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Last Updated: February 9, 2023

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, 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-five 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
Inhibikase Therapeutics, Inc.Phase 1
Sarit AssoulinePhase 3
Taizhou Hospital of Zhejiang ProvincePhase 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
Eugia Pharma IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 212773-002 Jul 23, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Breckenridge IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 205990-001 Feb 8, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms Usa IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 204285-002 Aug 4, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-002 Apr 18, 2003 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 207586-001 Jul 13, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Wockhardt Bio Ag IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 208429-001 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 021588-002 Apr 18, 2003 See Plans and Pricing See Plans and Pricing
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-001 May 10, 2001 See Plans and Pricing See Plans and Pricing
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-002 May 10, 2001 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
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-002 May 10, 2001 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for imatinib mesylate

Country Patent Number Title Estimated Expiration
Denmark 1332137 See Plans and Pricing
China 1622808 See Plans and Pricing
Norway 20031833 See Plans and Pricing
Brazil 0114870 See Plans and Pricing
World Intellectual Property Organization (WIPO) 0234727 See Plans and Pricing
European Patent Office 1332137 TRAITEMENT DE TUMEURS STROMALES GASTRO-INTESTINALES (TREATMENT OF GASTROINTESTINAL STROMAL TUMORS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for imatinib mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 C300086 Netherlands See Plans and Pricing 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 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 2002/005 Ireland See Plans and Pricing 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 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.