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Last Updated: August 7, 2020

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GLEEVEC Drug Profile

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When do Gleevec patents expire, and when can generic versions of Gleevec launch?

Gleevec is a drug marketed by Novartis and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has thirty-five patent family members in twenty-five countries.

The generic ingredient in GLEEVEC is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.

US ANDA Litigation and Generic Entry Outlook for Gleevec

A generic version of GLEEVEC was approved as imatinib mesylate by SUN PHARM on December 3rd, 2015.

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Drug patent expirations by year for GLEEVEC
Drug Prices for GLEEVEC

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Recent Clinical Trials for GLEEVEC

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

SponsorPhase
Cancer Institute and Hospital, Chinese Academy of Medical SciencesPhase 2
Xiangya Hospital of Central South UniversityEarly Phase 1
ECOG-ACRIN Cancer Research GroupPhase 2

See all GLEEVEC clinical trials

Pharmacology for GLEEVEC
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for GLEEVEC
Tradename Dosage Ingredient NDA Submissiondate
GLEEVEC TABLET;ORAL imatinib mesylate 021588

US Patents and Regulatory Information for GLEEVEC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-001 May 10, 2001 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-001 Apr 18, 2003 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-002 May 10, 2001 DISCN Yes No   Start Trial   Start Trial Y   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 GLEEVEC

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 GLEEVEC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0564409 SPC005/2002 Ireland   Start Trial SPC005/2002: 20051123, EXPIRES: 20160620
0564409 2002/005 Ireland   Start 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
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AstraZeneca
Dow
Johnson and Johnson

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