Nelarabine - Generic Drug Details
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What are the generic 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 |
Beijing Children's Hospital | Phase 3 |
Pharmacology for nelarabine
Drug Class | Nucleoside Metabolic Inhibitor |
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 | ⤷ 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 | |||
Shorla | NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 214809-001 | Mar 3, 2023 | 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
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 |
>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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