Gilteritinib fumarate - Generic Drug Details

What are the generic sources for gilteritinib fumarate and what is the scope of patent protection?

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

Gilteritinib fumarate has sixty-two patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for gilteritinib fumarate

International Patents:	62
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	3
Patent Applications:	45
DailyMed Link:	gilteritinib fumarate at DailyMed

Recent Clinical Trials for gilteritinib fumarate

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1
City of Hope Medical Center	Phase 1
National Cancer Institute (NCI)	Phase 3

See all gilteritinib fumarate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for gilteritinib fumarate

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for gilteritinib fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes			Y
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes			Y	Y

International Patents for gilteritinib fumarate

Country	Patent Number	Title	Estimated Expiration
China	102421761	Diamino heterocyclic carboxamide compound
Taiwan	201716069	Stable pharmaceutical composition for oral administration
European Patent Office	3318259	COMPOSITION PHARMACEUTIQUE STABLE POUR ADMINISTRATION PAR VOIE ORALE (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Serbia	57045	JEDINJENJE DIAMINO HETEROCIKLIČNOG KARBOKSAMIDA (DIAMINO HETEROCYCLIC CARBOXAMIDE COMPOUND)
Japan	5364159
Russian Federation	2764750	СТАБИЛЬНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Taiwan	I484961

Supplementary Protection Certificates for gilteritinib fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2428508	CA 2020 00006	Denmark		PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/19/1399 20191028
2428508	2020001	Norway		PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAV; REG. NO/DATE: EU/1/19/1399 20191030
2428508	C20200003 00314	Estonia		PRODUCT NAME: GILTERITINIIB;REG NO/DATE: EU/1/19/1399 28.10.2019
2428508	C202030004	Spain		PRODUCT NAME: GILTERITINIB O UNA SAL DEL MISMO NOMBRE; NATIONAL AUTHORISATION NUMBER: EU/1/19/1399; DATE OF AUTHORISATION: 20191024; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1399; DATE OF FIRST AUTHORISATION IN EEA: 20191024
2428508	LUC00147	Luxembourg		PRODUCT NAME: GILTERITINIB OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1399 20191028
2428508	20C1003	France		PRODUCT NAME: GILTERITINIB OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/19/1399 20191028
2428508	8/2020	Austria		PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 (MITTEILUNG) 20191028