NELARABINE Drug Patent Profile
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Which patents cover Nelarabine, and when can generic versions of Nelarabine launch?
Nelarabine is a drug marketed by Alembic, Amneal, Dr Reddys, Gland Pharma Ltd, Meitheal, MSN, Nexus, Shorla, Xgen Pharms, and Zydus Pharms. and is included in ten NDAs.
The generic ingredient in NELARABINE is nelarabine. There are two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the nelarabine profile page.
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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Questions you can ask:
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Summary for NELARABINE
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 10 |
| Finished Product Suppliers / Packagers: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 85 |
| Clinical Trials: | 30 |
| Patent Applications: | 4,292 |
| 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 |
| Qilu Hospital of Shandong University | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
