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ICLUSIG Drug Profile

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Which patents cover Iclusig, and what substitute generic drugs are available?

Iclusig is a drug marketed by Ariad and is included in one NDA. There are three patents protecting this drug.

This drug has sixty patent family members in eighteen countries.

The generic ingredient in ICLUSIG is ponatinib hydrochloride. One supplier is listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.

Summary for Tradename: ICLUSIG

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list58
Clinical Trials: see list11
Patent Applications: see list43
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ICLUSIG at DailyMed

Pharmacology for Tradename: ICLUSIG

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, 2012RXYesYes8,114,874► SubscribeYY ► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-002Dec 14, 2012RXYesYes► Subscribe► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-001Dec 14, 2012RXYesNo9,029,533► Subscribe ► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-003Apr 23, 2015RXYesNo► Subscribe► Subscribe
Ariad
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL203469-001Dec 14, 2012RXYesNo8,114,874► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Tradename: ICLUSIG

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
9,278,971Substituted acetylenic pyrazolo[1,5-a]pyrimidines as kinase inhibitors► Subscribe
8,461,167Acetylenic heteroaryl compounds► Subscribe
9,090,561Acetylenic heteroaryl compounds► Subscribe
8,778,942Substituted acetylenic imidazo[1,2-A]pyrazine 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 Tradename: ICLUSIG

Country Document Number Estimated Expiration
Canada2650273► Subscribe
China101489558► Subscribe
Cyprus1113907► Subscribe
BrazilPI0710331► Subscribe
Japan2009536650► 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: ICLUSIG

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/059Ireland► SubscribePRODUCT NAME: PONATINIB IN ALL FORMS PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
1973545/01Switzerland► SubscribePRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: SWISSMEDIC 63097 12.02.2014
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
90059-2Sweden► SubscribePRODUCT NAME: PONATINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT, SOLVAT ELLER HYDRAT DAERAV; REG. NO/DATE: EU/1/13/839/001 20130701
0130033 00093Estonia► SubscribePRODUCT NAME: PONATINIIB;REG NO/DATE: K(2013)4238 (LOPLIK) 01.07.2013
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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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