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PONATINIB HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for ponatinib hydrochloride and what is the scope of patent protection?

Ponatinib hydrochloride is the generic ingredient in one branded drug marketed by Ariad and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ponatinib hydrochloride has seventy-six patent family members in twenty-one countries.

There is one drug master file entry for ponatinib hydrochloride. Two suppliers are listed for this compound.

Summary for PONATINIB HYDROCHLORIDE

International Patents:	76
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	15
Clinical Trials:	45
Patent Applications:	11
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PONATINIB HYDROCHLORIDE
DailyMed Link:	PONATINIB HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PONATINIB HYDROCHLORIDE

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

Sponsor	Phase
Centre Leon Berard	Phase 2
Incyte Biosciences International Sàrl	Phase 1/Phase 2
Fundación Teófilo Hernando, Spain	Phase 2

See all PONATINIB HYDROCHLORIDE clinical trials

Recent Litigation for PONATINIB HYDROCHLORIDE

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Ariad Pharmaceuticals, Inc. v. Matal

See all PONATINIB HYDROCHLORIDE litigation

Pharmacology for PONATINIB HYDROCHLORIDE

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Synonyms for PONATINIB HYDROCHLORIDE

1114544-31-8

3-(2-(Imidazo(1,2-b)pyridazin-3-yl)ethynyl)-4-methyl-N-(4-((4-methylpiperazin-1- yl)methyl)-3-(trifluoromethyl)phenyl)benzamide monohydrochloride

3-(2-{imidazo[1,2-b]pyridazin-3-yl}ethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide hydrochloride

3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-(4-((4-methylpiperazin-1-yl)methyl)-3-(trifluoromethyl)phenyl)benzamide hydrochloride

96R6PU3D8J

AKOS030621539

AOB3899

AP 24534 hydrochloride

AP-24534 HCl

AP24534 HCL

AP24534 Hydrochloride

AS-16772

BCP10906

Benzamide, 3-(2-imidazo(1,2-b)pyridazin-3-ylethynyl)-4-methyl-N-(4-((4-methyl-1- piperazinyl)methyl)-3-(trifluoromethyl)phenyl)-, hydrochloride (1:1)

BWTNNZPNKQIADY-UHFFFAOYSA-N

C29H28ClF3N6O

CHEMBL2105708

D09951

DTXSID50149655

Iclusig

Iclusig (TN)

Ponatinib (HCl salt)

Ponatinib HCl

Ponatinib hydrochloride (JAN/USAN)

Ponatinib hydrochloride [USAN]

Ponatinib Mono-hydrochloride

SCHEMBL15798559

UNII-96R6PU3D8J

Y1466

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

International Patents for PONATINIB HYDROCHLORIDE

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007075869
Israel	229351
Israel	239445
Japan	6447508
Israel	229350
Canada	2815506

Supplementary Protection Certificates for PONATINIB HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1973545	PA2013027,C1973545	Lithuania		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	C01973545/01	Switzerland		PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: SWISSMEDIC 63097 12.02.2014
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	151 5025-2013	Slovakia		(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	C300631	Netherlands		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
1973545	13C0069	France		PRODUCT NAME: PONATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, SOLVATE OU HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701