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

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			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
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
World Intellectual Property Organization (WIPO)	2014143309
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)
Australia	2013383382	Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Mexico	2015013223	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.)
World Intellectual Property Organization (WIPO)	2014149073