Ponatinib hydrochloride - Generic Drug Details

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What are the generic 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:	62
Patent Applications:	517
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
German Federal Ministry of Education and Research	Phase 2
Deutsche Leukämie- & Lymphom-Hilfe	Phase 2
Goethe University	Phase 2

See all ponatinib hydrochloride clinical trials

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

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-002	Dec 14, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-004	Dec 18, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-003	Apr 23, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-001	Dec 14, 2012		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-004	Dec 18, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Apotex	PONATINIB HYDROCHLORIDE	ponatinib hydrochloride	TABLET;ORAL	215893-001	Jul 14, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
China	115043843	3-(咪唑并[1,2-B]哒嗪-3-基乙炔基)-4-甲基-N{4-[(4-甲基哌嗪-1-基)甲基]-3-(三氟甲基)苯基}苯甲酰胺和它的单盐酸盐的晶形 (Crystalline forms of 3-(imidazo [1, 2-b] pyridazin-3-ylethynyl)-4-methyl-n {4-[(4-methylpiperazin-1-yl) methyl]-3-(trifluoromethyl) phenyl} benzamide and its monohydrochloride)	⤷ Sign Up
South Korea	20080081191	BICYCLIC HETEROARYL COMPOUNDS	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2007075869		⤷ Sign Up
Japan	2022037122	３－（イミダゾ［１，２－ｂ］ピリダジン－３－イルエチニル）－４－メチル－Ｎ－｛４－［（４－メチルピペラジン－１－イル）メチル］－３－（トリフルオロメチル）フェニル｝ベンズアミドおよびその一塩酸塩の結晶形	⤷ Sign Up
China	105188701	Crystalline forms of 3-(imidazo[1,2-b] pyridazin-3-ylethynyl)-4-methyl-n-(4-[(4-methylpiperazin-1-yl) methyl]-3-(trifluoromethyl)phenyl)benzamide and its mono hydrochloride salt	⤷ Sign Up
Cyprus	1113907		⤷ Sign Up
Japan	5200939		⤷ Sign Up
>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	SPC/GB13/077	United Kingdom	⤷ Sign Up	PRODUCT NAME: PONATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, SOLVATE OR HYDRATE THEREOF; REGISTERED: UK EU/1/13/839/001 20130703; UK EU/1/13/839/002 20130703; UK EU/1/13/839/003 20130703; UK EU/1/13/839/004 20130703
1973545	C 2013 039	Romania	⤷ Sign Up	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	CA 2013 00066	Denmark	⤷ Sign Up	PRODUCT NAME: POATINIB, HERUNDER PONATINIB HYDROCHLORID; REG. NO/DATE: EU/1/13/839/001-004 20130701
1973545	C20130033 00093	Estonia	⤷ Sign Up	PRODUCT NAME: PONATINIIB;REG NO/DATE: K(2013)4238 (LOPLIK) 01.07.2013
1973545	PA2013027	Lithuania	⤷ Sign Up	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	151 5025-2013	Slovakia	⤷ Sign Up	(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	⤷ Sign Up	PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: SWISSMEDIC 63097 12.02.2014
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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