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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 ponatinib hydrochloride 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-four patent family members in twenty countries.

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

Summary for PONATINIB HYDROCHLORIDE

International Patents:	74
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	15
Clinical Trials:	42
Patent Applications:	10
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PONATINIB HYDROCHLORIDE
DailyMed Link:	PONATINIB HYDROCHLORIDE at DailyMed

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	203469-001	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
Ariad	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-002	Dec 14, 2012		RX	Yes	Yes

International Patents for PONATINIB HYDROCHLORIDE

Country	Patent Number	Estimated Expiration
South Korea	101436303
Japan	2016503010
Eurasian Patent Organization	201790678
Japan	2015147796

Supplementary Protection Certificates for PONATINIB HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	2013C/073	Belgium		PRODUCT NAME: PONATINIB; AUTHORISATION NUMBER AND DATE: EU/1/13/839/001 20130703