.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

GLEEVEC Drug Profile

« Back to Dashboard
Gleevec is a drug marketed by Novartis and is included in two NDAs. It is available from three suppliers. There are five patents protecting this drug and two Paragraph IV challenges.

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

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

Summary for Tradename: GLEEVEC

Patents:5
Applicants:1
NDAs:2
Suppliers / Packagers: see list3

Pharmacology for Tradename: GLEEVEC

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

Clinical Trials for: GLEEVEC

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
GLEEVEC
imatinib mesylate
CAPSULE;ORAL021335-001May 10, 2001DISCNNoRE43932*PED<disabled> <disabled>
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-002Apr 18, 2003RXYes7,544,799*PED<disabled>Y<disabled>
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-002Apr 18, 2003RXYes<disabled><disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for Tradename: GLEEVEC

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-001Apr 18, 20035,521,184*PED<disabled>
Novartis
GLEEVEC
imatinib mesylate
CAPSULE;ORAL021335-001May 10, 20015,521,184*PED<disabled>
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-002Apr 18, 20035,521,184*PED<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV activity for: GLEEVEC

Drugname Dosage Strength RLD Submissiondate
imatinib mesylateTablets100 mg and 400 mgGleevec3/12/2007
imatinib mesylateCapsules400 mgGleevec1/24/2014

Non-Orange Book Patents for Tradename: 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
5,543,520 Pyrimidine derivatives<disabled in preview>
7,151,106Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: GLEEVEC

Country Document Number Estimated Expiration
Norway302473<disabled in preview>
Norway331016<disabled in preview>
Turkey200000060<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: GLEEVEC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0564409/01Switzerland<disabled>PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
02/005Ireland<disabled>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
C/GB02/016United Kingdom<disabled>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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

`abc