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Last Updated: November 24, 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
CZECRIN - Czech Clinical Research Infrastructure NetworkPhase 2
Institute of Hematology and Blood Transfusion, Czech RepublicPhase 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 and two FDA Regulatory Exclusivities.

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
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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
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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
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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
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Patent Expiration: ⤷  Sign Up
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
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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
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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
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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
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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
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Patented Use: A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA

Substituted acetylenic imidazo[1,2-B]pyridazine compounds as kinase inhibitors
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Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors
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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
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Patented Use: A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA

Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors
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Patented Use: A METHOD FOR THE TREATMENT OF LEUKEMIAS

Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors
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Patented Use: A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA

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

FDA Regulatory Exclusivity protecting ICLUSIG

TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ ALL) IN COMBINATION WITH CHEMOTHERAPY
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ ALL)
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Takeda Pharms Usa ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-003 Apr 23, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Takeda Pharms Usa ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-002 Dec 14, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Takeda Pharms Usa ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-003 Apr 23, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Takeda Pharms Usa ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469-001 Dec 14, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Patent: Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide mono hydrochloride
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Patent: 16210725
Patent: Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide mono hydrochloride
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Patent: 18201013
Patent: Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide mono hydrochloride
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Patent: 19240721
Patent: Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide mono hydrochloride
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Patent: 21221493
Patent: Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide mono hydrochloride
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Patent: 23219845
Patent: Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N- {4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide mono hydrochloride
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 15506
Patent: FORMES CRISTALLINES DE 3-(IMIDAZO[1,2-B]PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-{4-[(4-METHYLPIPERAZ IN-1-YL)METHYL]-3-(TRIFLUOROMETHYL)PHENYL}BENZAMIDE MONO HYDROCHLORIDE (CRYSTALLINE FORMS OF 3-(IMIDAZO[1,2-B]PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-{4-[(4-METHYLPIPERAZIN-1-YL)METHYL]-3-(TRIFLUOROMETHYL)PHENYL}BENZAMIDE MONO HYDROCHLORIDE)
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Patent: 22250
Patent: FORMES CRISTALLINES DE 3-(IMIDAZO[1,2-B]PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-{4-[(4-METHYLPIPERAZ IN-1-YL)METHYL]-3-(TRIFLUOROMETHYL)PHENYL}BENZAMIDE MONO HYDROCHLORIDE (CRYSTALLINE FORMS OF 3-(IMIDAZO[1,2-B]PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-{4-[(4-METHYLPIPERAZIN-1-YL)METHYL]-3-(TRIFLUOROMETHYL)PHENYL}BENZAMIDE MONO HYDROCHLORIDE)
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Patent: 67093
Patent: FORME CRISTALLINE C DU MONOCHLORHYDRATE DE BENZAMIDE A FONCTION 3-(IMIDAZO[1,2-B]PYRIDAZINE-3-YLETHYNYL)-4-METHYLE-N-{4-[(4-METHYLPIPERAZINE-1-YL)METHYLE)3(TRIFLUOROMETHYLE)PHENYLE} (CRYSTALLINE FORM C OF 3-(IMIDAZO[1,2-B]PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-{4-[(4-METHYLPIPERAZIN-1-YL)METHYL)-3-(TRIFLUOROMETHYL)PHENYL}BENZAMIDE MONO HYDROCHLORIDE)
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Chile

Patent: 15001643
Patent: Formas cristalinas de 3-(imidazo[1,2-b]piridazin-3-iletinil)-4-metil-n-{4-[(4-metilpiperazin-1-il)metil]-3-(trifluorometil)fenil}benzamida y su sal monoclorhidrato; composicion farmaceutica que las comprende; proceso para preparar la forma cristalina a; y metodo para tratar leucemias seleccionadas de la cml o la ph+ aal.
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China

Patent: 5188701
Patent: 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
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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)
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Hong Kong

Patent: 18878
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Japan

Patent: 47508
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Patent: 42175
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Patent: 52841
Estimated Expiration: ⤷  Sign Up

