NELARABINE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Nelarabine, and when can generic versions of Nelarabine launch?
Nelarabine is a drug marketed by Amneal, Dr Reddys, Gland Pharma Ltd, Kindos, Nexus, Shorla, and Zydus Pharms. and is included in seven NDAs.
The generic ingredient in NELARABINE is nelarabine. There are two drug master file entries for this compound. Nine 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.
Summary for NELARABINE
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 85 |
| Clinical Trials: | 28 |
| Patent Applications: | 4,598 |
| DailyMed Link: | NELARABINE at DailyMed |
Recent Clinical Trials for NELARABINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Qilu Children's Hospital | Phase 3 |
| The First Affiliated Hospital of Zhengzhou University | Phase 3 |
| Children's Hospital of Hebei Province | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 216346-001 | Apr 4, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Pharms | NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 215037-001 | Nov 17, 2021 | AP | RX | No | No | ⤷ 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 | |||
| Dr Reddys | NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 216934-001 | Dec 23, 2022 | 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 |
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 |
