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Ponatinib hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ponatinib hydrochloride?

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.

This ingredient has sixty patent family members in eighteen countries.

One supplier is listed for this compound.

Summary for Generic Name: ponatinib hydrochloride

Tradenames:1
Patents:4
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packagers: see list1
Bulk Api Vendors: see list3
Clinical Trials: see list998
Patent Applications: see list3
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ponatinib hydrochloride at DailyMed

Pharmacology for Ingredient: ponatinib hydrochloride

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-002Dec 14, 2012RXYesYes9,029,533► Subscribe ► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-001Dec 14, 2012RXYesNo8,114,874► SubscribeYY ► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-001Dec 14, 2012RXYesNo9,029,533► Subscribe ► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-002Dec 14, 2012RXYesYes► Subscribe► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-002Dec 14, 2012RXYesYes► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,778,942Substituted acetylenic imidazo[1,2-A]pyrazine compounds as kinase inhibitors► Subscribe
9,090,561Acetylenic heteroaryl compounds► Subscribe
9,278,971Substituted acetylenic pyrazolo[1,5-a]pyrimidines as kinase inhibitors► Subscribe
8,278,307Monocyclic Heteroaryl compounds► Subscribe
8,470,851Substituted acetylenic imidazo[1,2-A]pyridine compounds as kinase inhibitors► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: ponatinib hydrochloride

Country Document Number Estimated Expiration
Japan2015147796► Subscribe
Eurasian Patent Organization200870116► Subscribe
South Korea20090018942► Subscribe
Cyprus1113907► Subscribe
Japan5273037► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: PONATINIB HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90059-2Sweden► SubscribePRODUCT NAME: PONATINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT, SOLVAT ELLER HYDRAT DAERAV; REG. NO/DATE: EU/1/13/839/001 20130701
00631Netherlands► SubscribePRODUCT NAME: PONATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, SOLVAAT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
1973545/01Switzerland► SubscribePRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: SWISSMEDIC 63097 12.02.2014
2013 00066Denmark► SubscribePRODUCT NAME: PONATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF INCLUDING THE HYDROCHLORIDE SALT THEREOF; REG. NO/DATE: EU/1/13/839/001-004 20130701
327Luxembourg► SubscribePRODUCT NAME: PONATINIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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