GLEEVEC Drug Patent Profile

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.

The generic ingredient in GLEEVEC is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-three 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 3^rd, 2015.

Summary for GLEEVEC

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	235
Patent Applications:	3,903
Drug Prices:	Drug price information for GLEEVEC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLEEVEC
What excipients (inactive ingredients) are in GLEEVEC?	GLEEVEC excipients list
DailyMed Link:	GLEEVEC at DailyMed

See drug prices for GLEEVEC

Recent Clinical Trials for GLEEVEC

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

Sponsor	Phase
Reema A. Patel	Phase 2
H. Jean Khoury Cure CML Consortium	Phase 2
Research Institute for Gastroenterology and Liver Diseases (RIGLD)	Phase 1/Phase 2

See all GLEEVEC clinical trials

Pharmacology for GLEEVEC

Drug Class	Kinase Inhibitor
Mechanism of Action	Bcr-Abl Tyrosine Kinase Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors

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
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-002	Apr 18, 2003	AB	RX	Yes	Yes
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-002	May 10, 2001		DISCN	Yes	No
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-001	Apr 18, 2003	AB	RX	Yes	No

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
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-001	Apr 18, 2003
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-001	Apr 18, 2003
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-001	May 10, 2001

International Patents for GLEEVEC

See the table below for patents covering GLEEVEC around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	0301512
China	1043531
Japan	2004512328
Hong Kong	1058193

Supplementary Protection Certificates for GLEEVEC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0564409	C300086	Netherlands		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	2002/005	Ireland		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	C00564409/01	Switzerland		PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
0564409	90908	Luxembourg