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XOSPATA Drug Profile
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See Plans and PricingWhen do Xospata patents expire, and when can generic versions of Xospata launch?
Xospata is a drug marketed by Astellas and is included in one NDA. There are two patents protecting this drug.
This drug has forty patent family members in twenty-six countries.
The generic ingredient in XOSPATA is gilteritinib fumarate. One supplier is listed for this compound. Additional details are available on the gilteritinib fumarate profile page.
US ANDA Litigation and Generic Entry Outlook for Xospata
Xospata will be eligible for patent challenges on November 28, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 27, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for XOSPATA
| International Patents: | 40 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 44 |
| Clinical Trials: | 1 |
| Patent Applications: | 8 |
| Drug Prices: | Drug price information for XOSPATA |
| DailyMed Link: | XOSPATA at DailyMed |
Generic Entry Opportunity Date for XOSPATA
Generic Entry Date for XOSPATA*:
Constraining patent/regulatory exclusivity:
NDA:
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 XOSPATA
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 XOSPATA
| 1254053-43-4 |
| 2-Pyrazinecarboxamide, 6-ethyl-3-((3-methoxy-4-(4-(4-methyl-1-piperazinyl)-1-piperidinyl)phenyl)amino)-5-((tetrahydro-2H-pyran-4-yl)amino)- |
| 2-Pyrazinecarboxamide, 6-ethyl-3-[[3-methoxy-4-[4-(4-methyl-1-piperazinyl)-1-piperidinyl]phenyl]amino]-5-[(tetrahydro-2H-pyran-4-yl)amino]- |
| 3694AH |
| 6-ethyl-3-((3-methoxy-4-(4-(4-methyl-1-piperazinyl)-1-piperidinyl)phenyl)amino)-5-((tetrahydro-2H-pyran-4-yl)amino)-2-pyrazinecarboxamide |
| 6-Ethyl-3-((3-methoxy-4-(4-(4-methylpiperazin-1-yl)piperidin-1-yl)phenyl)-amino)-5-((tetrahydro-2H-pyran-4-yl)amino)pyrazine-2-carboxamide |
| 6-Ethyl-3-((3-methoxy-4-(4-(4-methylpiperazin-1-yl)piperidin-1-yl)phenyl)amino)-5-((tetrahydro-2H-pyran-4-yl)amino)pyrazine-2-carboxamide |
| 6-ethyl-3-({3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}amino)-5-(tetrahydro-2H-pyran-4-ylamino)pyrazine-2-carboxamide |
| 6-ethyl-3-[[3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl]amino]-5-(oxan-4-ylamino)pyrazine-2-carboxamide |
| 6-ethyl-3-[3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]anilino]-5-(oxan-4-ylamino)pyrazine-2-carboxamide |
| 6-Ethyl-3-[3-methoxy-4-[4-(4-methylpiperazine-1-yl)piperidino]anilino]-5-[(tetrahydro-2H-pyran-4-yl)amino]pyrazine-2-carboxamide |
| 6-ethyl-3-{3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]anilino}-5-(tetrahydro-2H-pyran-4-ylamino)pyrazine-2-carboxamide |
| 6-ethyl-3-{3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]anilino}-5-[(oxan-4-yl)amino]pyrazine-2-carboxamide |
| 66D92MGC8M |
| A14411 |
| AC-29030 |
| AS-35199 |
| ASP 2215 |
| ASP-2215 |
| ASP2215 |
| BCP28756 |
| BDBM144315 |
| C29H44N8O3 |
| C6F |
| CHEBI:145372 |
| CHEMBL3301622 |
| CS-3885 |
| D10709 |
| DB-108103 |
| DB12141 |
| EX-A2775 |
| Gilteritinib |
| Gilteritinib (ASP-2215) |
| Gilteritinib (ASP2215) |
| Gilteritinib (USAN/INN) |
| Gilteritinib [USAN:INN] |
| gilteritinib-asp2215 |
| Gilteritinib(ASP2215) |
| gilteritinibum |
| GTPL8708 |
| HY-12432 |
| KS-0000064E |
| MFCD28144685 |
| NCGC00481652-01 |
| NCGC00481652-02 |
| Q27077802 |
| QC-11768 |
| s7754 |
| SB16988 |
| SCHEMBL282229 |
| UNII-66D92MGC8M |
| US8969336, 547 |
| US8969336, 577 |
| ZINC000113476229 |
| ZINC113476229 |
US Patents and Regulatory Information for XOSPATA
| 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 XOSPATA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Serbia | 57045 | Start Trial |
| Slovenia | 3009428 | Start Trial |
| Canada | 2760061 | Start Trial |
| Israel | 216132 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
