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Details for Generic Name: nelarabine

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Nelarabine is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-three patent family members in twenty-eight countries.

There is one drug master file entry for nelarabine. One supplier is listed for this compound.

Summary for Generic Name: nelarabine

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: see list1
Suppliers: see list1

Pharmacology for Ingredient: nelarabine

Clinical Trials for: nelarabine

Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL
Status: Recruiting Condition: Relapsed T-Cell Acute Lymphoblastic Leukemia; Relapsed T-Cell Lymphoblastic Lymphoma

Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Nelarabine in Patients With Relapsed/Refractory Lymphoid Malignancies
Status: Recruiting Condition: Leukemia

Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma
Status: Completed Condition: Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic; Lymphoblastic Lymphoma; Acute Lymphoblastic Leukemia

Hyper-CVAD Plus Nelarabine in Untreated T-ALL/Lymphoblastic Lymphoma
Status: Recruiting Condition: Leukemia; Lymphoblastic Lymphoma; Leukemia, Lymphoblastic, Acute

Observational Study of Nelarabine in Children and Young Adults
Status: Completed Condition: Leukaemia, Lymphoblastic, Acute

Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg
Status: Active, not recruiting Condition: Cancer

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Status: Active, not recruiting Condition: Adult T Acute Lymphoblastic Leukemia; Childhood T Acute Lymphoblastic Leukemia; Stage II Adult T-Cell Leukemia/Lymphoma; Stage II Childhood Lymphoblastic Lymphoma; Stage II Contiguous Adult Lymphoblastic Lymphoma; Stage II Non-Contiguous Adult Lymphoblastic Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Stage III Adult T-Cell Leukemia/Lymphoma; Stage III Childhood Lymphoblastic Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Adult T-Cell Leukemia/Lymphoma; Stage IV Childhood Lymphoblastic Lymphoma; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia

506U78 in Treating Patients With Lymphoma
Status: Completed Condition: Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Small Intestine Lymphoma; Stage I Cutaneous T-cell Non-Hodgkin Lymphoma; Stage I Mycosis Fungoides/Sezary Syndrome; Stage II Cutaneous T-cell Non-Hodgkin Lymphoma; Stage II Mycosis Fungoides/Sezary Syndrome; Stage III Cutaneous T-cell Non-Hodgkin Lymphoma; Stage III Mycosis Fungoides/Sezary Syndrome; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IV Mycosis Fungoides/Sezary Syndrome

506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma
Status: Terminated Condition: Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome

506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)
Status: Completed Condition: T-ALL, T-NHL (Lymphoblastic)

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
ARRANON
nelarabine
INJECTABLE;IV (INFUSION)021877-001Oct 28, 2005RXYes5,424,295<disabled>YY<disabled>
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Non-Orange Book Patents for Generic Ingredient: nelarabine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,539,098 5'-O-propionyl and 5'-O-butyryl esters of 2-amino-6-methoxy-9-(.beta.-D-arabinofuranosyl)-9H-purine<disabled in preview>
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International Patent Family for Ingredient: nelarabine

Country Document Number Publication Date
Poland157684Jun 30, 1992
Norway882357May 27, 1988
South Africa8907598Jan 31, 1990
Hungary895829Jan 28, 1990
JapanS63310831Dec 19, 1988
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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