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Gilteritinib fumarate - Generic Drug Details
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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Gilteritinib fumarate has forty patent family members in twenty-six countries.
One supplier is listed for this compound.
Summary for gilteritinib fumarate
| International Patents: | 40 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 4 |
| Clinical Trials: | 1 |
| 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/Phase 2 |
| M.D. Anderson Cancer Center | Phase 1/Phase 2 |
Synonyms for gilteritinib fumarate
| 1254053-84-3 |
| 2-Pyrazinecarboxamide, 6-ethyl-3-((3-methoxy-4-(4-(4-methyl-1-piperazinyl)-1-piperidinyl)phenyl)amino)-5-((tetrahydro-2H-pyran-4-yl)amino)-, (2E)-2-butenedioate (2:1) |
| 2-Pyrazinecarboxamide, 6-ethyl-3-[[3-methoxy-4-[4-(4-methyl-1-piperazinyl)-1-piperidinyl]phenyl]amino]-5-[(tetrahydro-2H-pyran-4-yl)amino]-, (2E)-2-butenedioate (2:1) |
| 5RZZ0Z1GJT |
| ASP-2215 hemifumarate |
| CHEMBL3301603 |
| D10800 |
| Gilteritinib fumarate (JAN/USAN) |
| Gilteritinib fumarate [USAN] |
| Q27262795 |
| UNII-5RZZ0Z1GJT |
| Xospata (TN) |
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 | 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 | ||||
| >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 |
|---|---|---|
| Denmark | 3009428 | Start Trial |
| Cyprus | 1117546 | Start Trial |
| Hungary | E026647 | Start Trial |
| Spain | 2559230 | Start Trial |
| Mexico | 2011011875 | Start Trial |
| Croatia | P20180368 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
