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Last Updated: August 14, 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 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-six patent family members in twenty-three countries.

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

Summary for PONATINIB HYDROCHLORIDE
Recent Clinical Trials for PONATINIB HYDROCHLORIDE

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

SponsorPhase
Otsuka Beijing Research InstitutePhase 2
Incyte Biosciences UKPhase 2
Fundacion CRIS de Investigación para Vencer el CáncerPhase 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 203469-001 Dec 14, 2012 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   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 203469-002 Dec 14, 2012 RX Yes Yes   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 72/2013 Austria   Start Trial PRODUCT NAME: PONATINIB; REGISTRATION NO/DATE: EU/1/13/839 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
1973545 CA 2013 00066 Denmark   Start Trial PRODUCT NAME: POATINIB, HERUNDER PONATINIB HYDROCHLORID; REG. NO/DATE: EU/1/13/839/001-004 20130701
1973545 C 2013 039 Romania   Start Trial PRODUCT NAME: PONATINIB SI SARURILE SALE ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/839/001, EU/1/13/839/002, EU/1/13/839/003, EU/1/13/839/004; DATE OF NATIONAL AUTHORISATION: 20130701; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/839/001, EU/1/13/839/002, EU/1/13/839/003, EU/1/13/839/004; DATE OF FIRST AUTHORISATION IN EEA: 20130701
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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