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Last Updated: November 4, 2024

NELARABINE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Nelarabine

A generic version of NELARABINE was approved as nelarabine by ZYDUS PHARMS on November 17th, 2021.

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Drug patent expirations by year for NELARABINE
Recent Clinical Trials for NELARABINE

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SponsorPhase
CellSight Technologies, Inc.Phase 2
University of Iowa Hospitals & ClinicsPhase 2
Beijing Children's HospitalPhase 3

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Pharmacology for NELARABINE

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
Alembic NELARABINE nelarabine INJECTABLE;INTRAVENOUS 218554-001 Aug 1, 2024 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Nexus NELARABINE nelarabine INJECTABLE;INTRAVENOUS 215057-001 Jun 2, 2023 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
Shorla NELARABINE nelarabine INJECTABLE;INTRAVENOUS 214809-001 Mar 3, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal NELARABINE nelarabine INJECTABLE;INTRAVENOUS 216346-001 Apr 4, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys NELARABINE nelarabine INJECTABLE;INTRAVENOUS 216934-001 Dec 23, 2022 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msn NELARABINE nelarabine INJECTABLE;INTRAVENOUS 216948-001 Sep 13, 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

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

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