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: | 10 |
| Patent Applications: | 179 |
| 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
*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 ⤷ 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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ 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 | |||
| 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
Patent: COMPOSITION PHARMACEUTIQUE STABLE POUR UNE ADMINISTRATION ORALE (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Croatia
Patent: 0230253
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 18259
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 18259
Patent: COMPOSITION PHARMACEUTIQUE STABLE POUR ADMINISTRATION PAR VOIE ORALE (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Patent: 30208
Patent: COMPOSITION PHARMACEUTIQUE STABLE POUR ADMINISTRATION ORALE (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 18259
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Hungary
Patent: 61697
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 2017006855
Patent: 安定な経口投与用医薬組成物
Estimated Expiration: ⤷ Sign Up
Patent: 32294
Estimated Expiration: ⤷ Sign Up
Patent: 98400
Estimated Expiration: ⤷ Sign Up
Patent: 17119728
Patent: 安定な経口投与用医薬組成物 (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 18259
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 17016862
Patent: COMPOSICION FARMACEUTICA ESTABLE PARA ADMINISTRACION ORAL. (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINSITRATION.)
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 017502252
Patent: STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 18259
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 18259
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 64750
Patent: СТАБИЛЬНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Patent: 18103354
Patent: СТАБИЛЬНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 070
Patent: STABILNA FARMACEUTSKA KOMPOZICIJA ZA ORALNU ADMINISTRACIJU (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 18259
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 180023914
Patent: 안정된 경구 투여용 의약 조성물
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 40306
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 56177
Estimated Expiration: ⤷ Sign Up
Patent: 1716069
Patent: Stable pharmaceutical composition for oral administration
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 |
|---|---|---|---|
| Cyprus | 1120367 | ⤷ Sign Up | |
| Denmark | 3318259 | ⤷ Sign Up | |
| Hungary | S000511 | ⤷ Sign Up | |
| Poland | 3318259 | ⤷ Sign Up | |
| Taiwan | I484961 | ⤷ Sign Up | |
| Finland | 3318259 | ⤷ 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 | LUC00147 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: GILTERITINIB OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND 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 | 132020000000016 | Italy | ⤷ Sign Up | PRODUCT NAME: GILTERITINIB E SUOI SALI(XOSPATA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1399, 20191028 |
| 2428508 | 8/2020 | Austria | ⤷ Sign Up | PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 (MITTEILUNG) 20191028 |
| 2428508 | SPC/GB20/007 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: GILTERITINIB OR A SALT THEREOF; REGISTERED: UK EU/1/19/1399(FOR NI) 20191028; UK PLGB00166/0425 20191028 |
| 2428508 | 2020001 | Norway | ⤷ Sign Up | PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAV; REG. NO/DATE: EU/1/19/1399 20191030 |
| >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.
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