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 US6958335

(Pediatric)

Treatment of gastrointestinal stromal tumors Jun 19, 2022

(Expired)

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

(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 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

(Pediatric)

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

(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 US7544799 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 Jan 16, 2019

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

(Expired)

Novartis
Gleevec US5521184

(Pediatric)

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

(Expired)

Novartis
Gleevec US5521184 Pyrimidine derivatives and processes for the preparation thereof Jan 04, 2015

(Expired)

Novartis



Imatinib Mesylate's Family Patents

Family Patents

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Imatinib Mesylate Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


1. 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





2. 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


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
North York Apotex Inc.
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
Brantford Apotex Pharmachem Inc.
Toronto Apotex Inc.
Richmond Hill Apotex Inc.
India
Bangalore Apotex Pharmachem India Pvt Ltd.
Bengaluru Apotex Research Private Limited
Bangalore Apotex Research Private Limited - Bioequivalence Centre





3. 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


Manufacturing Plant Locations
New

Breckenridge'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 Breckenridge as present at those locations.

Country City Firm Name
United States
Berlin Breckenridge Pharmaceutical, Inc
Boca Raton Breckenridge Pharmaceutical, Inc.





4. 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





5. 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





6. 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


Manufacturing Plant Locations
New

Eugia Pharma'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 Eugia Pharma as present at those locations.

Country City Firm Name
India
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited





7. 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


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Cherry Hill Hikma Pharmaceuticals USA Inc.
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





8. 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


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
Saint Albans Mylan Technologies, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
San Carlos Mylan Pharmaceuticals Inc.
Rockford Mylan Institutional, Inc.
Morgantown Mylan Specialty, L.P.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Greensboro Mylan Pharmaceuticals Inc
India
Sarigam Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Hosur Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





9. 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


Manufacturing Plant Locations
New

Natco Pharma Ltd'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 Natco Pharma Ltd as present at those locations.

Country City Firm Name
India
Hyderabad NATCO PHARMA LTD
Rangareddy District Natco Pharma Ltd. - Chemical Division





10. 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





11. 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


Manufacturing Plant Locations
New

Shilpa'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 Shilpa as present at those locations.

Country City Firm Name
United States
Minneapolis Shilpa Gupta
India
Bengaluru Shilpa Medicare Limited
Hyderbad Shilpa Medicare Limited
Chicksugur, Raichur Shilpa Pharma Lifesciences Limited
Polepally, Jadcherla Shilpa Medicare Limited
Hyderabad Shilpa Medicare Limited





12. 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


Manufacturing Plant Locations
New

Sun Pharm'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 Sun Pharm as present at those locations.

Country City Firm Name
United States
Billerica Sun Pharmaceutical Industries, Inc.
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
Lexington Sun Pharmaceutical Industries Inc
India
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Punjab Sun Pharmaceutical Industries, Inc.
Vadodara Sun Pharmaceutical Industries Ltd.
Halol Sun Pharmaceutical Industries Ltd.
Dadra Sun Pharmaceutical Industries Limited
Bharuch Sun Pharmaceutical Industries Ltd
Baruch Sun Pharmaceutical Industries Ltd.
Ahmednagar Sun Pharmaceutical Industries Limited
Mohali Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
New Delhi Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd





13. 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





14. 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