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Last Updated: March 9, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211349

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NDA 211349 describes XOSPATA, which is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the XOSPATA profile page.

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.
Summary for 211349
Tradename:XOSPATA
Applicant:Astellas
Ingredient:gilteritinib fumarate
Patents:3
Generic Entry Opportunity Date for 211349
Generic Entry Date for 211349*:
Constraining patent/regulatory exclusivity:
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.

Suppliers and Packaging for NDA: 211349
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XOSPATA gilteritinib fumarate TABLET;ORAL 211349 NDA Astellas Pharma US, Inc. 0469-1425 0469-1425-90 1 BOTTLE in 1 CARTON (0469-1425-90) > 90 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Nov 28, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 28, 2025
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF ADULT PATIENTS WHO HAVE RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A FMS-LIKE TYROSINE KINASE 3 (FLT3) MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Regulatory Exclusivity Expiration:Nov 28, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Jul 1, 2036Product Flag?YSubstance Flag?Delist Request?

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