NELARABINE - Generic Drug Details

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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
Sun Yat-Sen Memorial Hospital Zhongshan 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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msn	NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	216948-001	Sep 13, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	215037-001	Nov 17, 2021	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland Pharma Ltd	NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	212605-001	Jan 3, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for NELARABINE

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

EU/EMA Drug Approvals for NELARABINE

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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