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Last Updated: May 18, 2021

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Ponatinib hydrochloride - Generic Drug Details

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What are the generic sources for ponatinib hydrochloride and what is the scope of 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 eighty-eight patent family members in twenty-three countries.

There is one drug master file entry for ponatinib hydrochloride. One supplier is listed for this compound.

Recent Clinical Trials for ponatinib hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of ChicagoPhase 2
Gruppo Italiano Malattie EMatologiche dell'AdultoPhase 3
Associazione Italiana Pazienti Leucemia Mieloide CronicaPhase 2

See all ponatinib hydrochloride clinical trials

Pharmacology for ponatinib hydrochloride
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

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   Get Started Free   Get Started Free Y Y   Get Started Free
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-001 Dec 14, 2012 RX Yes No   Get Started Free   Get Started Free Y Y   Get Started Free
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-004 Dec 18, 2020 RX Yes No   Get Started Free   Get Started Free Y Y   Get Started Free
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-001 Dec 14, 2012 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-004 Dec 18, 2020 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-002 Dec 14, 2012 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
>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 490 Finland   Get Started Free
1973545 CR 2013 00066 Denmark   Get Started Free 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 1390059-2 Sweden   Get Started Free PERIOD OF VALIDITY (FROM - UNTIL): 20261223 - 20280702
1973545 SPC/GB13/077 United Kingdom   Get Started Free PRODUCT NAME: PONATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, SOLVATE OR HYDRATE THEREOF; REGISTERED: UK EU/1/13/839/001 20130703; UK EU/1/13/839/002 20130703; UK EU/1/13/839/003 20130703; UK EU/1/13/839/004 20130703
1973545 C01973545/01 Switzerland   Get Started Free PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: SWISSMEDIC 63097 12.02.2014
1973545 151 5025-2013 Slovakia   Get Started Free (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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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McKesson

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