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Last Updated: July 15, 2024

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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 five patents protecting this drug.

This drug has ninety-six patent family members in fifty 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

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Summary for DAURISMO
International Patents:96
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 13
Clinical Trials: 2
Patent Applications: 3
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 Loss of Exclusivity (LOE) 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
City of Hope Medical CenterPhase 1
National Cancer Institute (NCI)Phase 1
National Cancer Institute (NCI)Phase 1/Phase 2

See all DAURISMO clinical trials

Pharmacology for DAURISMO

US Patents and Regulatory Information for DAURISMO

DAURISMO is protected by five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DAURISMO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Benzimidazole derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting DAURISMO

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: ⤷  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 ⤷  Sign Up
Pfizer DAURISMO glasdegib maleate TABLET;ORAL 210656-001 Nov 21, 2018 RX Yes No ⤷  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 210656-002 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 ⤷  Sign Up
Pfizer DAURISMO glasdegib maleate TABLET;ORAL 210656-001 Nov 21, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up Y 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 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
Patent: FORMAS CRISTALINAS DE 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-IL)-1-METILPIPERIDIN-4-IL)-3-(4-CIANOFENIL)UREA MALEATO
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 16251940
Patent: Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2017021075
Patent: formas cristalinas de maleato de 1-((2r,4r)-2-(1h-benzo[d]imidazol-2-il)-1-metilpiperidin-4-il)-3-(4-ciano fenil)ureia
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 27736
Patent: FORMES CRISTALLINES DE 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDINE-4-YL)-3-(4-CYANOPHENYL)UREE MALEATE (CRYSTALLINE FORMS OF 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDIN-4-YL)-3-(4-CYANOPHENYL)UREA MALEATE)
Estimated Expiration: ⤷  Sign Up

Patent: 83387
Patent: FORMES CRISTALLINES DU MALEATE DE 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDIN-4-YL)-3-(4-CYANOPHENYL)UREE (CRYSTALLINE FORMS OF 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDIN-4-YL)-3-(4-CYANOPHENYL)UREA MALEATE)
Estimated Expiration: ⤷  Sign Up

China

Patent: 7531667
Patent: 1‑((2R,4R)‑2‑(1H‑苯并[d]咪唑‑2‑基)‑1‑甲基哌啶‑4‑基)‑3‑(4‑氰基苯基)脲马来酸盐的晶形 (CRYSTALLINE FORMS OF 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDIN-4-YL)-3-(4-CYANOPHENYL)UREA MALEATE)
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 24056
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 86176
Estimated Expiration: ⤷  Sign Up

Patent: 66768
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 86176
Patent: DES FORMES CRISTALLINES DE 1-((2R,4R) -2-(1H-BENZO [ D ] IMIDAZOL-2-YL ) -1-MÉTHYLPIPÉRIDIN-4-YL) -3-(4-CYANOPHÉNYL) URÉE MALÉATE (CRYSTALLINE FORMS OF 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDIN-4-YL)-3-(4-CYANOPHENYL)UREA MALEATE)
Estimated Expiration: ⤷  Sign Up

Patent: 66768
Patent: PROCÉDÉ DE PRÉPARATION D'UNE FORME CRISTALLINE DU 1-((2R,4R) -2-(1H-BENZO [ D ] IMIDAZOL-2-YL ) -1-MÉTHYLPIPÉRIDIN-4-YL) -3-(4-CYANOPHÉNYL) URÉE MALÉATE; LE COMPLEXE (1:1) ENTRE MIDAZOLE ET LE 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-MÉTHYLPIPÉRIDIN-4-YL)-3-(4-CYANOPHÉNYL)URÉE MALÉATE (PREPARATION PROCESS OF A CRYSTALLINE FORM OF 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDIN-4-YL)-3-(4-CYANOPHENYL)UREA MALEATE; A CRYSTALLINE FORM OF 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDIN-4-YL)-3-(4-CYANOPHENYL)UREA IMIDAZOLE COMPLEX (1:1))
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 43416
Patent: 1-((2R,4R)-2-(1H-苯並[D]咪唑-2-基)-1-甲基呱啶-4-基)-3-(4-氰基苯基)脲馬來酸鹽的晶形 (CRYSTALLINE FORMS OF 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDIN-4-YL)-3-(4-CYANOPHENYL)UREA MALEATE)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 48664
Estimated Expiration: ⤷  Sign Up

