Details for New Drug Application (NDA): 210656
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NDA 210656 describes DAURISMO, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the DAURISMO profile page.
The generic ingredient in DAURISMO is glasdegib maleate. One supplier is listed for this compound. Additional details are available on the glasdegib maleate profile page.
The generic ingredient in DAURISMO is glasdegib maleate. One supplier is listed for this compound. Additional details are available on the glasdegib maleate profile page.
Summary for 210656
| Tradename: | DAURISMO |
| Applicant: | Pfizer |
| Ingredient: | glasdegib maleate |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210656
Generic Entry Date for 210656*:
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.
Pharmacology for NDA: 210656
| Mechanism of Action | Smoothened Receptor Antagonists |
Suppliers and Packaging for NDA: 210656
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAURISMO | glasdegib maleate | TABLET;ORAL | 210656 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0298 | 0069-0298-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0069-0298-60) |
| DAURISMO | glasdegib maleate | TABLET;ORAL | 210656 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-1531 | 0069-1531-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-1531-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Nov 21, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 21, 2025 | ||||||||
| Regulatory Exclusivity Use: | INDICATED, IN COMBINATION WITH LOW-DOSE CYTARABINE, FOR THE TREATMENT OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULT PATIENTS WHO ARE >=75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY | ||||||||
| Patent: | 10,414,748 | Patent Expiration: | Apr 13, 2036 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 11,168,066 | Patent Expiration: | Apr 13, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE, IN COMBINATION WITH LOW-DOSE CYTARABINE, FOR THE TREATMENT OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULT PATIENTS WHO ARE >= 75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY | ||||||||
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