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Last Updated: June 13, 2021

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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 one Paragraph IV challenge.

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-five suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.

DrugPatentWatch® 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
H. Jean Khoury Cure CML ConsortiumPhase 2
Medical College of WisconsinPhase 2
Baylor College of MedicinePhase 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 2007-03-12

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   Get Started Free   Get Started Free Y   Get Started Free
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-002 Apr 18, 2003 AB RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-002 May 10, 2001 DISCN Yes No   Get Started Free   Get Started Free Y   Get Started Free
>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 TABLET;ORAL 021588-001 Apr 18, 2003   Get Started Free   Get Started Free
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-001 Apr 18, 2003   Get Started Free   Get Started Free
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-001 May 10, 2001   Get Started Free   Get Started Free
>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 C300086 Netherlands   Get Started Free 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 C00564409/01 Switzerland   Get Started Free PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
0564409 02C0012 France   Get Started Free 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
Baxter
AstraZeneca
Dow
Johnson and Johnson

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