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Generated: November 19, 2018

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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.

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
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.

Pharmacology for ICLUSIG
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for ICLUSIG
0LI
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
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
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
AB0008178
AB01565847_03
ABP000881
AC-26973
AK172051
AKOS015995214
AM81261
AOB87302
AP 24534
AP-24534
AP-24534, Ponatinib, AP24534
AP24534
AP24534 - Ponatinib
AP24534,Ponatinib
AP24534(Ponatinib)
AS-19133
BC659935
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]-
BRD-K44227013-001-02-3
C29H27F3N6O
CHEBI:78543
CHEMBL1171837
CS-0204
CTK5H6398
D09950
D0H0EQ
DB08901
DTXSID50241426
EX-A067
FT-0660376
GTPL5890
HE071231
HE418486
HMS3654H16
HY-12047
Iclusig (TN)
KB-80068
KS-00000772
MFCD17215203
MLS006010166
MolPort-009-679-483
NCGC00263152-01
NCGC00263152-02
PB34916
PHXJVRSECIGDHY-UHFFFAOYSA-N
Ponatinb
PONATINIB
Ponatinib (AP24534)
Ponatinib (USAN/INN)
Ponatinib [USAN:INN]
ponatinibum
Q-4579
QCR-6
RL05926
RT-011294
S1490
SC-53014
SCHEMBL589260
SMR004701274
SYN1116
UNII-4340891KFS
X4747
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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-003 Apr 23, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-002 Dec 14, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-001 Dec 14, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-002 Dec 14, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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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Supplementary Protection Certificates for ICLUSIG

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013027,C1973545 Lithuania ➤ Try a Free 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
327 Luxembourg ➤ Try a Free Trial PRODUCT NAME: PONATINIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE
2013 00066 Denmark ➤ Try a Free Trial PRODUCT NAME: POATINIB, HERUNDER PONATINIB HYDROCHLORID; REG. NO/DATE: EU/1/13/839/001-004 20130701
0130033 00093 Estonia ➤ Try a Free Trial PRODUCT NAME: PONATINIIB;REG NO/DATE: K(2013)4238 (LOPLIK) 01.07.2013
2013 00066 Denmark ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Deloitte
Boehringer Ingelheim
US Army
Julphar
Daiichi Sankyo
Merck
Colorcon
Covington

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