Orange Book product · Brand (NDA)

CYTALUX

PAFOLACIANINE SODIUM

Brand (NDA)NDA 214907RX ON TARGET LABS

Nov 29, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 29, 2021
4 yr 7 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Nov 29, 2026
in 5 mo
Exclusivity ends · ODE-390
Orphan-drug exclusivity (7 years)
Nov 29, 2028
in 2 yr 6 mo
Patent 10881747 expires
Listed drug substance patent expiration.
Aug 26, 2033
in 7 yr 4 mo
Patent 9333270 expires
Listed drug substance patent expiration.
Aug 26, 2033
in 7 yr 4 mo
Patent 9341629 expires
Listed drug substance patent expiration.
Aug 26, 2033
in 7 yr 4 mo
Patent 9789208 expires
Listed drug substance patent expiration.
Aug 26, 2033
in 7 yr 4 mo
Patent 9254341 expires
Listed drug substance patent expiration.
Oct 04, 2033
in 7 yr 5 mo
Patent 9061057 expires
Listed drug substance patent expiration.
Nov 29, 2035
in 9 yr 7 mo

Active ingredient

PAFOLACIANINE SODIUM

Strength

EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 214907

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10881747	Aug 26, 2033	in 7 yr 4 mo	SubstanceProductU-3291
9333270	Aug 26, 2033	in 7 yr 4 mo	SubstanceProductU-3291
9341629	Aug 26, 2033	in 7 yr 4 mo	SubstanceProduct
9789208	Aug 26, 2033	in 7 yr 4 mo	SubstanceProductU-3291
9254341	Oct 04, 2033	in 7 yr 5 mo	SubstanceProduct
9061057	Nov 29, 2035	in 9 yr 7 mo	SubstanceProductU-3291