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Generated: January 24, 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 ponatinib hydrochloride freedom to operate?

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 sixty-eight patent family members in nineteen countries.

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

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
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 (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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-003 Apr 23, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-002 Dec 14, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-001 Dec 14, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-002 Dec 14, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-003 Apr 23, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 ponatinib hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/059 Ireland ➤ Sign Up PRODUCT NAME: PONATINIB IN ALL FORMS PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
2013027 Lithuania ➤ Sign Up PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: EU/1/13/839/001, 2013 07 01 EU/1/13/839/002, 2013 07 01 EU/1/13/839/003, 2013 07 01 EU/1/13/839/004 20130701
2013 00066 Denmark ➤ Sign Up PRODUCT NAME: PONATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF INCLUDING THE HYDROCHLORIDE SALT THEREOF; REG. NO/DATE: EU/1/13/839/001-004 20130701
0 Finland ➤ Sign Up
2013 00066 Denmark ➤ Sign Up PRODUCT NAME: POATINIB, HERUNDER PONATINIB HYDROCHLORID; REG. NO/DATE: EU/1/13/839/001-004 20130701
0130033 00093 Estonia ➤ Sign Up PRODUCT NAME: PONATINIIB;REG NO/DATE: K(2013)4238 (LOPLIK) 01.07.2013
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Citi
Farmers Insurance
Cerilliant
Harvard Business School
Cantor Fitzgerald
Argus Health
Federal Trade Commission
Covington

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