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Last Updated: January 27, 2023

Imatinib mesylate - Generic Drug Details


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What are the generic sources for imatinib mesylate and what is the scope of patent protection?

Imatinib mesylate is the generic ingredient in two branded drugs marketed by Novartis, Amneal Pharms, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Hikma, Mylan, Natco Pharma Ltd, Qilu Pharm Hainan, Shilpa, Sun Pharm, Teva Pharms Usa, Wockhardt Bio Ag, and Zydus Pharms, and is included in sixteen NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Imatinib mesylate has thirty-five patent family members in twenty-five countries.

There are thirty-four drug master file entries for imatinib mesylate. Twenty-six suppliers are listed for this compound.

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
First Affiliated Hospital of Zhejiang UniversityPhase 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
Teva Pharms Usa IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 204285-001 Aug 4, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 206547-002 Aug 13, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Shilpa IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 208302-002 Jan 17, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for imatinib mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-001 Apr 18, 2003 See Plans and Pricing See Plans and Pricing
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-002 Apr 18, 2003 See Plans and Pricing See Plans and Pricing
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-001 Apr 18, 2003 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for imatinib mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0564409 SPC/GB02/016 United Kingdom See Plans and Pricing PRODUCT NAME: IMATINIB (INN I.E. NON INTELLECTUAL PROPRIETARY NAME) OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; REGISTERED: CH IKS-NR: 55807 20010621; UK SG(2001) D/292083 20011108
0564409 02C0012 France See Plans and Pricing PRODUCT NAME: IMATINIB MESILATE; NAT. REGISTRATION NO/DATE: EU/1/01/198/001 20011107; FIRST REGISTRATION: LI - IKS 55 807 20010621
0564409 C00564409/01 Switzerland See Plans and Pricing PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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