DAURISMO Drug Patent Profile
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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 eighty-five patent family members in forty-seven 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 will be eligible for patent challenges on November 21, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
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: | 85 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 45 |
Clinical Trials: | 2 |
Patent Applications: | 134 |
Drug Prices: | Drug price information for DAURISMO |
What excipients (inactive ingredients) are in DAURISMO? | DAURISMO excipients list |
DailyMed Link: | DAURISMO at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity Date for DAURISMO
Generic Entry Date for DAURISMO*:
Constraining patent/regulatory exclusivity:
NDA:
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 |
Pharmacology for DAURISMO
Drug Class | Hedgehog Pathway Inhibitor |
Mechanism of Action | Smoothened Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for DAURISMO
US Patents and Regulatory Information for DAURISMO
DAURISMO is protected by four US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of DAURISMO is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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
Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyan- ophenyl)urea maleate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyan- ophenyl)urea maleate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE, IN COMBINATION WITH LOW-DOSE CYTARABINE, FOR THE TREATMENT OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULT PATIENTS WHO ARE >= 75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
Benzimidazole derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Benzimidazole derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting DAURISMO
NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing
INDICATED, IN COMBINATION WITH LOW-DOSE CYTARABINE, FOR THE TREATMENT OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULT PATIENTS WHO ARE >=75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
Exclusivity Expiration: See Plans and Pricing
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
Patent: 4391
Estimated Expiration: See Plans and Pricing
Australia
Patent: 16251940
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2017021075
Estimated Expiration: See Plans and Pricing
Canada
Patent: 27736
Estimated Expiration: See Plans and Pricing
Patent: 83387
Estimated Expiration: See Plans and Pricing
China
Patent: 7531667
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 86176
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 86176
Estimated Expiration: See Plans and Pricing
Patent: 66768
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 43416
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 48664
Estimated Expiration: See Plans and Pricing
Israel
Patent: 5224
Estimated Expiration: See Plans and Pricing
Japan
Patent: 45728
Estimated Expiration: See Plans and Pricing
Patent: 16204373
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 17013645
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 5719
Estimated Expiration: See Plans and Pricing
Poland
Patent: 86176
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 86176
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 17564
Estimated Expiration: See Plans and Pricing
Patent: 17137269
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 201707863Q
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 86176
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 1706391
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 2078444
Estimated Expiration: See Plans and Pricing
Patent: 170129245
Estimated Expiration: See Plans and Pricing
Patent: 190038677
Estimated Expiration: See Plans and Pricing
Spain
Patent: 74053
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 46093
Estimated Expiration: See Plans and Pricing
Patent: 1702238
Estimated Expiration: See Plans and Pricing
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 |
---|---|---|---|
Argentina | 067346 | DERIVADOS DE BENCIMIDAZOL | See Plans and Pricing |
Morocco | 31466 | مشتقات البنزيميدازول. | See Plans and Pricing |
Nicaragua | 200900219 | DERIVADOS DE BENCIMIDAZOL Caso: PC 33611A | See Plans and Pricing |
South Korea | 101143246 | See Plans and Pricing | |
Japan | 6345728 | See Plans and Pricing | |
Taiwan | I646093 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DAURISMO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2170860 | 2020/034 | Ireland | See Plans and Pricing | 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 | 20C1038 | France | See Plans and Pricing | 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 | LUC00173 | Luxembourg | See Plans and Pricing | 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 | 122020000057 | Germany | See Plans and Pricing | 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 | See Plans and Pricing | 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 | 2090036-1 | Sweden | See Plans and Pricing | PRODUCT NAME: GLASDEGIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE MALEATE SALT; REG. NO/DATE: EU/1/20/1451 20200629 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |