PONATINIB HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for ponatinib hydrochloride and what is the scope of freedom to operate?

Ponatinib hydrochloride is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa and Apotex, and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for PONATINIB HYDROCHLORIDE

International Patents:	109
US Patents:	6
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	70
Patent Applications:	1,578
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PONATINIB HYDROCHLORIDE
What excipients (inactive ingredients) are in PONATINIB HYDROCHLORIDE?	PONATINIB HYDROCHLORIDE excipients list
DailyMed Link:	PONATINIB HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PONATINIB HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ ALL)

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 PONATINIB HYDROCHLORIDE

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

Sponsor	Phase
Takeda	PHASE2
University of Washington	PHASE2
University of Alberta	PHASE2

See all PONATINIB HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for PONATINIB HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 15MG BASE	TABLET;ORAL
		EQ 45MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for PONATINIB HYDROCHLORIDE

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PONATINIB HYDROCHLORIDE

L01EA	BCR-ABL tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for PONATINIB HYDROCHLORIDE

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 PONATINIB HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	PONATINIB HYDROCHLORIDE	ponatinib hydrochloride	TABLET;ORAL	215893-002	Jul 14, 2023		DISCN	No	No
Apotex	PONATINIB HYDROCHLORIDE	ponatinib hydrochloride	TABLET;ORAL	215893-001	Jul 14, 2023		DISCN	No	No
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-003	Apr 23, 2015		RX	Yes	No	11,192,897			Y
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-003	Apr 23, 2015		RX	Yes	No	11,192,895
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-002	Dec 14, 2012		RX	Yes	No
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-004	Dec 18, 2020		RX	Yes	Yes	8,114,874		Y	Y
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-003	Apr 23, 2015		RX	Yes	No	11,384,086		Y	Y

International Patents for PONATINIB HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Australia	2013204506	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
Australia	2016210725	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
Australia	2018201013	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
Australia	2019240721	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
Australia	2021221493	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
Australia	2023219845
Australia	2025204582	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

Supplementary Protection Certificates for PONATINIB HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	CA 2013 00066	Denmark		PRODUCT NAME: POATINIB, HERUNDER PONATINIB HYDROCHLORID; REG. NO/DATE: EU/1/13/839/001-004 20130701
1973545	92327	Luxembourg		PRODUCT NAME: PONATINIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE
1973545	C01973545/01	Switzerland		FUSION; FORMER OWNER: ARIAD PHARMACEUTICALS, INC., US
1973545	C 2013 039	Romania		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	C20130033 00093	Estonia		PRODUCT NAME: PONATINIIB;REG NO/DATE: K(2013)4238 (LOPLIK) 01.07.2013