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 three patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-four patent family members in twenty-nine 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
Summary for XOSPATA
| International Patents: | 64 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 57 |
| Clinical Trials: | 8 |
| Patent Applications: | 259 |
| Drug Prices: | Drug price information for XOSPATA |
| What excipients (inactive ingredients) are in XOSPATA? | XOSPATA excipients list |
| DailyMed Link: | XOSPATA at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity 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 |
|---|---|
| Gerhard C Hildebrandt | Phase 1 |
| Astellas Pharma Inc | Phase 1 |
| Erasca, Inc. | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for XOSPATA
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 three US patents and two FDA Regulatory Exclusivities.
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
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
NEW CHEMICAL ENTITY
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 | ⤷ Sign Up | ||||
| Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | 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
Denmark
Patent: 18259
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 18259
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 48544
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
Mexico
Patent: 17016862
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 017502252
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 64750
Estimated Expiration: ⤷ Sign Up
Patent: 18103354
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 180023914
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 |
|---|---|---|---|
| Hungary | S000511 | ⤷ Sign Up | |
| Hong Kong | 1219105 | 二氨基雜環甲酰胺化合物 (DIAMINO HETEROCYCLIC CARBOXAMIDE COMPOUND) | ⤷ Sign Up |
| Luxembourg | C00147 | ⤷ 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 | CA 2020 00006 | Denmark | ⤷ Sign Up | PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/19/1399 20191028 |
| 2428508 | CR 2020 00006 | Denmark | ⤷ Sign Up | PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/19/1399 20191028 |
| 2428508 | 132020000000016 | Italy | ⤷ Sign Up | 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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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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