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Last Updated: March 8, 2021

DrugPatentWatch Database Preview

Gilteritinib fumarate - Generic Drug Details

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What are the generic drug sources for gilteritinib fumarate and what is the scope of freedom to operate?

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 patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for gilteritinib fumarate
International Patents:60
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 5
Clinical Trials: 3
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   Start Trial   Start Trial   Start Trial
Astellas XOSPATA gilteritinib fumarate TABLET;ORAL 211349-001 Nov 28, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Astellas XOSPATA gilteritinib fumarate TABLET;ORAL 211349-001 Nov 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astellas XOSPATA gilteritinib fumarate TABLET;ORAL 211349-001 Nov 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astellas XOSPATA gilteritinib fumarate TABLET;ORAL 211349-001 Nov 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for gilteritinib fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2428508 C202030004 Spain   Start Trial 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 2020C/502 Belgium   Start Trial PRODUCT NAME: GILTERITINIB OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1399 20191028
2428508 LUC00147 Luxembourg   Start Trial PRODUCT NAME: GILTERITINIB OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1399 20191028
2428508 2090007-2 Sweden   Start Trial PRODUCT NAME: GILTERITINIB OR A SALT THEROF; REG. NO/DATE: EU/1/19/1399 20191028
2428508 PA2020002,C2428508 Lithuania   Start Trial PRODUCT NAME: GILTERITINIBAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/19/1399 20191024
2428508 132020000000016 Italy   Start Trial PRODUCT NAME: GILTERITINIB E SUOI SALI(XOSPATA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1399, 20191028
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
AstraZeneca
Baxter
McKinsey
Moodys

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.