GILTERITINIB FUMARATE - Generic Drug Details
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What are the generic drug sources for gilteritinib fumarate and what is the scope of freedom to operate?
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 seventy-five patent family members in thirty-one countries.
One supplier is listed for this compound.
Summary for GILTERITINIB FUMARATE
International Patents: | 75 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 14 |
Clinical Trials: | 3 |
Patent Applications: | 85 |
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 |
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 | ⤷ 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 | ⤷ 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 |
---|---|---|---|
Canada | 2760061 | COMPOSE DE CARBOXAMIDE HETEROCYCLIQUE DIAMINO (DIAMINO HETEROCYCLIC CARBOXAMIDE COMPOUND) | ⤷ Try a Trial |
Japan | 5364159 | ⤷ Try a Trial | |
China | 102421761 | Diamino heterocyclic carboxamide compound | ⤷ 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 | 132020000000016 | Italy | ⤷ Try a Trial | PRODUCT NAME: GILTERITINIB E SUOI SALI(XOSPATA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1399, 20191028 |
2428508 | 301028 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: GILTERITINIB OF EEN ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/19/13177 20191028 |
2428508 | C02428508/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: GILTERITINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67211 24.09.2020 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |