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Last Updated: February 26, 2020

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XOSPATA Drug Profile


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When 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

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Summary for XOSPATA
Drug patent expirations by year for XOSPATA
Drug Prices for XOSPATA

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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

SponsorPhase
National Cancer Institute (NCI)Phase 1/Phase 2
M.D. Anderson Cancer CenterPhase 1/Phase 2

See all XOSPATA clinical trials

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.