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Last Updated: March 29, 2024

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 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:3
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 14
Clinical Trials: 3
Patent Applications: 85
DailyMed Link:gilteritinib fumarate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for gilteritinib fumarate
Generic Entry Date for gilteritinib fumarate*:
Constraining patent/regulatory exclusivity:
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

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

See all gilteritinib fumarate clinical trials

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

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astellas XOSPATA gilteritinib fumarate TABLET;ORAL 211349-001 Nov 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astellas XOSPATA gilteritinib fumarate TABLET;ORAL 211349-001 Nov 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astellas XOSPATA gilteritinib fumarate TABLET;ORAL 211349-001 Nov 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>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
Hungary E061697 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2017006855 ⤷  Try a Trial
South Korea 20180023914 안정된 경구 투여용 의약 조성물 ⤷  Try a Trial
Russian Federation 2011149799 ДИАМИНОГЕТЕРОЦИКЛИЧЕСКОЕ КАРБОКСАМИДНОЕ СОЕДИНЕНИЕ ⤷  Try a Trial
Russian Federation 2018103354 СТАБИЛЬНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for gilteritinib fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2428508 CR 2020 00006 Denmark ⤷  Try a Trial PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/19/1399 20191028
2428508 SPC/GB20/007 United Kingdom ⤷  Try a Trial PRODUCT NAME: GILTERITINIB OR A SALT THEREOF; REGISTERED: UK EU/1/19/1399(FOR NI) 20191028; UK PLGB00166/0425 20191028
2428508 C202030004 Spain ⤷  Try a 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 2020/004 Ireland ⤷  Try a Trial PRODUCT NAME: GILTERITINIB OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1399 20191024
2428508 301028 Netherlands ⤷  Try a Trial 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.