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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.
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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