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Last Updated: June 29, 2022

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

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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
Drug patent expirations by year for DAURISMO
Drug Prices for DAURISMO

See drug prices for DAURISMO

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

SponsorPhase
National Cancer Institute (NCI)Phase 1
City of Hope Medical CenterPhase 1
M.D. Anderson Cancer CenterPhase 1/Phase 2

See all DAURISMO clinical trials

Pharmacology 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

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer DAURISMO glasdegib maleate TABLET;ORAL 210656-002 Nov 21, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer DAURISMO glasdegib maleate TABLET;ORAL 210656-001 Nov 21, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Pfizer DAURISMO glasdegib maleate TABLET;ORAL 210656-002 Nov 21, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer DAURISMO glasdegib maleate TABLET;ORAL 210656-002 Nov 21, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Pfizer DAURISMO glasdegib maleate TABLET;ORAL 210656-001 Nov 21, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 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

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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.