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Last Updated: February 28, 2021

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 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
Associazione Italiana Pazienti Leucemia Mieloide CronicaPhase 2
Cardiff UniversityPhase 2
TakedaPhase 1/Phase 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 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 203469-002 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 122013000152 Germany   Start Trial PRODUCT NAME: PONATINIB "BENZAMID, 3-(2-IMIDAZO(1,2-B)PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-(4-((4-METHYL-1-PIPERAZINYL)METHYL)-3-(TRIFLUORMETHYL)PHENYL)"; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
1973545 C20130033 00093 Estonia   Start Trial PRODUCT NAME: PONATINIIB;REG NO/DATE: K(2013)4238 (LOPLIK) 01.07.2013
1973545 2013C/073 Belgium   Start Trial PRODUCT NAME: PONATINIB; AUTHORISATION NUMBER AND DATE: EU/1/13/839/001 20130703
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Colorcon
Medtronic
Dow
Johnson and Johnson

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