TO COMPOUNDS USED FOR TARGETED IMAGING OF TUMORS)
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 0509
Patent: דימות פלואורסנטי של מחלות דלקתיות (Fluorescence imaging of inflammatory diseases)
Estimated Expiration: ⤷ Sign Up

Patent: 0673
Patent: 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)
Estimated Expiration: ⤷ Sign Up

Patent: 0828
Patent: שיטות לייצור וסינתזה של קבוצות קושרות חומצת אמינו מצומדות לתרכובות המשמשות להדמיה ממוקדת של גידולים (Methods of manufacture and synthesis of amino acid linking groups conjugated to compounds used for targeted imaging of tumors)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 92799
Estimated Expiration: ⤷ Sign Up

Patent: 70981
Estimated Expiration: ⤷ Sign Up

Patent: 16512240
Patent: 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
Estimated Expiration: ⤷ Sign Up

Patent: 16512813
Patent: 腫瘍の標的画像化に使用される化合物にコンジュゲートしているアミノ酸連結基の合成および組成物
Estimated Expiration: ⤷ Sign Up

Patent: 16512814
Patent: 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
Estimated Expiration: ⤷ Sign Up

Patent: 17149776
Patent: 腫瘍の標的画像化に使用される化合物にコンジュゲートしているアミノ酸連結基の合成および組成物 (SYNTHESIS AND COMPOSITION OF AMINO ACID LINKING GROUP CONJUGATED TO COMPOUND USED FOR THE TARGETED IMAGING OF TUMOR)
Estimated Expiration: ⤷ Sign Up

Patent: 17214425
Patent: 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)
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 8184
Patent: 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.)
Estimated Expiration: ⤷ Sign Up

Patent: 15011830
Patent: 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.)
Estimated Expiration: ⤷ Sign Up

Patent: 15013219
Patent: IMAGENOLOGIA POR FLUORESCENCIA DE ENFERMEDADES INFLAMATORIAS. (FLUORESCENCE IMAGING OF INFLAMMATORY DISEASES.)
Estimated Expiration: ⤷ Sign Up

Patent: 15013223
Patent: 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.)
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 65896
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2014143309		⤷ Sign Up
Japan	2017149776	腫瘍の標的画像化に使用される化合物にコンジュゲートしているアミノ酸連結基の合成および組成物 (SYNTHESIS AND COMPOSITION OF AMINO ACID LINKING GROUP CONJUGATED TO COMPOUND USED FOR THE TARGETED IMAGING OF TUMOR)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2014149069		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration