Imatinib Mesylate Patent Expiration

Imatinib Mesylate is Used for treating tumors and gastrointestinal stromal tumors (GIST) in patients with CD117 positive unresectable or metastatic disease. It was first introduced by Novartis Pharmaceuticals Corp in its drug Gleevec on May 10, 2001. 15 different companies have introduced drugs containing Imatinib Mesylate.


Imatinib Mesylate Patents

Given below is the list of patents protecting Imatinib Mesylate, 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
Gleevec US5521184 Pyrimidine derivatives and processes for the preparation thereof Jan 04, 2015

(Expired)

Novartis
Gleevec US5521184

(Pediatric)

Pyrimidine derivatives and processes for the preparation thereof Jul 04, 2015

(Expired)

Novartis
Gleevec US6894051 Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use May 23, 2019

(Expired)

Novartis
Gleevec US6894051

(Pediatric)

Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use Nov 23, 2019

(Expired)

Novartis
Gleevec US6958335 Treatment of gastrointestinal stromal tumors Dec 19, 2021

(Expired)

Novartis
Gleevec US6958335

(Pediatric)

Treatment of gastrointestinal stromal tumors Jun 19, 2022

(Expired)

Novartis
Gleevec US7544799 Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use Jan 16, 2019

(Expired)

Novartis
Gleevec US7544799

(Pediatric)

Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use Jul 16, 2019

(Expired)

Novartis
Gleevec USRE43932 Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use Jan 16, 2019

(Expired)

Novartis
Gleevec USRE43932 Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use Jul 16, 2018

(Expired)

Novartis
Gleevec USRE43932

(Pediatric)

Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use Jan 16, 2019

(Expired)

Novartis
Gleevec USRE43932

(Pediatric)

Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use Jul 16, 2019

(Expired)

Novartis


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Imatinib Mesylate Generics

Several generic applications have been filed for Imatinib Mesylate. The first generic version for Imatinib Mesylate was by Sun Pharmaceutical Industries Ltd and was approved on Dec 3, 2015. And the latest generic version is by Qilu Pharmaceutical Hainan Co Ltd and was approved on Jun 21, 2022.

Given below is the list of companies who have filed for Imatinib Mesylate generic.


1. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Imatinib Mesylate. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 100MG BASE tablet Prescription ORAL AB Jun 21, 2017
EQ 400MG BASE tablet Prescription ORAL AB Jun 21, 2017


2. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Imatinib Mesylate. 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
EQ 100MG BASE tablet Prescription ORAL AB Aug 13, 2018
EQ 400MG BASE tablet Prescription ORAL AB Aug 13, 2018


3. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Imatinib Mesylate. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 100MG BASE tablet Prescription ORAL AB Aug 4, 2016
EQ 400MG BASE tablet Prescription ORAL AB Aug 4, 2016


4. QILU PHARM HAINAN

Qilu Pharmaceutical Hainan Co Ltd has filed for 2 different strengths of generic version for Imatinib Mesylate. Given below are the details of the strengths of this generic introduced by Qilu Pharm Hainan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 100MG BASE tablet Prescription ORAL AB Jun 21, 2022
EQ 400MG BASE tablet Prescription ORAL AB Jun 21, 2022


5. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Imatinib Mesylate. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 400MG BASE tablet Discontinued ORAL N/A Jul 13, 2018
EQ 100MG BASE tablet Discontinued ORAL N/A Jul 13, 2018


6. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 2 different strengths of generic version for Imatinib Mesylate. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 100MG BASE tablet Prescription ORAL AB Jan 17, 2019
EQ 400MG BASE tablet Prescription ORAL AB Jan 17, 2019


7. SHILPA

Shilpa Medicare Ltd has filed for 2 different strengths of generic version for Imatinib Mesylate. Given below are the details of the strengths of this generic introduced by Shilpa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 100MG BASE tablet Prescription ORAL AB Jan 17, 2019
EQ 400MG BASE tablet Prescription ORAL AB Jan 17, 2019


8. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Imatinib Mesylate. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 100MG BASE tablet Prescription ORAL AB Dec 3, 2015
EQ 400MG BASE tablet Prescription ORAL AB Dec 3, 2015


9. AMNEAL PHARMS

Amneal Pharmaceuticals Of New York Llc has filed for 2 different strengths of generic version for Imatinib Mesylate. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 100MG BASE tablet Discontinued ORAL N/A Feb 8, 2019
EQ 400MG BASE tablet Discontinued ORAL N/A Feb 8, 2019


10. BRECKENRIDGE

Breckenridge Pharmaceutical Inc has filed for 2 different strengths of generic version for Imatinib Mesylate. Given below are the details of the strengths of this generic introduced by Breckenridge.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 100MG BASE tablet Discontinued ORAL N/A Feb 8, 2019
EQ 400MG BASE tablet Discontinued ORAL N/A Feb 8, 2019


11. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Imatinib Mesylate. 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
EQ 100MG BASE tablet Prescription ORAL AB Apr 8, 2020
EQ 400MG BASE tablet Prescription ORAL AB Apr 8, 2020


12. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 2 different strengths of generic version for Imatinib Mesylate. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 400MG BASE tablet Prescription ORAL AB Jul 23, 2020
EQ 100MG BASE tablet Prescription ORAL AB Jul 23, 2020


13. APOTEX

Apotex Inc has filed for 2 different strengths of generic version for Imatinib Mesylate. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 100MG BASE tablet Prescription ORAL AB Aug 5, 2016
EQ 400MG BASE tablet Prescription ORAL AB Aug 5, 2016


14. NATCO PHARMA LTD

Natco Pharma Ltd has filed for 2 different strengths of generic version for Imatinib Mesylate. Given below are the details of the strengths of this generic introduced by Natco Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 400MG BASE tablet Prescription ORAL AB Mar 1, 2019
EQ 100MG BASE tablet Prescription ORAL AB Mar 1, 2019