NELARABINE - Generic Drug Details

What are the generic drug sources for nelarabine and what is the scope of freedom to operate?

Nelarabine is the generic ingredient in two branded drugs marketed by Sandoz, Alembic, Amneal, Dr Reddys, Gland Pharma Ltd, Meitheal, MSN, Nexus, Shorla, Xgen Pharms, and Zydus Pharms, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for nelarabine. Thirteen suppliers are listed for this compound.

Summary for NELARABINE

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	30
Patent Applications:	5,608
What excipients (inactive ingredients) are in NELARABINE?	NELARABINE excipients list
DailyMed Link:	NELARABINE at DailyMed

Recent Clinical Trials for NELARABINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
CellSight Technologies, Inc.	Phase 2
University of Iowa Hospitals & Clinics	Phase 2
Xiangya Hospital of Central South University	Phase 3

See all NELARABINE clinical trials

Pharmacology for NELARABINE

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for NELARABINE

L01BB	Purine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for NELARABINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	215037-001	Nov 17, 2021	AP	RX	No	No
Dr Reddys	NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	216934-001	Dec 23, 2022	AP	RX	No	No
Shorla	NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	214809-001	Mar 3, 2023	AP	RX	No	No
Meitheal	NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	216038-001	Jan 10, 2023	AP	RX	No	No
Alembic	NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	218554-001	Aug 1, 2024	AP	RX	No	No
Xgen Pharms	NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	216510-001	Sep 5, 2024	AP	RX	No	No
Amneal	NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	216346-001	Apr 4, 2023	AP	RX	No	No

Expired US Patents for NELARABINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005

EU/EMA Drug Approvals for NELARABINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sandoz Pharmaceuticals d.d.	Atriance	nelarabine	EMEA/H/C/000752 Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens., , Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.,	Authorised	no	no	no	2007-08-22