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Last Updated: May 26, 2022

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 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

SponsorPhase
National Cancer Institute (NCI)Phase 1
City of Hope Medical CenterPhase 1
National Cancer Institute (NCI)Phase 3

See all gilteritinib fumarate clinical trials

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astellas XOSPATA gilteritinib fumarate TABLET;ORAL 211349-001 Nov 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astellas XOSPATA gilteritinib fumarate TABLET;ORAL 211349-001 Nov 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astellas XOSPATA gilteritinib fumarate TABLET;ORAL 211349-001 Nov 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astellas XOSPATA gilteritinib fumarate TABLET;ORAL 211349-001 Nov 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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

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

Supplementary Protection Certificates for gilteritinib fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2428508 CA 2020 00006 Denmark See Plans and Pricing PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/19/1399 20191028
2428508 2020001 Norway See Plans and Pricing PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAV; REG. NO/DATE: EU/1/19/1399 20191030
2428508 C20200003 00314 Estonia See Plans and Pricing PRODUCT NAME: GILTERITINIIB;REG NO/DATE: EU/1/19/1399 28.10.2019
2428508 C202030004 Spain See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: GILTERITINIB OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1399 20191028
2428508 20C1003 France See Plans and Pricing PRODUCT NAME: GILTERITINIB OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/19/1399 20191028
2428508 8/2020 Austria See Plans and Pricing PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 (MITTEILUNG) 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.