Glasdegib maleate - Generic Drug Details

✉ Email this page to a colleague

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 five 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:	5
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

Generic Entry Date for glasdegib maleate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
National Cancer Institute (NCI)	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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for glasdegib maleate

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Australia	2016251940	Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate	⤷ Sign Up
Cyprus	1118650		⤷ Sign Up
Lithuania	2170860		⤷ Sign Up
Portugal	3286176		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for glasdegib maleate

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2170860	LUC00173	Luxembourg	⤷ Sign Up	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	20C1038	France	⤷ Sign Up	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	122020000057	Germany	⤷ Sign Up	PRODUCT NAME: GLASDEGIB, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, EINSCHLIESSLICH DES MALEATSALZES.; REGISTRATION NO/DATE: EU/1/20/1451 20200626
2170860	2020C/530	Belgium	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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

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 verification 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.