Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 7, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210656

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NDA 210656 describes DAURISMO, which is a drug marketed by Pfizer Inc 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 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.
Summary for 210656
Tradename:DAURISMO
Applicant:Pfizer Inc
Ingredient:glasdegib maleate
Patents:3
Generic Entry Opportunity 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
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:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Nov 21, 2018TE: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
Regulatory Exclusivity Expiration:Nov 21, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Apr 13, 2036Product Flag?YSubstance Flag?YDelist Request?

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