Patent: 16503010
Patent: 3−(イミダゾ[1,2−b]ピリダジン−3−イルエチニル)−4−メチル−N−{4−[(4−メチルピペラジン−1−イル)メチル]−3−(トリフルオロメチル)フェニル}ベンズアミドおよびその一塩酸塩の結晶形
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Patent: 18168191
Patent: 3−(イミダゾ[1,2−b]ピリダジン−3−イルエチニル)−4−メチル−N−{4−[(4−メチルピペラジン−1−イル)メチル]−3−(トリフルオロメチル)フェニル}ベンズアミドおよびその一塩酸塩の結晶形 (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 SALTS)
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Patent: 22037122
Patent: 3-(イミダゾ[1,2-b]ピリダジン-3-イルエチニル)-4-メチル-N-{4-[(4-メチルピペラジン-1-イル)メチル]-3-(トリフルオロメチル)フェニル}ベンズアミドおよびその一塩酸塩の結晶形
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Patent: 23179498
Patent: 3-(イミダゾ[1,2-b]ピリダジン-3-イルエチニル)-4-メチル-N-{4-[(4-メチルピペラジン-1-イル)メチル]-3-(トリフルオロメチル)フェニル}ベンズアミドおよびその一塩酸塩の結晶形 (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 SALTS)
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Mexico

Patent: 9147
Patent: 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.)
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Patent: 15007578
Patent: 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.)
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Patent: 21002253
Patent: FORMAS CRISTALINAS DE 3-(IMIDAZO[1,2-B] PIRIDAZIN-3- ILETINIL)-4-METIL-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.)
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Patent: 21002254
Patent: FORMAS CRISTALINAS DE 3-(IMIDAZO[1,2-B] PIRIDAZIN-3- ILETINIL)-4-METIL-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.)
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Patent: 21002255
Patent: FORMAS CRISTALINAS DE 3-(IMIDAZO[1,2-B] PIRIDAZIN-3- ILETINIL)-4-METIL-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.)
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Patent: 21002256
Patent: FORMAS CRISTALINAS DE 3-(IMIDAZO[1,2-B] PIRIDAZIN-3- ILETINIL)-4-METIL-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.)
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Patent: 21002257
Patent: FORMAS CRISTALINAS DE 3-(IMIDAZO[1,2-B] PIRIDAZIN-3- ILETINIL)-4-METIL-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.)
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Patent: 21002258
Patent: FORMAS CRISTALINAS DE 3-(IMIDAZO[1,2-B] PIRIDAZIN-3- ILETINIL)-4-METIL-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.)
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Patent: 21002259
Patent: FORMAS CRISTALINAS DE 3-(IMIDAZO[1,2-B] PIRIDAZIN-3- ILETINIL)-4-METIL-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.)
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Patent: 21002261
Patent: FORMAS CRISTALINAS DE 3-(IMIDAZO[1,2-B] PIRIDAZIN-3- ILETINIL)-4-METIL-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.)
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Patent: 21002264
Patent: FORMAS CRISTALINAS DE 3-(IMIDAZO[1,2-B] PIRIDAZIN-3- ILETINIL)-4-METIL-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.)
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New Zealand

Patent: 9648
Patent: 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
Estimated Expiration: ⤷  Sign Up

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 3417912 COMPOSANTS HÉTÉROAROMATIQUES BICYCLIQUES (BICYCLIC HETEROARYL COMPOUNDS) ⤷  Sign Up
Japan 5200939 ⤷  Sign Up
Spain 2555515 ⤷  Sign Up
Portugal 1973545 ⤷  Sign Up
Canada 2650273 COMPOSES D'HETEROARYLE MONOCYCLIQUE (MONOCYCLIC HETEROARYL COMPOUNDS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ICLUSIG

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1973545 122013000152 Germany ⤷  Sign Up 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
1973545 PA2013027,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
1973545 72/2013 Austria ⤷  Sign Up PRODUCT NAME: PONATINIB; REGISTRATION NO/DATE: EU/1/13/839 20130701
1973545 2013C/073 Belgium ⤷  Sign Up PRODUCT NAME: PONATINIB; AUTHORISATION NUMBER AND DATE: EU/1/13/839/001 20130703
1973545 C300631 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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