Nelarabine Patent Expiration

Nelarabine 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. It was first introduced by Sandoz Inc in its drug Arranon on Oct 28, 2005. 11 different companies have introduced drugs containing Nelarabine.


Nelarabine Patents

Given below is the list of patents protecting Nelarabine, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Arranon US5424295 9-β-D-arabinofuranasyl-2-amino-6-methaoxy-9H-purine Jun 13, 2017

(Expired)

Sandoz
Arranon US5492897 Method for treating T-cell lymphoblastic leukemia with ara-G nucleoside derivatives Feb 20, 2013

(Expired)

Sandoz
Arranon US5747472 Therapeutic methods for using ARA-G derivatives Feb 20, 2013

(Expired)

Sandoz
Arranon US5821236 Tumor treatment with arabinofuranosyl purine derivatives Feb 20, 2013

(Expired)

Sandoz



Nelarabine's Family Patents

Family Patents

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Nelarabine Generic API Manufacturers

Several generic applications have been filed for Nelarabine. The first generic version for Nelarabine was by Zydus Pharmaceuticals Usa Inc and was approved on Nov 17, 2021. And the latest generic version is by Msn Laboratories Private Ltd and was approved on Sep 13, 2024.

Given below is the list of companies who have filed for Nelarabine generic, along with the locations of their manufacturing plants worldwide.


1. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 1 generic for Nelarabine. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG/50ML (5MG/ML)

injectable Prescription INTRAVENOUS AP Aug 1, 2024


Manufacturing Plant Locations
New

Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.

Country City Firm Name
India
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Vadodara Alembic Pharmaceuticals, Ltd
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)





2. AMNEAL

Amneal Eu Ltd has filed for 1 generic for Nelarabine. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG/50ML (5MG/ML)

injectable Prescription INTRAVENOUS AP Apr 4, 2023


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Piscataway Amneal Pharmaceuticals, LLC
Branchburg Amneal Pharmaceuticals, LLC
Paterson Amneal Pharmaceuticals, Llc
East Hanover Amneal Pharmaceuticals LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Glasgow Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad Amneal Oncology Private Limited





3. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 1 generic for Nelarabine. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG/50ML (5MG/ML)

injectable Prescription INTRAVENOUS AP Dec 23, 2022





4. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 1 generic for Nelarabine. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG/50ML (5MG/ML)

injectable Prescription INTRAVENOUS AP Jan 3, 2024





5. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 1 generic for Nelarabine. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG/50ML (5MG/ML)

injectable Prescription INTRAVENOUS AP Jan 10, 2023





6. MSN

Msn Laboratories Private Ltd has filed for 1 generic for Nelarabine. Given below are the details of the strengths of this generic introduced by Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG/50ML (5MG/ML)

injectable Prescription INTRAVENOUS AP Sep 13, 2024


Manufacturing Plant Locations
New

Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.

Country City Firm Name
India
Yadadri Bhuvanagiri District MSN Organics Private Limited
Medak MSN LIFE SCIENCES PRIVATE LIMITED
Sangareddy MSN Laboratories Private Ltd.
Rangareddy District MSN Laboratories Private Limited
Isnapur MSN Laboratories Private Limited, Unit-II
Jinnaram, Sangareddy MSN Laboratories Private Limited - Formulations Division
Rangareddy District MSN Laboratories Private Limited (Formulations Division, Unit-II)
Sangareddy MSN Laboratories Private Limited, R&D Center
Sangareddy MSN Pharmachem Private Limited
Kamareddy MSN Life Sciences Private Limited
United States
Piscataway MSN PHARMACEUTICALS INC





7. NEXUS

Nexus Pharmaceuticals Llc has filed for 1 generic for Nelarabine. Given below are the details of the strengths of this generic introduced by Nexus.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG/50ML (5MG/ML)

injectable Prescription INTRAVENOUS AP Jun 2, 2023


Manufacturing Plant Locations
New

Nexus's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Nexus as present at those locations.

Country City Firm Name
United States
Adams Nexus Cooperative
San Diego Nexus Dx, Inc
Brownsdale Nexus Cooperative
Cottonwood Heights Nexus CMF, LLC
Salt Lake City Nexus Spine, LLC
Bedford Park Nexus Distribution Corporation
Le Roy Nexus Cooperative
Lansing Nexus Cooperative
Alden Nexus Cooperative
Lenexa Nexus Medical LLC
Rose Creek Nexus Cooperative
Emmons Nexus Cooperative
Conger Nexus Cooperative
Cerritos Nexus Foods Inc
Pleasant Prairie Nexus Pharmaceuticals Inc
Lincolnshire Nexus Pharmaceuticals, LLC
Bedford Park Nexus Distribution Corp.
Santa Fe Springs Nexus Foods, Inc.





8. SHORLA

Shorla Pharma Ltd has filed for 1 generic for Nelarabine. Given below are the details of the strengths of this generic introduced by Shorla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG/50ML (5MG/ML)

injectable Prescription INTRAVENOUS AP Mar 3, 2023





9. XGEN PHARMS

Xgen Pharmaceuticals Djb Inc has filed for 1 generic for Nelarabine. Given below are the details of the strengths of this generic introduced by Xgen Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG/50ML (5MG/ML)

injectable Prescription INTRAVENOUS AP Sep 5, 2024





10. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Nelarabine. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG/50ML (5MG/ML)

injectable Prescription INTRAVENOUS AP Nov 17, 2021