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Last Updated: March 18, 2024

ARRANON Drug Patent Profile


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When do Arranon patents expire, and when can generic versions of Arranon launch?

Arranon is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in ARRANON 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 Arranon

A generic version of ARRANON was approved as nelarabine by ZYDUS PHARMS on November 17th, 2021.

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Summary for ARRANON
Drug patent expirations by year for ARRANON
Drug Prices for ARRANON

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Recent Clinical Trials for ARRANON

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
M.D. Anderson Cancer CenterPhase 1/Phase 2
National Cancer Institute (NCI)Phase 1/Phase 2
The Leukemia and Lymphoma SocietyPhase 2

See all ARRANON clinical trials

Pharmacology for ARRANON

US Patents and Regulatory Information for ARRANON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz ARRANON nelarabine INJECTABLE;INTRAVENOUS 021877-001 Oct 28, 2005 AP RX Yes Yes ⤷  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

Expired US Patents for ARRANON

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sandoz ARRANON nelarabine INJECTABLE;INTRAVENOUS 021877-001 Oct 28, 2005 ⤷  Try a Trial ⤷  Try a Trial
Sandoz ARRANON nelarabine INJECTABLE;INTRAVENOUS 021877-001 Oct 28, 2005 ⤷  Try a Trial ⤷  Try a Trial
Sandoz ARRANON nelarabine INJECTABLE;INTRAVENOUS 021877-001 Oct 28, 2005 ⤷  Try a Trial ⤷  Try a Trial
Sandoz ARRANON nelarabine INJECTABLE;INTRAVENOUS 021877-001 Oct 28, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ARRANON

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

International Patents for ARRANON

See the table below for patents covering ARRANON around the world.

Country Patent Number Title Estimated Expiration
Austria 151637 ⤷  Try a Trial
Denmark 289788 ⤷  Try a Trial
South Africa 8803829 ⤷  Try a Trial
Spain 2091750 ⤷  Try a Trial
German Democratic Republic 293962 VERFAHREN ZUR HERSTELLUNG EINER PHARMAZEUTISCHEN FORMULIERUNG ⤷  Try a Trial
Israel 86531 ANTIVIRAL 9-ARABINOSYL- 6-SUBSTITUTED PURINE DERIVATIVES, THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ARRANON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0294114 300302 Netherlands ⤷  Try a Trial 300302, 20080527, EXPIRES: 20130526
0294114 55/2007 Austria ⤷  Try a Trial PRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 20070822
0294114 07C0058 France ⤷  Try a Trial PRODUCT NAME: NELARABINE, OU L?UN DE SES DERIVES PHYSIOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/403/001 DU 20070822; REGISTRATION NO/DATE AT EEC: EU/1/07/403/001 DU 20070822
0294114 SPC/GB08/006 United Kingdom ⤷  Try a Trial PRODUCT NAME: NELARABINE, OR ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ETHERS, ESTERS, OR SALTS OF SUCH ESTERS THEREOF.; REGISTERED: UK EU/1/07/403/001 20070822
0294114 91370 Luxembourg ⤷  Try a Trial 91370, EXPIRES: 20130527
0294114 C300302 Netherlands ⤷  Try a Trial PRODUCT NAME: NELARABINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR BAAR ZOUT, ETHER OF ESTER; REGISTRATION NO/DATE: EU/1/07/403/001 20070822
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.