Gilteritinib fumarate - Generic Drug Details

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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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Gilteritinib fumarate has seventy-five patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for gilteritinib fumarate

International Patents:	75
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	3
Patent Applications:	85
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for gilteritinib fumarate
DailyMed Link:	gilteritinib fumarate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for gilteritinib fumarate

Generic Entry Date for gilteritinib fumarate^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for gilteritinib fumarate

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

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

Paragraph IV (Patent) Challenges for GILTERITINIB FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XOSPATA	Tablets	gilteritinib fumarate	40 mg	211349	1	2022-11-28

US Patents and Regulatory Information for gilteritinib fumarate

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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
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
>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 gilteritinib fumarate

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Country	Patent Number	Title	Estimated Expiration
South Africa	201108642	DIAMINO HETEROCYCLIC CARBOXAMIDE COMPOUND	⤷ Subscribe
Mexico	2011011875	COMPUESTO DE CARBOXAMIDA HETEROCICLICA DIAMINO. (DIAMINO HETEROCYCLIC CARBOXAMIDE COMPOUND.)	⤷ Subscribe
Croatia	P20230253		⤷ Subscribe
Slovenia	3009428		⤷ Subscribe
Portugal	2428508		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for gilteritinib fumarate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2428508	PA2020002,C2428508	Lithuania	⤷ Subscribe	PRODUCT NAME: GILTERITINIBAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/19/1399 20191024
2428508	C02428508/01	Switzerland	⤷ Subscribe	PRODUCT NAME: GILTERITINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67211 24.09.2020
2428508	C202030004	Spain	⤷ Subscribe	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	132020000000016	Italy	⤷ Subscribe	PRODUCT NAME: GILTERITINIB E SUOI SALI(XOSPATA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1399, 20191028
2428508	301028	Netherlands	⤷ Subscribe	PRODUCT NAME: GILTERITINIB OF EEN ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/19/13177 20191028
>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.