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Last Updated: August 10, 2020

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IMATINIB MESYLATE Drug Profile

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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, Hikma, Mylan, Natco Pharma Ltd, Shilpa Medicare Ltd, Sun Pharm, Teva Pharms Usa, Wockhardt Bio Ag, and Zydus Pharms. and is included in twelve NDAs.

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

US ANDA 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
Drug Prices for IMATINIB MESYLATE

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Recent Clinical Trials for IMATINIB MESYLATE

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

SponsorPhase
Imperial College LondonPhase 2
University of CambridgePhase 2
University of SheffieldPhase 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

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   Start Trial   Start Trial   Start Trial
Sun Pharm IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 078340-002 Dec 3, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 210658-002 Apr 8, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 206547-001 Aug 13, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 079179-002 Aug 5, 2016 AB RX No No   Start Trial   Start Trial   Start 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
McKesson
McKinsey
AstraZeneca
Colorcon
Merck

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