Viewing data from:

ARRANON

NDA

NELARABINE | N021877 | SANDOZ INC

1 strength0 unique patents0 unique exclusivities

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-4730 The law firm Hyman, Phelps & McNamara submitted a suitability petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Nelarabine Injection 375 mg/75 mL (5 mg/mL) Single Dose Vials suitable for submission as an ANDA, with Sa	Suitability	2024-10-09	Open	Hyman

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Arranon (2023)

Total Spending

$374K

Total Claims

Beneficiaries

ASP Price

—

HCPCS: J9261 — Injection, nelarabine, 50 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain6 active DMFs1 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

SYNBIAS PHARMA AGNELARABINE

DMF 305752016

BIOPHORE INDIA PHARMACEUTICALS PVT LTDNELARABINE

DMF 350492020

CHEMWERTH INCNELARABINE

DMF 360812021

MSN LABORATORIES PRIVATE LTDNELARABINE

DMF 363052021

ALEMBIC PHARMACEUTICALS LTDNELARABINE

DMF 375442022

SCINOPHARM TAIWAN LTDNELARABINE

DMF 390302023

ALP PHARM BEIJING CO LTDInactiveNELARABINE

DMF 243762010

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Mar 13, 2025	SUPPL -14	View Letter (PDF)
Dec 16, 2022	SUPPL -12	View Letter (PDF)
Aug 1, 2019	SUPPL -10	View Letter (PDF)
Dec 20, 2018	SUPPL -9	View Letter (PDF)
Jul 6, 2018	SUPPL -8	View Letter (PDF)
Feb 7, 2012	SUPPL -5	View Letter (PDF)
Dec 24, 2009	SUPPL -1	View Letter (PDF)
Dec 24, 2009	SUPPL -2	View Letter (PDF)
Nov 1, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG/50ML (5MG/ML)

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Oct 28, 2005

No patent or exclusivity listings for this strength.