Arranon Patent Expiration

Arranon is a drug owned by Sandoz Inc. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 13, 2017. Details of Arranon's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5424295 9-β-D-arabinofuranasyl-2-amino-6-methaoxy-9H-purine
Jun, 2017

(7 years ago)

Expired
US5747472 Therapeutic methods for using ARA-G derivatives
Feb, 2013

(11 years ago)

Expired
US5492897 Method for treating T-cell lymphoblastic leukemia with ara-G nucleoside derivatives
Feb, 2013

(11 years ago)

Expired
US5821236 Tumor treatment with arabinofuranosyl purine derivatives
Feb, 2013

(11 years ago)

Expired


FDA has granted several exclusivities to Arranon. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Arranon, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Arranon.

Exclusivity Information

Arranon holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Arranon's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE) Oct 28, 2012

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US patents provide insights into the exclusivity only within the United States, but Arranon is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Arranon's family patents as well as insights into ongoing legal events on those patents.

Arranon's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Arranon's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 13, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Arranon Generics:

Nelarabine is the generic name for the brand Arranon. 9 different companies have already filed for the generic of Arranon, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Arranon's generic





About Arranon

Arranon is a drug owned by Sandoz Inc. It is used for treating T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma that have not responded to or relapsed after two chemotherapy regimens. Arranon uses Nelarabine as an active ingredient. Arranon was launched by Sandoz in 2005.

Approval Date:

Arranon was approved by FDA for market use on 28 October, 2005.

Active Ingredient:

Arranon uses Nelarabine as the active ingredient. Check out other Drugs and Companies using Nelarabine ingredient

Treatment:

Arranon is used for treating T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma that have not responded to or relapsed after two chemotherapy regimens.

Dosage:

Arranon is available in injectable form for intravenous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
250MG/50ML (5MG/ML) INJECTABLE Prescription INTRAVENOUS