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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 sixty patent family members in twenty-nine countries.
One supplier is listed for this compound.
Summary for gilteritinib fumarate
| International Patents: | 60 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 5 |
| Clinical Trials: | 3 |
| DailyMed Link: | gilteritinib fumarate at DailyMed |
Recent Clinical Trials for gilteritinib fumarate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 1 |
| City of Hope Medical Center | Phase 1 |
| National Cancer Institute (NCI) | Phase 3 |
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 | Start Trial | Start Trial | Start Trial | ||||
| Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 | Estimated Expiration |
|---|---|---|
| Mexico | 2017016862 | Start Trial |
| Japan | 2017119728 | Start Trial |
| Hong Kong | 1248544 | Start Trial |
| Hungary | E026647 | Start Trial |
| Japan | 6132294 | Start Trial |
| Slovenia | 3009428 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for gilteritinib fumarate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2428508 | C202030004 | Spain | Start Trial | 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 | 2020C/502 | Belgium | Start Trial | PRODUCT NAME: GILTERITINIB OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1399 20191028 |
| 2428508 | LUC00147 | Luxembourg | Start Trial | PRODUCT NAME: GILTERITINIB OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1399 20191028 |
| 2428508 | 2090007-2 | Sweden | Start Trial | PRODUCT NAME: GILTERITINIB OR A SALT THEROF; REG. NO/DATE: EU/1/19/1399 20191028 |
| 2428508 | PA2020002,C2428508 | Lithuania | Start Trial | PRODUCT NAME: GILTERITINIBAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/19/1399 20191024 |
| 2428508 | 132020000000016 | Italy | Start Trial | 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 |
