DAURISMO Drug Patent Profile

Which patents cover Daurismo, and when can generic versions of Daurismo launch?

Daurismo is a drug marketed by Pfizer and is included in one NDA. There are four patents protecting this drug.

This drug has ninety-three patent family members in forty-nine countries.

The generic ingredient in DAURISMO is glasdegib maleate. One supplier is listed for this compound. Additional details are available on the glasdegib maleate profile page.

DrugPatentWatch^® Generic Entry Outlook for Daurismo

Daurismo was eligible for patent challenges on November 21, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 13, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DAURISMO

International Patents:	93
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	2
Patent Applications:	197
Drug Prices:	Drug price information for DAURISMO
What excipients (inactive ingredients) are in DAURISMO?	DAURISMO excipients list
DailyMed Link:	DAURISMO at DailyMed

See drug prices for DAURISMO

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

NDA:

210656

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 DAURISMO

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 DAURISMO clinical trials

Pharmacology for DAURISMO

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for DAURISMO

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

US Patents and Regulatory Information for DAURISMO

DAURISMO is protected by four US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting DAURISMO

FDA Regulatory Exclusivity protecting DAURISMO

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
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
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	210656-001	Nov 21, 2018		RX	Yes	No			Y

International Patents for DAURISMO

When does loss-of-exclusivity occur for DAURISMO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DAURISMO around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	2170860
African Regional IP Organization (ARIPO)	2377	Benzimidazole derivatives.
Canada	2690953	DERIVES DE BENZAMIDAZOLE (BENZIMIDAZOLE DERIVATIVES)
Australia	2008272641	Benzimidazole derivatives
Slovenia	3666768
Tunisia	2009000544	DERIVES DE BENZIMIDAZOLE
Portugal	2170860

Supplementary Protection Certificates for DAURISMO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	SPC/GB20/044	United Kingdom		PRODUCT NAME: GLASDEGIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING MALEATE SALT; REGISTERED: UK EU/1/20/1451(FOR NI) 20200629; UK PLGB 00057-1687 20200629; UK PLGB 00057-1688 20200629
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	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	122020000057	Germany		PRODUCT NAME: GLASDEGIB, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, EINSCHLIESSLICH DES MALEATSALZES.; REGISTRATION NO/DATE: EU/1/20/1451 20200626
2170860	C20200032 00354	Estonia		PRODUCT NAME: GLASDEGIIB;REG NO/DATE: EU/1/20/1451 29.06.2020