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Serving leading biopharmaceutical companies globally:

Covington
Federal Trade Commission
Healthtrust
Dow
Harvard Business School
Accenture
Teva
Colorcon
Deloitte
Farmers Insurance

Generated: February 19, 2018

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 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-seven patent family members in nineteen countries.

Two suppliers are listed for this compound.
Summary for ponatinib hydrochloride
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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-002 Dec 14, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-001 Dec 14, 2012 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-003 Apr 23, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-001 Dec 14, 2012 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-003 Apr 23, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-002 Dec 14, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-003 Apr 23, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-002 Dec 14, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ariad ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-001 Dec 14, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
8,278,307 Monocyclic Heteroaryl compounds ➤ Sign Up
8,778,942 Substituted acetylenic imidazo[1,2-A]pyrazine compounds as kinase inhibitors ➤ Sign Up
9,090,561 Acetylenic heteroaryl compounds ➤ Sign Up
9,278,971 Substituted acetylenic pyrazolo[1,5-a]pyrimidines as kinase inhibitors ➤ Sign Up
8,461,167 Acetylenic heteroaryl compounds ➤ Sign Up
8,470,851 Substituted acetylenic imidazo[1,2-A]pyridine compounds as kinase inhibitors ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for ponatinib hydrochloride

Supplementary Protection Certificates for ponatinib hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90059-2 Sweden ➤ Sign Up PRODUCT NAME: PONATINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT, SOLVAT ELLER HYDRAT DAERAV; REG. NO/DATE: EU/1/13/839/001 20130701
1973545/01 Switzerland ➤ Sign Up PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: SWISSMEDIC 63097 12.02.2014
2013027,C1973545 Lithuania ➤ Sign Up PRODUCT 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
2013027 Lithuania ➤ Sign Up PRODUCT 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
2013 00066 Denmark ➤ Sign Up PRODUCT NAME: PONATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF INCLUDING THE HYDROCHLORIDE SALT THEREOF; REG. NO/DATE: EU/1/13/839/001-004 20130701
00631 Netherlands ➤ Sign Up PRODUCT NAME: PONATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, SOLVAAT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
13/059 Ireland ➤ Sign Up PRODUCT NAME: PONATINIB IN ALL FORMS PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
0 Finland ➤ Sign Up
1 5025-2013 Slovakia ➤ Sign Up (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
327 Luxembourg ➤ Sign Up PRODUCT NAME: PONATINIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Accenture
Federal Trade Commission
Farmers Insurance
Mallinckrodt
Cantor Fitzgerald
Express Scripts
Fuji
Medtronic

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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