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Last Updated: February 17, 2020

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PONATINIB HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for ponatinib hydrochloride and what is the scope of patent protection?

Ponatinib hydrochloride is the generic ingredient in one branded drug marketed by Ariad and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ponatinib hydrochloride has seventy-eight patent family members in twenty-one countries.

There is one drug master file entry for ponatinib hydrochloride. Two suppliers are listed for this compound.

Recent Clinical Trials for PONATINIB HYDROCHLORIDE

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SponsorPhase
Otsuka Beijing Research InstitutePhase 2
Apices Soluciones S.L.Phase 2
Incyte Biosciences UKPhase 2

See all PONATINIB HYDROCHLORIDE clinical trials

Recent Litigation for PONATINIB HYDROCHLORIDE

Identify potential future generic entrants

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

See all PONATINIB HYDROCHLORIDE litigation

Pharmacology for PONATINIB HYDROCHLORIDE
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for PONATINIB HYDROCHLORIDE
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 monohydrochloride
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-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-(4-((4-methylpiperazin-1-yl)methyl)-3-(trifluoromethyl)phenyl)benzamide hydrochloride
96R6PU3D8J
AKOS030621539
AOB3899
AP 24534 hydrochloride
AP-24534 HCl
AP24534 HCL
AP24534 Hydrochloride
AS-16772
BCP10906
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)
BWTNNZPNKQIADY-UHFFFAOYSA-N
C29H28ClF3N6O
CHEMBL2105708
D09951
DTXSID50149655
Iclusig
Iclusig (TN)
Ponatinib (HCl salt)
Ponatinib HCl
Ponatinib hydrochloride (JAN/USAN)
Ponatinib hydrochloride [USAN]
Ponatinib Mono-hydrochloride
SCHEMBL15798559
UNII-96R6PU3D8J
Y1466

US Patents and Regulatory Information for PONATINIB HYDROCHLORIDE

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 203469-003 Apr 23, 2015 RX Yes No   Start Trial   Start Trial Y Y   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 203469-002 Dec 14, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   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
>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 PONATINIB HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1973545 151 5025-2013 Slovakia   Start Trial (93) EU/1/13/839/001, EU/1/13/839/002, EU/1/13/839/003, EU/1/13/839/004, 1.7.2013, EU (94) 3.7.2028
1973545 13C0069 France   Start Trial PRODUCT NAME: PONATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, SOLVATE OU HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
1973545 92327 Luxembourg   Start Trial PRODUCT NAME: PONATINIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE
1973545 122013000152 Germany   Start Trial PRODUCT NAME: PONATINIB "BENZAMID, 3-(2-IMIDAZO(1,2-B)PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-(4-((4-METHYL-1-PIPERAZINYL)METHYL)-3-(TRIFLUORMETHYL)PHENYL)"; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
1973545 490 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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