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Last Updated: November 13, 2019

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ICLUSIG Drug Profile

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When do Iclusig patents expire, and what generic alternatives are available?

Iclusig is a drug marketed by Ariad and is included in one NDA. There are three patents protecting this drug.

This drug has seventy-four patent family members in twenty countries.

The generic ingredient in ICLUSIG is ponatinib hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.

Drug patent expirations by year for ICLUSIG
Drug Prices for ICLUSIG

See drug prices for ICLUSIG

Generic Entry Opportunity Date for ICLUSIG
Generic Entry Date for ICLUSIG*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ICLUSIG

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

SponsorPhase
Antonio FojoPhase 2
Millennium Pharmaceuticals, Inc.Phase 2
Versailles HospitalPhase 2

See all ICLUSIG clinical trials

Recent Litigation for ICLUSIG

Identify potential future generic entrants

District Court Litigation
Case NameDate
Ariad Pharmaceuticals, Inc. v. Matal

See all ICLUSIG litigation

Pharmacology for ICLUSIG
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for ICLUSIG
0LI
1114544-31-8
3-(2-(Imidazo(1,2-b)pyridazin-3-yl)ethynyl)-4-methyl-N-(4-((4-methylpiperazin-1- yl)methyl)-3-(trifluoromethyl)phenyl)benzamide
3-(2-(Imidazo(1,2-b)pyridazin-3-yl)ethynyl)-4-methyl-N-(4-((4-methylpiperazin-1- yl)methyl)-3-(trifluoromethyl)phenyl)benzamide monohydrochloride
3-(2-(Imidazo[1,2-b]pyridazin-3-yl)ethynyl)-4-methyl-N-(4-((4-methylpiperazin-1-yl)methyl)-3-(trifluoromethyl)phenyl)benzamide
3-(2-{imidazo[1,2-b]pyridazin-3-yl}ethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide hydrochloride
3-(2-Imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl]-benzamide
3-(2-Imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl]benzamide
3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl]benzamide
3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-(4-((4-methylpiperazin-1-yl)methyl)-3-(trifluoromethyl)phenyl)benzamide
3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-(4-((4-methylpiperazin-1-yl)methyl)-3-(trifluoromethyl)phenyl)benzamide hydrochloride
3-(Imidazo[1,2-B]pyridazin-3-Ylethynyl)-4-Methyl-N-{4-[(4-Methylpiperazin-1-Yl)methyl]-3-(Trifluoromethyl)phenyl}benzamide
3-[2-(imidazo[1,2-b]pyridazin-3-yl)ethynyl]-4-methyl-n-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide
4340891KFS
943319-70-8
96R6PU3D8J
AB0008178
AB01565847_03
ABP000881
AC-26973
AKOS015995214
AKOS030621539
AM81261
AOB3899
AOB87302
AP 24534
AP 24534 hydrochloride
AP-24534
AP-24534 HCl
AP-24534, Ponatinib, AP24534
AP24534
AP24534 - Ponatinib
AP24534 HCL
AP24534 Hydrochloride
AP24534,Ponatinib
AP24534(Ponatinib)
AS-16772
AS-19133
BC659935
BCP02037
BCP10906
BCP9000307
BCPP000397
BDBM50322535
Benzamide, 3-(2-imidazo(1,2-b)pyridazin-3-ylethynyl)-4-methyl-N-(4-((4-methyl-1- piperazinyl)methyl)-3-(trifluoromethyl)phenyl)-
Benzamide, 3-(2-imidazo(1,2-b)pyridazin-3-ylethynyl)-4-methyl-N-(4-((4-methyl-1- piperazinyl)methyl)-3-(trifluoromethyl)phenyl)-, hydrochloride (1:1)
BENZAMIDE, 3-(2-IMIDAZO[1,2-B]PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-[4-[(4-METHYL-1-PIPERAZINYL)METHYL]-3-(TRIFLUOROMETHYL)PHENYL]-
BRD-K44227013-001-02-3
BWTNNZPNKQIADY-UHFFFAOYSA-N
C29H27F3N6O
C29H28ClF3N6O
CHEBI:78543
CHEMBL1171837
CHEMBL2105708
CS-0204
CTK5H6398
D09950
D09951
DB08901
DTXSID50149655
DTXSID50241426
EX-A067
FT-0660376
GTPL5890
HMS3654H16
HSDB 8184
HY-12047
Iclusig (TN)
KB-80068
KS-00000772
MLS006010166
MolPort-009-679-483
NCGC00263152-01
NCGC00263152-02
NCGC00263152-14
PB34916
PHXJVRSECIGDHY-UHFFFAOYSA-N
Ponatinb
PONATINIB
Ponatinib (AP24534)
Ponatinib (HCl salt)
Ponatinib (USAN/INN)
Ponatinib [USAN:INN]
Ponatinib HCl
Ponatinib hydrochloride
Ponatinib hydrochloride (JAN/USAN)
Ponatinib hydrochloride [USAN]
Ponatinib Mono-hydrochloride
ponatinibum
Q-4579
QCR-6
RL05926
RT-011294
S1490
SC-53014
SCHEMBL15798559
SCHEMBL589260
SMR004701274
SW218091-2
SYN1116
UNII-4340891KFS
UNII-96R6PU3D8J
X4747
Y1466
ZINC36701290

US Patents and Regulatory Information for ICLUSIG

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-001 Dec 14, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-003 Apr 23, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-001 Dec 14, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-002 Dec 14, 2012 RX Yes Yes   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

Supplementary Protection Certificates for ICLUSIG

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1973545 2013/059 Ireland   Start Trial PRODUCT NAME: PONATINIB IN ALL FORMS PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
1973545 PA2013027,C1973545 Lithuania   Start Trial PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: EU/1/13/839/001, 2013 07 03 EU/1/13/839/002, 2013 07 03 EU/1/13/839/003, 2013 07 03 EU/1/13/839/004 20130703
1973545 CR 2013 00066 Denmark   Start Trial PRODUCT NAME: PONATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF INCLUDING THE HYDROCHLORIDE SALT THEREOF; REG. NO/DATE: EU/1/13/839/001-004 20130701
1973545 C01973545/01 Switzerland   Start Trial PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: SWISSMEDIC 63097 12.02.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Johnson and Johnson
McKinsey
AstraZeneca
Medtronic

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