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
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

International Patents for PAFOLACIANINE SODIUM

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2968614	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)
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
Japan	6270981
Brazil	112015022810	síntese e composição de grupos de ligação de aminoácidos conjugados a compostos utilizados para a criação de imagens específicas de tumores