Glasdegib maleate - Generic Drug Details

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 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
National Cancer Institute (NCI)	Phase 1
City of Hope Medical Center	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	210656-001	Nov 21, 2018		RX	Yes	No			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			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
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes			Y	Y

International Patents for glasdegib maleate

Country	Patent Number	Title	Estimated Expiration
Spain	2774053
Japan	2016204373	１−（（２Ｒ，４Ｒ）−２−（１Ｈ−ベンゾ［Ｄ］イミダゾール−２−イル）−１−メチルピペリジン−４−イル）−３−（４−シアノフェニル）尿素マレイン酸塩の結晶性形態 (CRYSTALLINE FORM OF 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOLE-2-YL)-1-METHYLPIPERIDINE-4-YL)-3-(4-CYANOPHENYL)UREA MALEATE)
Norway	2020027
Brazil	PI0813412	DERIVADOS DE BENZIMIDAZOL
Morocco	31466	مشتقات البنزيميدازول.
Israel	202420	תולדות בנזימידאזול (Benzimidazole derivatives)

Supplementary Protection Certificates for glasdegib maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2170860	2020027	Norway		PRODUCT NAME: GLASDEGIB, EVENTUELT I FORM AV ET FARMASOEYTISK AKSEPTABELT SALT, INKLUDERT MALEATSALTET; REG. NO/DATE: EU/1/20/1451 20200703
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	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	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
2170860	PA2020528	Lithuania		PRODUCT NAME: GLASDEGIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ISKAITANT MALEATO DRUSKA, PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1451 20200626
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