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ICLUSIG Drug Profile

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

Iclusig is a drug marketed by Ariad and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-eight 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.

Indicators of Generic Entry

Summary for ICLUSIG

International Patents:	88
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	23
Patent Applications:	1,750
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

See drug prices for ICLUSIG

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for ICLUSIG

NDA:

203469

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
Associazione Italiana Pazienti Leucemia Mieloide Cronica	Phase 2
CZECRIN - Czech Clinical Research Infrastructure Network	Phase 2

See all ICLUSIG clinical trials

Pharmacology for ICLUSIG

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

US Patents and Regulatory Information for ICLUSIG

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	203469-002	Dec 14, 2012		RX	Yes	Yes
Ariad	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-004	Dec 18, 2020		RX	Yes	No
Ariad	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-001	Dec 14, 2012		RX	Yes	No
Ariad	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-002	Dec 14, 2012		RX	Yes	Yes
Ariad	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-004	Dec 18, 2020		RX	Yes	No			Y	Y
Ariad	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-003	Apr 23, 2015		RX	Yes	No

International Patents for ICLUSIG

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	200870116
Luxembourg	92327
China	103467385
European Patent Office	3747441
Slovenia	1973545
Mexico	2015007578

Supplementary Protection Certificates for ICLUSIG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1973545	122013000152	Germany		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	Lithuania		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
1973545	CR 2013 00066	Denmark		PRODUCT NAME: PONATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF INCLUDING THE HYDROCHLORIDE SALT THEREOF; REG. NO/DATE: EU/1/13/839/001-004 20130701
1973545	2013C/073	Belgium		PRODUCT NAME: PONATINIB; AUTHORISATION NUMBER AND DATE: EU/1/13/839/001 20130703
1973545	CA 2013 00066	Denmark		PRODUCT NAME: POATINIB, HERUNDER PONATINIB HYDROCHLORID; REG. NO/DATE: EU/1/13/839/001-004 20130701
1973545	72/2013	Austria		PRODUCT NAME: PONATINIB; REGISTRATION NO/DATE: EU/1/13/839 20130701