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-three patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for glasdegib maleate

International Patents:	93
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	2
Patent Applications:	7
DailyMed Link:	glasdegib maleate at DailyMed

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

Anatomical Therapeutic Chemical (ATC) Classes for glasdegib maleate

L01XJ	Hedgehog pathway inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No			Y	Y
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes			Y	Y
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes			Y	Y
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes

International Patents for glasdegib maleate

Country	Patent Number	Title	Estimated Expiration
Singapore	11201707863Q	CRYSTALLINE FORMS OF 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDIN-4-YL)-3-(4-CYANOPHENYL)UREA MALEATE
Japan	2010280693	BENZIMIDAZOLE DERIVATIVE
Cyprus	1118650
Canada	2927736	FORMES CRISTALLINES DE 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDINE-4-YL)-3-(4-CYANOPHENYL)UREE MALEATE (CRYSTALLINE FORMS OF 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDIN-4-YL)-3-(4-CYANOPHENYL)UREA MALEATE)
Ukraine	93313	ПОХІДНІ БЕНЗІМІДАЗОЛУ[ПРОИЗВОДНЫЕ БЕНЗИМИДАЗОЛА (BENZIMIDAZOLE DERIVATIVES)

Supplementary Protection Certificates for glasdegib maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2170860	122020000057	Germany		PRODUCT NAME: GLASDEGIB, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, EINSCHLIESSLICH DES MALEATSALZES.; REGISTRATION NO/DATE: EU/1/20/1451 20200626
2170860	LUC00173	Luxembourg		PRODUCT NAME: GLASDEGIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE SEL DE MALEATE; AUTHORISATION NUMBER AND DATE: EU/1/20/1451 20200629
2170860	36/2020	Austria		PRODUCT NAME: GLASDEGIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH DES MALEATSALZES; REGISTRATION NO/DATE: EU/1/20/1451/001 (MITTEILUNG) 20200629
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	2020/034	Ireland		PRODUCT NAME: GLASDEGIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE MALEATE SALT; REGISTRATION NO/DATE: EU/1/20/1451/001 EU/1/20/1451/004 20200626