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
DailyMed Link:	pafolacianine sodium at DailyMed

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

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
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			Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes			Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes			Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes			Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes			Y	Y

International Patents for pafolacianine sodium

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1218257	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)
European Patent Office	2968335	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)
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
Israel	240828	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)
China	105228628	Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Canada	2902205	IMAGERIE PAR FLUORESCENCE DE MALADIES INFLAMMATOIRES (FLUORESCENCE IMAGING OF INFLAMMATORY DISEASES)
China	105120903	Methods of manufacture and synthesis of amino acid linking groups conjugated to compounds used for targeted imaging of tumors