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Last Updated: December 9, 2024

IMATINIB MESYLATE Drug Patent 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, Chartwell Rx, Dr Reddys, Eugia Pharma, Hikma, Mylan, Natco Pharma Ltd, Qilu Pharm Hainan, Shilpa, Sun Pharm, Teva Pharms Usa, and Zydus Pharms. and is included in fourteen NDAs.

The generic ingredient in IMATINIB MESYLATE is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-three 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
Drug Prices for IMATINIB MESYLATE

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Recent Clinical Trials for IMATINIB MESYLATE

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

SponsorPhase
Inhibikase Therapeutics, Inc.Phase 1
Sarit AssoulinePhase 3
Ningbo No. 1 HospitalPhase 2

See all IMATINIB MESYLATE clinical trials

Medical Subject Heading (MeSH) Categories for IMATINIB MESYLATE
Paragraph IV (Patent) Challenges for IMATINIB MESYLATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GLEEVEC Tablets imatinib mesylate 100 mg and 400 mg 021588 1 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
Zydus Pharms IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 210658-002 Apr 8, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal Pharms IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 207495-001 Feb 8, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Natco Pharma Ltd IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 207818-002 Mar 1, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 078340-002 Dec 3, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 208429-001 Jan 17, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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