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Profile for Tradename: ARRANON

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Arranon is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There is one patent protecting this drug.

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

The generic ingredient in ARRANON is nelarabine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the nelarabine profile page.

Summary for Tradename: ARRANON

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: ARRANON

Clinical Trials for: ARRANON

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

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

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

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 Treating Patients With Refractory Hematologic Cancer
Status: Completed Condition: Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Lymphoblastic Lymphoma; T-cell Childhood Acute Lymphoblastic Leukemia

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

506U78 in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or T-cell Lymphoma
Status: Terminated Condition: Angioimmunoblastic T-cell Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Nodal Marginal Zone B-cell Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Small Lymphocytic Lymphoma; Splenic Marginal Zone Lymphoma; Waldenström Macroglobulinemia

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 Tradename: ARRANON

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 Tradename: ARRANON

Country Document Number Publication Date
Norway172543Apr 26, 1993
Germany3855522Oct 17, 1996
Canada1330990Jul 26, 1994
Germany122008000003Apr 17, 2008
Austria142636Sep 15, 1996
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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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