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Generated: May 23, 2018

DrugPatentWatch Database Preview

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.
Summary for ponatinib hydrochloride
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 203469-002 Dec 14, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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 203469-001 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
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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Non-Orange Book US Patents for ponatinib hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,470,851 Substituted acetylenic imidazo[1,2-A]pyridine compounds as kinase inhibitors ➤ Try a Free Trial
8,278,307 Monocyclic Heteroaryl compounds ➤ Try a Free Trial
9,278,971 Substituted acetylenic pyrazolo[1,5-a]pyrimidines as kinase inhibitors ➤ Try a Free Trial
9,090,561 Acetylenic heteroaryl compounds ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ponatinib hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/059 Ireland ➤ Try a Free Trial PRODUCT NAME: PONATINIB IN ALL FORMS PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
2013027 Lithuania ➤ Try a Free Trial 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
0 Finland ➤ Try a Free Trial
90059-2 Sweden ➤ Try a Free Trial PRODUCT NAME: PONATINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT, SOLVAT ELLER HYDRAT DAERAV; REG. NO/DATE: EU/1/13/839/001 20130701
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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