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Glasdegib maleate - Generic Drug Details

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What are the generic drug 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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Glasdegib maleate has eighty-four patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for glasdegib maleate

International Patents:	84
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	10
Clinical Trials:	1
Patent Applications:	2
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

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

International Patents for glasdegib maleate

Country	Patent Number	Estimated Expiration
South Africa	201706391
South Korea	20170129245
Panama	8785401
New Zealand	735719
Canada	2927736
Lithuania	PA2020528
Peru	20121010

Supplementary Protection Certificates for glasdegib maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2170860	122020000057	Germany		PRODUCT NAME: GLASDEGIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, EINSCHLIESSLICH DES MALEATSALZES.; REGISTRATION NO/DATE: EU/1/20/1451 20200626
2170860	132020000000109	Italy		PRODUCT NAME: GLASDEGIB, OPZIONALMENTE IN FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE, INCLUSO IL SALE MESILATO(DAURISMO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1451, 20200629
2170860	20C1038	France		PRODUCT NAME: GLASDEGIB, OPTIONELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, NOTAMMENT LE SEL DE MALEATE; REGISTRATION NO/DATE: EU/1/20/1451 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	2020C/530	Belgium		PRODUCT NAME: GLASDEGIB, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN, MET INBEGRIP VAN HET MALEAAT ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/20/1451 20200629
2170860	PA2020528	Lithuania		PRODUCT NAME: GLASDEGIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ISKAITANT MALEATO DRUSKA, PAVIDALU; 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