XOSPATA Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Xospata, and when can generic versions of Xospata launch?
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 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
Summary for XOSPATA
International Patents: | 75 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 78 |
Clinical Trials: | 8 |
Patent Applications: | 247 |
Drug Prices: | Drug price information 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 |
---|---|
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 one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of XOSPATA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Diamino heterocyclic carboxamide compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Diamino heterocyclic carboxamide compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>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: ⤷ Try a Trial
China
Patent: 7847500
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0230253
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 18259
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 18259
Estimated Expiration: ⤷ Try a Trial
Patent: 30208
Estimated Expiration: ⤷ Try a Trial
Finland
Patent: 18259
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 48544
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 61697
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 2017006855
Estimated Expiration: ⤷ Try a Trial
Patent: 32294
Estimated Expiration: ⤷ Try a Trial
Patent: 98400
Estimated Expiration: ⤷ Try a Trial
Patent: 17119728
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 18259
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 17016862
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 017502252
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 18259
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 18259
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 64750
Estimated Expiration: ⤷ Try a Trial
Patent: 18103354
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 070
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 18259
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 180023914
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 40306
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 56177
Estimated Expiration: ⤷ Try a Trial
Patent: 1716069
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Slovenia | 3318259 | ⤷ Try a Trial | |
Lithuania | 3318259 | ⤷ Try a Trial | |
Spain | 2940306 | ⤷ Try a Trial | |
Brazil | PI1011838 | composto de carboxamida heterocĂclica de diamino | ⤷ Try a Trial |
>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 a Trial | PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 (MITTEILUNG) 20191028 |
2428508 | CR 2020 00006 | Denmark | ⤷ Try a Trial | PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/19/1399 20191028 |
2428508 | 132020000000016 | Italy | ⤷ Try a Trial | PRODUCT NAME: GILTERITINIB E SUOI SALI(XOSPATA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1399, 20191028 |
2428508 | PA2020002,C2428508 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: GILTERITINIBAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/19/1399 20191024 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |