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Last Updated: November 30, 2021

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Which patents cover Imatinib Mesylate, and what generic alternatives are available?

Imatinib Mesylate is a drug marketed by Amneal Pharms, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Hikma Pharms, Mylan, Natco Pharma Ltd, Shilpa, Sun Pharm, Teva Pharms Usa, Wockhardt Bio Ag, and Zydus Pharms. and is included in thirteen NDAs.

The generic ingredient in IMATINIB MESYLATE is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Imatinib Mesylate

A generic version of IMATINIB MESYLATE was approved as imatinib mesylate by SUN PHARM on December 3rd, 2015.

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Drug patent expirations by year for IMATINIB MESYLATE

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Recent Clinical Trials for IMATINIB MESYLATE

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

First Affiliated Hospital of Wenzhou Medical UniversityPhase 2
Zhejiang Cancer HospitalPhase 2
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 2

See all IMATINIB MESYLATE clinical trials

Pharmacology for IMATINIB MESYLATE
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for IMATINIB MESYLATE
Paragraph IV (Patent) Challenges for IMATINIB MESYLATE
Tradename Dosage Ingredient NDA Submissiondate
GLEEVEC TABLET;ORAL imatinib mesylate 021588 2007-03-12

US Patents and Regulatory Information for IMATINIB MESYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 207495-001 Feb 8, 2019 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Shilpa IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 208302-002 Jan 17, 2019 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Wockhardt Bio Ag IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 208429-002 Jan 17, 2019 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Dr Reddys IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 206547-001 Aug 13, 2018 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts

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.