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Details for New Drug Application (NDA): 211349
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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: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Nov 28, 2018 | TE: | 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 Trial | Patent Expiration: | Jul 1, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? |
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