Get our Free Patent Expiration Newsletter

Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Cantor Fitzgerald
Mallinckrodt
Medtronic
Federal Trade Commission
McKesson

Generated: August 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210656

  Try a free trial


See Plans and Pricing

« Back to Dashboard

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 two 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:2
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:  Try a Free TrialPatent Expiration:Jan 30, 2031Product Flag?YSubstance Flag?YDelist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Harvard Business School
Fish and Richardson
Chinese Patent Office
AstraZeneca
US Department of Justice

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.