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Last Updated: March 19, 2024

Nelarabine - Generic Drug Details


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Summary for nelarabine
US Patents:0
Tradenames:2
Applicants:8
NDAs:8
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 9
Raw Ingredient (Bulk) Api Vendors: 85
Clinical Trials: 28
Patent Applications: 6,139
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

SponsorPhase
Cancer Hospital of Henan ProvincePhase 3
Second Affiliated Hospital of Anhui Medical UniversityPhase 3
West China Second University HospitalPhase 3

See all nelarabine clinical trials

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
Zydus Pharms NELARABINE nelarabine INJECTABLE;INTRAVENOUS 215037-001 Nov 17, 2021 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal NELARABINE nelarabine INJECTABLE;INTRAVENOUS 216346-001 Apr 4, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz ARRANON nelarabine INJECTABLE;INTRAVENOUS 021877-001 Oct 28, 2005 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Kindos NELARABINE nelarabine INJECTABLE;INTRAVENOUS 216038-001 Jan 10, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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