Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

McKesson
Baxter
Merck
McKinsey
AstraZeneca
Medtronic

Last Updated: August 11, 2022

GLEEVEC Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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-four 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.

  Try it Free

Drug patent expirations by year for GLEEVEC
Drug Prices for GLEEVEC

See drug prices for GLEEVEC

Recent Clinical Trials for GLEEVEC

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

SponsorPhase
Medical College of WisconsinPhase 2
H. Jean Khoury Cure CML ConsortiumPhase 2
Research Institute for Gastroenterology and Liver Diseases (RIGLD)Phase 1/Phase 2

See all GLEEVEC clinical trials

Paragraph IV (Patent) Challenges for GLEEVEC
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 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 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
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-002 May 10, 2001 DISCN Yes 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 GLEEVEC

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 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

Supplementary Protection Certificates for GLEEVEC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0564409 SPC005/2002 Ireland See Plans and Pricing SPC005/2002: 20051123, EXPIRES: 20160620
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 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Baxter
AstraZeneca
Dow
Johnson and Johnson

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.