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Last Updated: April 22, 2024

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 six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and four 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.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ICLUSIG
Drug Prices for ICLUSIG

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Recent Clinical Trials for ICLUSIG

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

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

See all ICLUSIG clinical trials

Pharmacology for ICLUSIG
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for ICLUSIG
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ICLUSIG Tablets ponatinib hydrochloride 10 mg and 30 mg 203469 1 2022-12-12
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 seventeen US patents.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA

Substituted acetylenic imidazo[1,2-B]pyridazine compounds as kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA

Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR THE TREATMENT OF LEUKEMIAS

Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA

Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Takeda Pharms Usa ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-001 Dec 14, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Takeda Pharms Usa ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-004 Dec 18, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Patent: 16210725
Estimated Expiration: ⤷  Try a Trial

Patent: 18201013
Estimated Expiration: ⤷  Try a Trial

Patent: 19240721
Estimated Expiration: ⤷  Try a Trial

Patent: 21221493
Estimated Expiration: ⤷  Try a Trial

Patent: 23219845
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 15506
Estimated Expiration: ⤷  Try a Trial

Patent: 22250
Estimated Expiration: ⤷  Try a Trial

Patent: 67093
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 15001643
Estimated Expiration: ⤷  Try a Trial

China

Patent: 5188701
Estimated Expiration: ⤷  Try a Trial

Patent: 5043843
Patent: 3-(咪唑并[1,2-B]哒嗪-3-基乙炔基)-4-甲基-N{4-[(4-甲基哌嗪-1-基)甲基]-3-(三氟甲基)苯基}苯甲酰胺和它的单盐酸盐的晶形 (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 monohydrochloride)
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 18878
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 47508
Estimated Expiration: ⤷  Try a Trial

Patent: 42175
Estimated Expiration: ⤷  Try a Trial

Patent: 52841
Estimated Expiration: ⤷  Try a Trial

Patent: 16503010
Estimated Expiration: ⤷  Try a Trial

Patent: 18168191
Estimated Expiration: ⤷  Try a Trial

Patent: 22037122
Estimated Expiration: ⤷  Try a Trial

Patent: 23179498
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 9147
Estimated Expiration: ⤷  Try a Trial

Patent: 15007578
Estimated Expiration: ⤷  Try a Trial

Patent: 21002253
Estimated Expiration: ⤷  Try a Trial

Patent: 21002254
Estimated Expiration: ⤷  Try a Trial

Patent: 21002255
Estimated Expiration: ⤷  Try a Trial

Patent: 21002256
Estimated Expiration: ⤷  Try a Trial

Patent: 21002257
Estimated Expiration: ⤷  Try a Trial

Patent: 21002258
Estimated Expiration: ⤷  Try a Trial

Patent: 21002259
Estimated Expiration: ⤷  Try a Trial

Patent: 21002261
Estimated Expiration: ⤷  Try a Trial

Patent: 21002264
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 9648
Estimated Expiration: ⤷  Try a Trial

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
Poland 2495016 ⤷  Try a Trial
Mexico 2015007578 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.) ⤷  Try a Trial
Canada 2651822 COMPOSES D'HETEROARYLE ACETYLENIQUE (ACETYLENIC HETEROARYL COMPOUNDS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ICLUSIG

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1973545 C01973545/01 Switzerland ⤷  Try a Trial PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: SWISSMEDIC 63097 12.02.2014
1973545 490 Finland ⤷  Try a Trial
1973545 C300631 Netherlands ⤷  Try a Trial 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
>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.