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Last Updated: January 22, 2021

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XOSPATA Drug Profile

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Which patents cover Xospata, and what generic alternatives are available?

Xospata is a drug marketed by Astellas and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-seven patent family members in twenty-eight countries.

The generic ingredient in XOSPATA is gilteritinib fumarate. One supplier is listed for this compound. Additional details are available on the gilteritinib fumarate profile page.

US ANDA Litigation and Generic Entry Outlook for Xospata

Xospata will be eligible for patent challenges on November 28, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 1, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for XOSPATA
Drug patent expirations by year for XOSPATA
Drug Prices for XOSPATA

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Generic Entry Opportunity Date for XOSPATA
Generic Entry Date for XOSPATA*:
Constraining patent/regulatory exclusivity:
NDA:
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 XOSPATA

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

SponsorPhase
National Cancer Institute (NCI)Phase 3
Children's Oncology GroupPhase 3
M.D. Anderson Cancer CenterPhase 1/Phase 2

See all XOSPATA clinical trials

US Patents and Regulatory Information for XOSPATA

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 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 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
>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 XOSPATA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2428508 8/2020 Austria   Start Trial PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 (MITTEILUNG) 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 PA2020002 Lithuania   Start Trial PRODUCT NAME: GILTERITINIBAS; REGISTRATION NO/DATE: EU/1/19/1399 20191024
2428508 2020/004 Ireland   Start Trial PRODUCT NAME: GILTERITINIB OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1399 20191024
2428508 CA 2020 00006 Denmark   Start Trial PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/19/1399 20191028
2428508 301028 Netherlands   Start Trial PRODUCT NAME: GILTERITINIB OF EEN ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/19/13177 20191028
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:

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Mallinckrodt

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.