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Last Updated: June 14, 2024

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XOSPATA Drug Patent 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 eight patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-five patent family members in thirty-one 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.

DrugPatentWatch® Generic Entry Outlook for Xospata

Xospata was eligible for patent challenges on November 28, 2022.

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.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for XOSPATA
International Patents:75
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 78
Clinical Trials: 8
Patent Applications: 179
Drug Prices: Drug price information for XOSPATA
What excipients (inactive ingredients) are in XOSPATA?XOSPATA excipients list
DailyMed Link:XOSPATA at DailyMed
Drug patent expirations by year for XOSPATA
Drug Prices for XOSPATA

See drug prices for XOSPATA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Gerhard C HildebrandtPhase 1
Astellas Pharma IncPhase 1
Erasca, Inc.Phase 1/Phase 2

See all XOSPATA clinical trials

Paragraph IV (Patent) Challenges for XOSPATA
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 XOSPATA

XOSPATA is protected by eight US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XOSPATA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XOSPATA

Stable pharmaceutical composition for oral administration
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Patent Expiration: ⤷  Sign Up


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Patent Number: ⤷  Sign Up
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Diamino heterocyclic carboxamide compound
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Diamino heterocyclic carboxamide compound
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE MYELOID LEUKEMIA (AML)

FDA Regulatory Exclusivity protecting XOSPATA

INDICATED FOR THE TREATMENT OF ADULT PATIENTS WHO HAVE RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A FMS-LIKE TYROSINE KINASE 3 (FLT3) MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷  Sign Up

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

When does loss-of-exclusivity occur for XOSPATA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Patent: 89534
Estimated Expiration: ⤷  Sign Up

China

Patent: 7847500
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0230253
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 18259
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 18259
Estimated Expiration: ⤷  Sign Up

Patent: 30208
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 18259
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 48544
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 61697
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 2017006855
Estimated Expiration: ⤷  Sign Up

Patent: 32294
Estimated Expiration: ⤷  Sign Up

Patent: 98400
Estimated Expiration: ⤷  Sign Up

Patent: 17119728
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 18259
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 17016862
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 017502252
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 18259
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 18259
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 64750
Estimated Expiration: ⤷  Sign Up

Patent: 18103354
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 070
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 18259
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 180023914
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 40306
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 56177
Estimated Expiration: ⤷  Sign Up

Patent: 1716069
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XOSPATA around the world.

Country Patent Number Title Estimated Expiration
Serbia 57045 JEDINJENJE DIAMINO HETEROCIKLIČNOG KARBOKSAMIDA (DIAMINO HETEROCYCLIC CARBOXAMIDE COMPOUND) ⤷  Sign Up
European Patent Office 4230208 COMPOSITION PHARMACEUTIQUE STABLE POUR ADMINISTRATION ORALE (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION) ⤷  Sign Up
Netherlands 301028 ⤷  Sign Up
France 20C1003 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XOSPATA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2428508 2020/004 Ireland ⤷  Sign Up PRODUCT NAME: GILTERITINIB OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1399 20191024
2428508 20C1003 France ⤷  Sign Up PRODUCT NAME: GILTERITINIB OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/19/1399 20191028
2428508 C202030004 Spain ⤷  Sign Up 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 2090007-2 Sweden ⤷  Sign Up PRODUCT NAME: GILTERITINIB OR A SALT THEROF; REG. NO/DATE: EU/1/19/1399 20191028
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.