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Last Updated: April 18, 2024

PONATINIB HYDROCHLORIDE - Generic Drug Details

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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.

Ponatinib hydrochloride has one hundred and four patent family members in twenty-three countries.

There is one drug master file entry for ponatinib hydrochloride. One supplier is listed for this compound.

Summary for PONATINIB HYDROCHLORIDE

International Patents:	104
US Patents:	6
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	61
Patent Applications:	658
Formulation / Manufacturing:	see details
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

Recent Clinical Trials for PONATINIB HYDROCHLORIDE

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

Sponsor	Phase
Institute of Hematology & Blood Diseases Hospital	Phase 2
University of Michigan Rogel Cancer Center	Phase 2
University of Chicago	Phase 2

See all PONATINIB HYDROCHLORIDE clinical trials

Pharmacology for PONATINIB HYDROCHLORIDE

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-004	Dec 18, 2020		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-001	Dec 14, 2012		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-001	Dec 14, 2012		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-004	Dec 18, 2020		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	PONATINIB HYDROCHLORIDE	ponatinib hydrochloride	TABLET;ORAL	215893-001	Jul 14, 2023		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-002	Dec 14, 2012		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-003	Apr 23, 2015		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for PONATINIB HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Japan	2009521462		⤷ Try a Trial
Denmark	1973545		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2014093579		⤷ Try a Trial
Canada	2650273	COMPOSES D'HETEROARYLE MONOCYCLIQUE (MONOCYCLIC HETEROARYL COMPOUNDS)	⤷ Try a Trial
Luxembourg	92327		⤷ Try a Trial
European Patent Office	3747441	COMPOSANTS HÉTÉROARYLES BICYCLIQUES (BICYCLIC HETEROARYL COMPOUNDS)	⤷ Try a Trial
South Korea	20090018104	ACETYLENIC HETEROARYL COMPOUNDS	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PONATINIB HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1973545	1390059-2	Sweden	⤷ Try a Trial	PERIOD OF VALIDITY (FROM - UNTIL): 20261223 - 20280702
1973545	C300631	Netherlands	⤷ Try a Trial	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	72/2013	Austria	⤷ Try a Trial	PRODUCT NAME: PONATINIB; REGISTRATION NO/DATE: EU/1/13/839 20130701
1973545	151 5025-2013	Slovakia	⤷ Try a Trial	(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	C01973545/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: SWISSMEDIC 63097 12.02.2014
1973545	CR 2013 00066	Denmark	⤷ Try a Trial	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	C20130033 00093	Estonia	⤷ Try a Trial	PRODUCT NAME: PONATINIIB;REG NO/DATE: K(2013)4238 (LOPLIK) 01.07.2013
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.