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
Summary for ICLUSIG
International Patents: | 90 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 117 |
Clinical Trials: | 25 |
Patent Applications: | 2,449 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ICLUSIG |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ICLUSIG |
What excipients (inactive ingredients) are in ICLUSIG? | ICLUSIG excipients list |
DailyMed Link: | ICLUSIG at DailyMed |


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
Sponsor | Phase |
---|---|
University of Chicago | Phase 2 |
CZECRIN - Czech Clinical Research Infrastructure Network | Phase 2 |
Institute of Hematology and Blood Transfusion, Czech Republic | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for ICLUSIG
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
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 |