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IWILFIN

NDA

EFLORNITHINE HYDROCHLORIDE | N215500 | USWM LLC

1 strength1 unique patent2 unique exclusivities

Patent Timeline

1 unique patent, 2 exclusivities by expiration date

Active (1)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

12582625

Feb. 12, 2036

Dec. 13, 2026

ODE-462

Dec. 13, 2030

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

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SCINOPHARM TAIWAN LTDEFLORNITHINE HYDROCHLORIDE

DMF 185092005

RUSAN PHARMA LTDEFLORNITHINE HYDROCHLORIDE MONOHYDRATE

DMF 317802017

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Nov 29, 2024	SUPPL -1	View Letter (PDF)
Dec 14, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 192MG BASE

RLD

1 patent2 exclusivities▴

TABLET;ORAL | Approved: Dec 13, 2023

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
12582625	Feb 12, 2036	—	—	—	U-4444	—

Exclusivities (2)

Code	Date	Status
NP	Dec 13, 2026	< 1 year
ODE-462	Dec 13, 2030	Active