➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Baxter
Merck
Mallinckrodt
Moodys

Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211349


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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 two 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:2
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:Jan 27, 2031Product Flag?YSubstance Flag?YDelist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
AstraZeneca
Merck
McKinsey
Medtronic

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 verification 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.