GLASDEGIB MALEATE - Generic Drug Details

What are the generic sources for glasdegib maleate and what is the scope of patent protection?

Glasdegib maleate is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Glasdegib maleate has ninety-six patent family members in fifty countries.

One supplier is listed for this compound.

Summary for GLASDEGIB MALEATE

International Patents:	96
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	2
Patent Applications:	5
DailyMed Link:	GLASDEGIB MALEATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GLASDEGIB MALEATE

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.

Recent Clinical Trials for GLASDEGIB MALEATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
City of Hope Medical Center	Phase 1
National Cancer Institute (NCI)	Phase 1
M.D. Anderson Cancer Center	Phase 1/Phase 2

See all GLASDEGIB MALEATE clinical trials

Pharmacology for GLASDEGIB MALEATE

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

US Patents and Regulatory Information for GLASDEGIB MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes			Y	Y
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes			Y

International Patents for GLASDEGIB MALEATE

Country	Patent Number	Title	Estimated Expiration
Taiwan	200911792	Benzimidazole derivatives
Canada	2983387	FORMES CRISTALLINES DU MALEATE DE 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDIN-4-YL)-3-(4-CYANOPHENYL)UREE (CRYSTALLINE FORMS OF 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDIN-4-YL)-3-(4-CYANOPHENYL)UREA MALEATE)
Slovenia	3286176

Supplementary Protection Certificates for GLASDEGIB MALEATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2170860	CR 2020 00040	Denmark		PRODUCT NAME: GLASDEGIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE MALEATE; REG. NO/DATE: EU/1/20/1451 20200629
2170860	301057	Netherlands		PRODUCT NAME: GLASDEGIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, MET INBEGRIP VAN HET MALEAATZOUT; REGISTRATION NO/DATE: EU/1/20/1451/001-004 20200626
2170860	C20200032 00354	Estonia		PRODUCT NAME: GLASDEGIIB;REG NO/DATE: EU/1/20/1451 29.06.2020