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XOSPATA Drug Profile

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Which patents cover Xospata, and what generic alternatives are available?

Xospata is a drug marketed by Astellas and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-seven patent family members in twenty-eight 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 July 1, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XOSPATA

International Patents:	57
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	53
Clinical Trials:	2
Patent Applications:	104
Drug Prices:	Drug price information for XOSPATA
DailyMed Link:	XOSPATA at DailyMed

See drug prices for XOSPATA

Generic Entry Opportunity Date for XOSPATA

NDA:

211349

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 3
Children's Oncology Group	Phase 3
M.D. Anderson Cancer Center	Phase 1/Phase 2

See all XOSPATA clinical trials

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			Y
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes			Y	Y
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes

International Patents for XOSPATA

Country	Patent Number	Estimated Expiration
Russian Federation	2526253
Portugal	2428508
Denmark	2428508
Spain	2667706
European Patent Office	3009428
Hong Kong	1219105
Serbia	54552

Supplementary Protection Certificates for XOSPATA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2428508	8/2020	Austria		PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 (MITTEILUNG) 20191028
2428508	LUC00147	Luxembourg		PRODUCT NAME: GILTERITINIB OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1399 20191028
2428508	PA2020002	Lithuania		PRODUCT NAME: GILTERITINIBAS; REGISTRATION NO/DATE: EU/1/19/1399 20191024
2428508	2020/004	Ireland		PRODUCT NAME: GILTERITINIB OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1399 20191024
2428508	CA 2020 00006	Denmark		PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/19/1399 20191028
2428508	301028	Netherlands		PRODUCT NAME: GILTERITINIB OF EEN ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/19/13177 20191028
2428508	132020000000016	Italy		PRODUCT NAME: GILTERITINIB E SUOI SALI(XOSPATA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1399, 20191028