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CYTALUX

NDA

PAFOLACIANINE SODIUM | N214907 | ON TARGET LABORATORIES INC

1 strength6 unique patents2 unique exclusivities

Patent Timeline

6 unique patents, 2 exclusivities by expiration date

Active (6)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Nov. 29, 2035

Oct. 4, 2033

Aug. 26, 2033

Aug. 26, 2033

Aug. 26, 2033

Aug. 26, 2033

NCE

Nov. 29, 2026

ODE-390

Nov. 29, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 20, 2022	SUPPL -2	View Letter (PDF)
Nov 30, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)

RLD

6 patents2 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Nov 29, 2021

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9061057	Nov 29, 2035	—	Yes	Yes		—
9254341	Oct 4, 2033	—	Yes	Yes	—	—
9333270	Aug 26, 2033	—	Yes	Yes		—
9341629	Aug 26, 2033	—	Yes	Yes	—	—
9789208	Aug 26, 2033	—	Yes	Yes		—
10881747	Aug 26, 2033	—	Yes	Yes		—

Exclusivities (2)

Code	Date	Status
NCE	Nov 29, 2026	< 1 year
ODE-390	Nov 29, 2028	Active

Change History (1)

Recent changes detected for this application.

MODIFIEDPatent Expiration7/1/2026

Orange Book patent for pafolacianine sodium (CYTALUX) listed patent 9,061,057 extended from Aug 2033 to Nov 2035.

Old: Aug 26, 2033

New: Nov 29, 2035