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Last Updated: August 8, 2020

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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 patent protection?

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

Drug Prices for imatinib mesylate

See drug prices for imatinib mesylate

Recent Clinical Trials for imatinib mesylate

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

SponsorPhase
University of SheffieldPhase 2
National Institute for Health Research, United KingdomPhase 2
Imperial College LondonPhase 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
Breckenridge IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 205990-002 Feb 8, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 207586-001 Jul 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

Expired US Patents for imatinib mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-002 May 10, 2001   Start Trial   Start Trial
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-001 May 10, 2001   Start Trial   Start Trial
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-002 Apr 18, 2003   Start Trial   Start Trial
>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 C00564409/01 Switzerland   Start Trial PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
0564409 02C0012 France   Start 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   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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