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Generated: November 18, 2018

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

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
Synonyms for GLEEVEC
111GE005
127I571
220127-57-1
4-?[(4-?METHYL-?1-?PIPERAZINYL)METHYL]-?N-?[4-?METHYL-?3-?[[4-?(3-?PYRIDINYL)-?2-?PYRIMIDINYL]AMINO]PHENYL]-?METHANESULFONATE-?BENZAMIDE
4-(4-Methyl-piperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin- 3-yl)-pyrimidin-2-ylamino)-phenyl]-benzamidemethanesulfonic acid salt
4-(4-Methyl-piperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-phenyl]-benzamide methanesulfonic acid salt
4-[(4-Methyl-1-piperazinyl)-methyl]-N-{4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]-amino]-phenyl}-benzamide monomethanesulphonate
4-[(4-methyl-1-piperazinyl)methyl]-n-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate
4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]-benzamide monomethanesulfonate
4-[(4-methyl-1-piperazinyl)methyl]-n-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide methanesulfonate
4-[(4-methylpiperazin-1-yl)methyl]-N-(4-methyl-3-{[4-(pyridin-3-yl)pyrimidin-2-yl]amino}phenyl)benzamide methanesulfonate
4-[(4-Methylpiperazin-1-yl)methyl]-N-[4-methyl-3-[(4-pyridin-3-ylpyrimidin-2-yl) amino]phenyl]benzamide methanesulfonate
4-[(4-methylpiperazin-1-yl)methyl]-N-{4-methyl-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]phenyl}benzamide methanesulfonate
45150-EP2270008A1
45150-EP2277867A2
45150-EP2280003A2
45150-EP2289893A1
45150-EP2292617A1
45150-EP2298768A1
45150-EP2305682A1
45150-EP2308861A1
45150-EP2308879A1
45150-EP2311821A1
8A1O1M485B
A-2359
A809313
A815828
AB0005762
AB1008575
ABP000865
AC-525
AC1L3WY1
ACT05102
AK-44930
AKOS015852497
AM20080900
AN-5298
AOB6752
BC215795
BCP9000776
BCPP000204
Benzamide, 4-((4-methyl-1-piperazinyl)methyl)-N-(4-methyl-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)phenyl)-, monomethanesulfonate
Benzamide, 4-((4-methyl-1-piperazinyl)methyl)-N-(4-methyl-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)phenyl)-monomethanesulfonate
Benzamide, 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]-, methanesulfonate (1:1)
Benzamide,monomethanesulfonate
Bio-0051
C29H31N7O.CH4SO3
C30H35N7O4S
CAS-220127-57-1
CCG-101175
CGP 53715
CGP 57148B
CGP-571
CGP-57148B
CHEBI:31690
CHEMBL1642
CI0026
CPD000469175
D01441
D0Z6KI
DSSTox_CID_20502
DSSTox_GSID_40502
DSSTox_RID_79501
DTXSID9040502
EBD22648
EX-A954
FC0015
FT-0080060
FT-0601612
GGP-57148B
Gleevac
Gleevec (Imatinib mesylate)
Gleevec (TN)
Glivec
Glivec (TN)
HE231008
HMS2052B09
HMS2233D16
HMS3265E01
HMS3265E02
HMS3265F01
HMS3265F02
HMS3372O12
HMS3394B09
HMS3654C07
HSDB 7142
HY-50946
I06-0363
I0936
Imatinib (mesylate)
Imatinib mesilate
Imatinib mesilate (JAN)
Imatinib mesylate
Imatinib Mesylate (STI571)
Imatinib mesylate (USAN)
Imatinib mesylate [USAN]
imatinib mesylate mesylate
Imatinib Mesylate,Gleevec,Glivec,CGP-57148B,STI-571
Imatinib mesylate;
Imatinib Mesylate/Gleevec, Glivec, CGP-57148B, STI-571
imatinib methanesulfonate
imatinib monomesylate
Imatinib monomethanesulfonate
Imatinib, methanesulfonate salt
Imatinib(free base)
ImatinibMesylate
J-523068
J10205
KB-52541
KS-000002AE
KS-1236
LS-27113
methanesulfonic acid; 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide
methanesulfonic acid; 4-[(4-methylpiperazin-1-yl)methyl]-N-[4-methyl-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]phenyl]benzamide
methanesulfonic acid; 4-[(4-methylpiperazin-1-yl)methyl]-N-[4-methyl-3-[[4-(3-pyridyl)pyrimidin-2-yl]amino]phenyl]benzamide
methanesulfonic acid;4-[(4-methylpiperazin-1-yl)methyl]-N-[4-methyl-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]phenyl]benzamide
MFCD04307699
MLS001401456
MolPort-003-986-615
N-(4-methyl-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamide methanesulfonate
N-(4-methyl-3-(4-(pyridin-3-yl)pyrimidin-2-ylamino)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamide methanesulfonate
N-(4-methyl-3(4-(pyridin-3-yl)pyridin-2-ylamino)phenyl-4-((4-methylpiperazin-1-yl)methyl)benzamide
NC00425
NCGC00159456-02
NCGC00159456-11
NSC-716051
NSC716051
PubChem18211
PubChem19416
Q-201232
QTI-571
RS0020
s1026
SAM001246622
SCHEMBL8217
Shantinib
SMR000469175
ST-1571 Mesylate
ST2413118
SYN1046
TL8001825
TL8006192
Tox21_111684
Tox21_111684_1
TRA0018756
UNII-8A1O1M485B
YLMAHDNUQAMNNX-UHFFFAOYSA-N

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-001 Apr 18, 2003 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-002 May 10, 2001 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-002 Apr 18, 2003 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-001 Apr 18, 2003 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-002 Apr 18, 2003 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 TABLET;ORAL 021588-001 Apr 18, 2003 ➤ Sign Up ➤ Sign Up
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-001 May 10, 2001 ➤ Sign Up ➤ Sign Up
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-002 May 10, 2001 ➤ Sign Up ➤ Sign Up
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-002 Apr 18, 2003 ➤ Sign Up ➤ Sign Up
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 Date
➤ Subscribe Tablets 100 mg and 400 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Capsules 400 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for GLEEVEC

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

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Mallinckrodt
Citi
Baxter
Johnson and Johnson
Merck
McKinsey
Federal Trade Commission
Healthtrust

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