Gilteritinib fumarate - Generic Drug Details
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What are the generic sources for gilteritinib fumarate and what is the scope of patent protection?
Gilteritinib fumarate
is the generic ingredient in one branded drug marketed by Astellas and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Gilteritinib fumarate has sixty-four patent family members in twenty-nine countries.
One supplier is listed for this compound.
Summary for gilteritinib fumarate
International Patents: | 64 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 12 |
Clinical Trials: | 3 |
Patent Applications: | 79 |
DailyMed Link: | gilteritinib fumarate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for gilteritinib fumarate
Generic Entry Date for gilteritinib fumarate*:
Constraining patent/regulatory exclusivity:
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 gilteritinib fumarate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
City of Hope Medical Center | Phase 1 |
National Cancer Institute (NCI) | Phase 1 |
National Cancer Institute (NCI) | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for gilteritinib fumarate
Paragraph IV (Patent) Challenges for GILTERITINIB FUMARATE
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 gilteritinib fumarate
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 | Y | ⤷ 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 | ⤷ 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 | 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 gilteritinib fumarate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2667706 | ⤷ Try a Trial | |
Japan | 6132294 | ⤷ Try a Trial | |
Poland | 3009428 | ⤷ Try a Trial | |
Spain | 2559230 | ⤷ Try a Trial | |
Brazil | PI1011838 | composto de carboxamida heterocĂclica de diamino | ⤷ Try a Trial |
China | 102421761 | Diamino heterocyclic carboxamide compound | ⤷ Try a Trial |
Canada | 2989534 | COMPOSITION PHARMACEUTIQUE STABLE POUR UNE ADMINISTRATION ORALE (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for gilteritinib fumarate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2428508 | C20200003 00314 | Estonia | ⤷ Try a Trial | PRODUCT NAME: GILTERITINIIB;REG NO/DATE: EU/1/19/1399 28.10.2019 |
2428508 | 8/2020 | Austria | ⤷ Try a Trial | PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 (MITTEILUNG) 20191028 |
2428508 | PA2020002 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: GILTERITINIBAS; REGISTRATION NO/DATE: EU/1/19/1399 20191024 |
2428508 | 301028 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: GILTERITINIB OF EEN ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/19/13177 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 | LUC00147 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: GILTERITINIB OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1399 20191028 |
2428508 | CA 2020 00006 | Denmark | ⤷ Try a Trial | PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/19/1399 20191028 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |