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Serving leading biopharmaceutical companies globally:

UBS
Daiichi Sankyo
Covington
Moodys
Mallinckrodt
Argus Health
McKinsey
McKesson
Julphar
Colorcon

Generated: November 24, 2017

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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 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-six patent family members in nineteen countries and fourteen supplementary protection certificates in twelve countries.

Two suppliers are listed for this compound.

Pharmacology for ponatinib hydrochloride

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
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;ORAL203469-002Dec 14, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-001Dec 14, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-003Apr 23, 2015RXYesNo► Subscribe► Subscribe ► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-003Apr 23, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-003Apr 23, 2015RXYesNo► Subscribe► SubscribeYY ► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-003Apr 23, 2015RXYesNo► Subscribe► SubscribeYY ► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-001Dec 14, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-001Dec 14, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-002Dec 14, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-003Apr 23, 2015RXYesNo► Subscribe► 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
8,278,307Monocyclic Heteroaryl compounds► Subscribe
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
8,470,851Substituted acetylenic imidazo[1,2-A]pyridine compounds as kinase inhibitors► Subscribe
8,461,167Acetylenic heteroaryl compounds► 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
Japan2009536650► Subscribe
China103435595► Subscribe
Denmark1973545► Subscribe
Japan2009536652► Subscribe
European Patent Office2495016► Subscribe
World Intellectual Property Organization (WIPO)2007133562► Subscribe
Eurasian Patent Organization200870514► Subscribe
BrazilPI0710328► Subscribe
BrazilPI0710331► Subscribe
Eurasian Patent Organization200870515► 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
1 5025-2013Slovakia► Subscribe(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
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
13/059Ireland► SubscribePRODUCT NAME: PONATINIB IN ALL FORMS PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
2013000152Germany► SubscribePRODUCT 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
2013027Lithuania► SubscribePRODUCT 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
C0069France► SubscribePRODUCT NAME: PONATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, SOLVATE OU HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
2013027,C1973545Lithuania► SubscribePRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: EU/1/13/839/001, 2013 07 03 EU/1/13/839/002, 2013 07 03 EU/1/13/839/003, 2013 07 03 EU/1/13/839/004 20130703
1973545/01Switzerland► SubscribePRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: SWISSMEDIC 63097 12.02.2014
0130033 00093Estonia► SubscribePRODUCT NAME: PONATINIIB;REG NO/DATE: K(2013)4238 (LOPLIK) 01.07.2013
2013 00066Denmark► SubscribePRODUCT NAME: POATINIB, HERUNDER PONATINIB HYDROCHLORID; REG. NO/DATE: EU/1/13/839/001-004 20130701
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Serving leading biopharmaceutical companies globally:

Baxter
Argus Health
McKesson
Moodys
Cipla
Queensland Health
Chubb
AstraZeneca
Medtronic
Accenture

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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