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Last Updated: May 24, 2022

ICLUSIG Drug Patent Profile


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When do Iclusig patents expire, and what generic alternatives are available?

Iclusig is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has ninety patent family members in twenty-three countries.

The generic ingredient in ICLUSIG is ponatinib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Iclusig

Iclusig was eligible for patent challenges on December 14, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 12, 2033. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for ICLUSIG
Drug Prices for ICLUSIG

See drug prices for ICLUSIG

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ICLUSIG
Generic Entry Date for ICLUSIG*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ICLUSIG

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of ChicagoPhase 2
CZECRIN - Czech Clinical Research Infrastructure NetworkPhase 2
Institute of Hematology and Blood Transfusion, Czech RepublicPhase 2

See all ICLUSIG clinical trials

Paragraph IV (Patent) Challenges for ICLUSIG
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ICLUSIG Tablets ponatinib hydrochloride 15 mg and 45 mg 203469 1 2021-03-31

US Patents and Regulatory Information for ICLUSIG

ICLUSIG is protected by fourteen US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ICLUSIG is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ICLUSIG

Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-n-{4-[(4-methylpiperazin- -1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA

Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-n-{4-[(4-methylpiperazin- -1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN

Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-n-{4-[(4-methylpiperazin- -1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA

Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin- -1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA

Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin- -1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN

Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin- -1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA

Substituted acetylenic imidazo[1,2-B]pyridazine compounds as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN

Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA

Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR THE TREATMENT OF LEUKEMIAS

Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA

Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA

Crystalline forms of 3-(imidazo[1,2-B] pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl) methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA

Crystalline forms of 3-(imidazo[1,2-B] pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl) methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA

FDA Regulatory Exclusivity protecting ICLUSIG

CHRONIC PHASE (CP) CHRONIC MYELOID LEUKEMIA (CML) WITH RESISTANCE OR INTOLERANCE TO AT LEAST TWO PRIOR KINASE INHIBITORS
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-003 Apr 23, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-002 Dec 14, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-003 Apr 23, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-003 Apr 23, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Takeda Pharms Usa ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-001 Dec 14, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Takeda Pharms Usa ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-004 Dec 18, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-002 Dec 14, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ICLUSIG

When does loss-of-exclusivity occur for ICLUSIG?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 13204506
Estimated Expiration: See Plans and Pricing

Patent: 16210725
Estimated Expiration: See Plans and Pricing

Patent: 18201013
Estimated Expiration: See Plans and Pricing

Patent: 19240721
Estimated Expiration: See Plans and Pricing

Patent: 21221493
Estimated Expiration: See Plans and Pricing

Canada

Patent: 15506
Estimated Expiration: See Plans and Pricing

Patent: 22250
Estimated Expiration: See Plans and Pricing

Chile

Patent: 15001643
Estimated Expiration: See Plans and Pricing

China

Patent: 5188701
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 18878
Estimated Expiration: See Plans and Pricing

Japan

Patent: 47508
Estimated Expiration: See Plans and Pricing

Patent: 16503010
Estimated Expiration: See Plans and Pricing

Patent: 18168191
Estimated Expiration: See Plans and Pricing

Patent: 22037122
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 9147
Estimated Expiration: See Plans and Pricing

Patent: 15007578
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9648
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ICLUSIG around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 3747441 COMPOSANTS HÉTÉROARYLES BICYCLIQUES (BICYCLIC HETEROARYL COMPOUNDS) See Plans and Pricing
Hungary E047422 See Plans and Pricing
Mexico 359147 FORMAS CRISTALINAS DE 3-(IMIDAZO[1,2-B] PIRIDAZIN-3-ILETINIL)-4-ME TIL-N-(4-[ (4-METILPIPERAZIN-1-IL) METIL]-3-(TRIFLUOROMETIL) FENIL) BENZAMIDA Y SU SAL DE MONOCLORHIDRATO. (CRYSTALLINE FORMS OF 3-(IMIDAZO[1,2-B] PYRIDAZIN-3-YLETHYNYL)-4-M ETHYL-N-(4-[(4-METHYLPIPERAZIN-1-YL) METHYL]-3-(TRIFLUOROMETHYL)P HENYL)BENZAMIDE AND ITS MONO HYDROCHLORIDE SALT.) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2014093579 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2007075869 See Plans and Pricing
Hungary S1300078 See Plans and Pricing
South Korea 101436303 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ICLUSIG

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1973545 1390059-2 Sweden See Plans and Pricing PERIOD OF VALIDITY (FROM - UNTIL): 20261223 - 20280702
1973545 C20130033 00093 Estonia See Plans and Pricing PRODUCT NAME: PONATINIIB;REG NO/DATE: K(2013)4238 (LOPLIK) 01.07.2013
1973545 2013/059 Ireland See Plans and Pricing PRODUCT NAME: PONATINIB IN ALL FORMS PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
1973545 490 Finland See Plans and Pricing
1973545 C 2013 039 Romania See Plans and Pricing PRODUCT NAME: PONATINIB SI SARURILE SALE ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/839/001, EU/1/13/839/002, EU/1/13/839/003, EU/1/13/839/004; DATE OF NATIONAL AUTHORISATION: 20130701; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/839/001, EU/1/13/839/002, EU/1/13/839/003, EU/1/13/839/004; DATE OF FIRST AUTHORISATION IN EEA: 20130701
1973545 151 5025-2013 Slovakia See Plans and Pricing (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
1973545 122013000152 Germany See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.