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-two patent family members in twenty-nine countries.
One supplier is listed for this compound.
Summary for gilteritinib fumarate
| International Patents: | 62 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 9 |
| Clinical Trials: | 3 |
| Patent Applications: | 45 |
| DailyMed Link: | gilteritinib fumarate at DailyMed |
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 |
| Children's Oncology Group | 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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >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 |
|---|---|---|---|
| Serbia | 54552 | JEDINJENJE DIAMINO HETEROCIKLIČNOG KARBOKSAMIDA (DIAMINO HETEROCYCLIC CARBOXAMIDE COMPOUND) | See Plans and Pricing |
| European Patent Office | 2428508 | COMPOSÉ DE CARBOXAMIDE HÉTÉROCYCLIQUE DIAMINO (DIAMINO HETEROCYCLIC CARBOXAMIDE COMPOUND) | See Plans and Pricing |
| Cyprus | 1120367 | See Plans and Pricing | |
| Australia | 2010245545 | Diamino heterocyclic carboxamide compound | See Plans and Pricing |
| Japan | WO2010128659 | ジアミノへテロ環カルボキサミド化合物 | See Plans and Pricing |
| >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 | See Plans and Pricing | PRODUCT NAME: GILTERITINIIB;REG NO/DATE: EU/1/19/1399 28.10.2019 |
| 2428508 | PA2020002 | Lithuania | See Plans and Pricing | PRODUCT NAME: GILTERITINIBAS; REGISTRATION NO/DATE: EU/1/19/1399 20191024 |
| 2428508 | 2020/004 | Ireland | See Plans and Pricing | PRODUCT NAME: GILTERITINIB OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1399 20191024 |
| 2428508 | 2090007-2 | Sweden | See Plans and Pricing | PRODUCT NAME: GILTERITINIB OR A SALT THEROF; REG. NO/DATE: EU/1/19/1399 20191028 |
| 2428508 | 20C1003 | France | See Plans and Pricing | PRODUCT NAME: GILTERITINIB OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/19/1399 20191028 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
