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-seven 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
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for XOSPATA?
- What are the global sales for XOSPATA?
- What is Average Wholesale Price for XOSPATA?
Summary for XOSPATA
International Patents: | 77 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 78 |
Clinical Trials: | 10 |
Patent Applications: | 146 |
Drug Prices: | Drug price information for XOSPATA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XOSPATA |
What excipients (inactive ingredients) are in XOSPATA? | XOSPATA excipients list |
DailyMed Link: | XOSPATA at DailyMed |


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
Sponsor | Phase |
---|---|
Kura Oncology, Inc. | Phase 1 |
Acute Leukemia French Association | Phase 2 |
French Innovative Leukemia Organisation | Phase 2 |
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 ⤷ Try for Free.
This potential generic entry date is based on patent 10,786,500.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 9,487,491 | ⤷ Try for Free | ⤷ Try for Free | ||||
Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | 11,938,131 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | 11,938,130 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | 11,938,132 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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
Patent: COMPOSITION PHARMACEUTIQUE STABLE POUR ADMINISTRATION PAR VOIE ORALE (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷ Try for Free
China
Patent: 7847500
Patent: 稳定的口服给药用药物组合物 (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINSITRATION)
Estimated Expiration: ⤷ Try for Free
Croatia
Patent: 0230253
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 18259
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 18259
Patent: COMPOSITION PHARMACEUTIQUE STABLE POUR ADMINISTRATION PAR VOIE ORALE (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷ Try for Free
Patent: 30208
Patent: COMPOSITION PHARMACEUTIQUE STABLE POUR ADMINISTRATION ORALE (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷ Try for Free
Finland
Patent: 18259
Estimated Expiration: ⤷ Try for Free
Hong Kong
Patent: 48544
Patent: 穩定的口服給藥用藥物組合物 (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷ Try for Free
Hungary
Patent: 61697
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 2017006855
Patent: 安定な経口投与用医薬組成物
Estimated Expiration: ⤷ Try for Free
Patent: 32294
Estimated Expiration: ⤷ Try for Free
Patent: 98400
Estimated Expiration: ⤷ Try for Free
Patent: 17119728
Patent: 安定な経口投与用医薬組成物 (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷ Try for Free
Lithuania
Patent: 18259
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 17016862
Patent: COMPOSICION FARMACEUTICA ESTABLE PARA ADMINISTRACION ORAL. (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINSITRATION.)
Estimated Expiration: ⤷ Try for Free
Philippines
Patent: 017502252
Patent: STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 18259
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 18259
Estimated Expiration: ⤷ Try for Free
Russian Federation
Patent: 64750
Patent: СТАБИЛЬНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷ Try for Free
Patent: 18103354
Patent: СТАБИЛЬНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ
Estimated Expiration: ⤷ Try for Free
Serbia
Patent: 070
Patent: STABILNA FARMACEUTSKA KOMPOZICIJA ZA ORALNU ADMINISTRACIJU (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 18259
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 2685890
Estimated Expiration: ⤷ Try for Free
Patent: 180023914
Patent: 안정된 경구 투여용 의약 조성물
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 40306
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 56177
Estimated Expiration: ⤷ Try for Free
Patent: 1716069
Patent: Stable pharmaceutical composition for oral administration
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
Norway | 3009428 | ⤷ Try for Free | |
Mexico | 2017016862 | COMPOSICION FARMACEUTICA ESTABLE PARA ADMINISTRACION ORAL. (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINSITRATION.) | ⤷ Try for Free |
Luxembourg | C00147 | ⤷ Try for Free | |
Portugal | 3009428 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XOSPATA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2428508 | 8/2020 | Austria | ⤷ Try for Free | PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 (MITTEILUNG) 20191028 |
2428508 | C202030004 | Spain | ⤷ Try for Free | 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 | PA2020002 | Lithuania | ⤷ Try for Free | PRODUCT NAME: GILTERITINIBAS; REGISTRATION NO/DATE: EU/1/19/1399 20191024 |
2428508 | 122020000004 | Germany | ⤷ Try for Free | PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 20191024 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Xospata
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