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Last Updated: November 21, 2019

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Imatinib mesylate - Generic Drug Details

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What are the generic drug sources for imatinib mesylate and what is the scope of freedom to operate?

Imatinib mesylate is the generic ingredient in two branded drugs marketed by Novartis, Amneal Pharms, Apotex Inc, Breckenridge, Dr Reddys, Mylan, Natco Pharma Ltd, Shilpa Medicare Ltd, Sun Pharm, Teva Pharms Usa, West-ward Pharms Int, and Wockhardt Bio Ag, and is included in thirteen NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Imatinib mesylate has eighty-two patent family members in thirty-two countries.

There are thirty-four drug master file entries for imatinib mesylate. Twenty-one suppliers are listed for this compound.

Drug Prices for imatinib mesylate

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Recent Clinical Trials for imatinib mesylate

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

SponsorPhase
Indiana UniversityEarly Phase 1
Children's Hospital Medical Center, CincinnatiEarly Phase 1
Purdue UniversityEarly Phase 1

See all imatinib mesylate clinical trials

Recent Litigation for imatinib mesylate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Novartis Pharmaceuticals Corporation v. Wockhardt Bio AG2016-01-26
Novartis Pharmaceuticals Corporation v. Shilpa Medicare Limited2015-11-30
Novartis Pharmaceuticals Corporation v. Natco Pharma Ltd.2015-10-28

See all imatinib mesylate litigation

Pharmacology for imatinib mesylate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for imatinib mesylate
Synonyms for imatinib mesylate
111GE005
127I571
220127-57-1
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
BCP01255
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
C29H31N7O.CH4SO3
C30H35N7O4S
CAS-220127-57-1
CCG-101175
CGP 53715
CGP 57148B
CGP-571
CGP-57148
CGP-57148B
CHEBI:31690
CHEMBL1642
CI0026
CPD000469175
D01441
DSSTox_CID_20502
DSSTox_GSID_40502
DSSTox_RID_79501
DTXSID9040502
EBD22648
EX-A954
FC0015
FT-0080060
FT-0601612
GGP-57148B
Gleevac
Gleevec
Gleevec (Imatinib mesylate)
Gleevec (TN)
Glivec
Glivec (TN)
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 (STI571)
Imatinib mesylate (USAN)
Imatinib mesylate [USAN]
imatinib mesylate mesylate
Imatinib mesylate, 98%
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 (95%)
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
sti-571
SW197805-4
SY013513
SYN1046
TL8001825
TL8006192
Tox21_111684
Tox21_111684_1
TRA0018756
UNII-8A1O1M485B
YLMAHDNUQAMNNX-UHFFFAOYSA-N
Paragraph IV (Patent) Challenges for IMATINIB MESYLATE
Tradename Dosage Ingredient NDA Submissiondate
GLEEVEC TABLET;ORAL imatinib mesylate 021588

US Patents and Regulatory Information for imatinib mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Breckenridge IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 205990-002 Feb 8, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 078340-002 Dec 3, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 207586-001 Jul 13, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
>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 imatinib mesylate

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

Supplementary Protection Certificates for imatinib mesylate

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

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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 verifification 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.