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Serving leading biopharmaceutical companies globally:

Novartis
Citi
Federal Trade Commission
Healthtrust
Chinese Patent Office
Colorcon
UBS
QuintilesIMS
Queensland Health
Chubb

Generated: January 21, 2018

DrugPatentWatch Database Preview

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 are four patents protecting this drug and two Paragraph IV challenges.

This drug has forty-eight patent family members in thirty-one countries.

The generic ingredient in GLEEVEC is imatinib mesylate. There are thirty-three drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
Drug patent expirations by year for GLEEVEC
Pharmacology for GLEEVEC
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for GLEEVEC

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

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Expired US Patents for GLEEVEC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-001 May 10, 2001 ➤ Subscribe ➤ Subscribe
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-002 Apr 18, 2003 ➤ Subscribe ➤ Subscribe
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-002 May 10, 2001 ➤ Subscribe ➤ Subscribe
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-001 Apr 18, 2003 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for GLEEVEC
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 100 mg and 400 mg ➤ Subscribe 3/12/2007
➤ Subscribe Capsules 400 mg ➤ Subscribe 1/24/2014

Non-Orange Book US Patents for GLEEVEC

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,151,106 Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for GLEEVEC

Supplementary Protection Certificates for GLEEVEC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0564409/01 Switzerland ➤ Subscribe PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
C0012 France ➤ Subscribe PRODUCT NAME: IMATINIB MESILATE; NAT. REGISTRATION NO/DATE: EU/1/01/198/001 20011107; FIRST REGISTRATION: LI - IKS 55 807 20010621
C/GB02/016 United Kingdom ➤ Subscribe 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
00086 Netherlands ➤ Subscribe 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
02/005 Ireland ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Queensland Health
Medtronic
Moodys
Covington
Fish and Richardson
Federal Trade Commission
US Department of Justice
Julphar
QuintilesIMS

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