Details for New Drug Application (NDA): 216993
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NDA 216993 describes VANFLYTA, which is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the VANFLYTA profile page.
The generic ingredient in VANFLYTA is quizartinib dihydrochloride. One supplier is listed for this compound. Additional details are available on the quizartinib dihydrochloride profile page.
The generic ingredient in VANFLYTA is quizartinib dihydrochloride. One supplier is listed for this compound. Additional details are available on the quizartinib dihydrochloride profile page.
Summary for 216993
| Tradename: | VANFLYTA |
| Applicant: | Daiichi Sankyo Inc |
| Ingredient: | quizartinib dihydrochloride |
| Patents: | 11 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216993
Generic Entry Date for 216993*:
Constraining patent/regulatory exclusivity:
FOR USE IN COMBINATION WITH STANDARD INDUCTION AND CONSOLIDATION, AND AS MAINTENANCE THERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR THE TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) THAT IS FLT3 INTERNAL TANDEM DUPLICATION (ITD)-POSITIVE AS DETECTED BY AN FDA-APPROVED TEST 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.
Pharmacology for NDA: 216993
| Mechanism of Action | FMS-like Receptor Tyrosine Kinase 3 (FLT3) Inhibitors |
Suppliers and Packaging for NDA: 216993
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VANFLYTA | quizartinib dihydrochloride | TABLET;ORAL | 216993 | NDA | Daiichi Sankyo Inc. | 65597-504 | 65597-504-04 | 1 BOTTLE in 1 CARTON (65597-504-04) / 14 TABLET, FILM COATED in 1 BOTTLE |
| VANFLYTA | quizartinib dihydrochloride | TABLET;ORAL | 216993 | NDA | Daiichi Sankyo Inc. | 65597-504 | 65597-504-28 | 1 BOTTLE in 1 CARTON (65597-504-28) / 28 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 17.7MG BASE | ||||
| Approval Date: | Jul 20, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 20, 2030 | ||||||||
| Regulatory Exclusivity Use: | FOR USE IN COMBINATION WITH STANDARD INDUCTION AND CONSOLIDATION, AND AS MAINTENANCE THERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR THE TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) THAT IS FLT3 INTERNAL TANDEM DUPLICATION (ITD)-POSITIVE AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
| Regulatory Exclusivity Expiration: | Jul 20, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 7,820,657 | Patent Expiration: | Sep 26, 2028 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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