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Last Updated: December 2, 2021

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IMATINIB MESYLATE - Generic Drug Details

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What are the generic drug sources for imatinib mesylate and what is the scope of freedom to operate?

Imatinib mesylate is the generic ingredient in two branded drugs marketed by Novartis, 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 fifteen 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-four suppliers are listed for this compound.

Drug Prices for IMATINIB MESYLATE

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Recent Clinical Trials for IMATINIB MESYLATE

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SponsorPhase
Zhejiang Cancer HospitalPhase 2
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 2
Taizhou Hospital of Zhejiang ProvincePhase 2

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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
Dr Reddys IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 206547-002 Aug 13, 2018 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hikma Pharms IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 207586-001 Jul 13, 2018 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Eugia Pharma IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 212773-002 Jul 23, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-002 Apr 18, 2003 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Sun Pharm IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 078340-001 Dec 3, 2015 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Breckenridge IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 205990-001 Feb 8, 2019 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

Expired US Patents for IMATINIB MESYLATE

Supplementary Protection Certificates for IMATINIB MESYLATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0564409 02C0012 France ⤷  Free Forever Trial PRODUCT NAME: IMATINIB MESILATE; NAT. REGISTRATION NO/DATE: EU/1/01/198/001 20011107; FIRST REGISTRATION: LI - IKS 55 807 20010621
0564409 C300086 Netherlands ⤷  Free Forever Trial PRODUCT NAME: IMATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET MESILAAT; NATL. REGISTRATION NO/DATE: EU/1/01/198/001 - 006 20011107; FIRST REGISTRATION: CH IKS 55807 20010621
0564409 SPC/GB02/016 United Kingdom ⤷  Free Forever Trial 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 2002/005 Ireland ⤷  Free Forever Trial PRODUCT NAME: IMATINIB OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; NAT REGISTRATION NO/DATE: EU/1/01/198/001-006 20011107; FIRST REGISTRATION NO/DATE: CH 55807 55807 01 55807 02 20010621; PAEDIATRIC INVESTIGATION PLAN: P/0028/2012
0564409 C00564409/01 Switzerland ⤷  Free Forever Trial PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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