Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: December 7, 2019

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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-six 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
Centre Leon BerardPhase 2
Incyte Biosciences International SàrlPhase 1/Phase 2
Fundación Teófilo Hernando, SpainPhase 2

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Recent Litigation for PONATINIB HYDROCHLORIDE

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

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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 203469-002 Dec 14, 2012 RX Yes Yes   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   Start Trial
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 203469-001 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 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 C01973545/01 Switzerland   Start Trial PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: SWISSMEDIC 63097 12.02.2014
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 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 C300631 Netherlands   Start Trial PRODUCT NAME: PONATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, SOLVAAT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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.