Patent: 59506
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 5224
Patent: Crystalline forms of 1-((2r,4r)-2-(1h-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 45728
Estimated Expiration: ⤷  Sign Up

Patent: 16204373
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 17013645
Patent: FORMAS CRISTALINAS DE 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-IL)-1-ME TILPIPERIDIN-4-IL)-3-(4-CIANOFENIL)UREA MALEATO. (CRYSTALLINE FORMS OF 1-((2R,4R)-2-(1H-BENZO[D]IMIDA ZOL-2-YL)-1-METHYLPIPERIDIN-4-YL)-3-(4-CYANOPHENYL)UREA MALEATE.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 5719
Patent: Crystalline forms of 1-((2r,4r)-2-(1h-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 86176
Estimated Expiration: ⤷  Sign Up

Patent: 66768
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 86176
Estimated Expiration: ⤷  Sign Up

Patent: 66768
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 17564
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 1-((2R,4R)-2-(1H-БЕНЗО[D]ИМИДАЗОЛ-2-ИЛ)-1-МЕТИЛПИПЕРИДИН 4-ИЛ)-3-(4-ЦИАНОФЕНИЛ)МОЧЕВИНЫ МАЛЕАТА (CRYSTALLINE FORMS OF 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDIN-4-YL)-3-(4-CYANOPHENYL)UREA MALEATE)
Estimated Expiration: ⤷  Sign Up

Patent: 17137269
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 1-((2R,4R)-2-(1H-БЕНЗО[D]ИМИДАЗОЛ-2-ИЛ)-1-МЕТИЛПИПЕРИДИН 4-ИЛ)-3-(4-ЦИАНОФЕНИЛ)МОЧЕВИНЫ МАЛЕАТА
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201707863Q
Patent: CRYSTALLINE FORMS OF 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDIN-4-YL)-3-(4-CYANOPHENYL)UREA MALEATE
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 86176
Estimated Expiration: ⤷  Sign Up

Patent: 66768
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1706391
Patent: CRYSTALLINE FORMS OF 1¿((2R,4R)¿2¿(1H¿BENZO[D]IMIDAZOL¿2¿YL)¿1¿METHYLPIPERIDIN¿4¿YL)¿3¿(4¿CYANOPHENYL)UREA MALEATE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2078444
Estimated Expiration: ⤷  Sign Up

Patent: 170129245
Patent: 1-((2R,4R)-2-(1H-벤조[D]이미다졸-2-일)-1-메틸피페리딘-4-일)-3-우레아 말레에이트의 결정질 형태
Estimated Expiration: ⤷  Sign Up

Patent: 190038677
Patent: 1-((2R,4R)-2-(1H-벤조[D]이미다졸-2-일)-1-메틸피페리딘-4-일)-3-우레아 말레에이트의 결정질 형태 (1-2R4R-2-1H-[D]-2--1--4--3-4- CRYSTALLINE FORMS OF 1-2R4R-2-1H-BENZO[D]IMIDAZOL-2-YL-1-METHYLPIPERIDIN-4-YL-3-4-CYANOPHENYLUREA MALEATE)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 74053
Estimated Expiration: ⤷  Sign Up

Patent: 23593
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 46093
Estimated Expiration: ⤷  Sign Up

Patent: 1702238
Patent: Crystalline forms of 1-((2R,4R)-2-(1H-benzo[D]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate
Estimated Expiration: ⤷  Sign Up

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
Guatemala 200900328 DERIVADOS DE BENCIMIDAZOL ⤷  Sign Up
Brazil 112017021075 formas cristalinas de maleato de 1-((2r,4r)-2-(1h-benzo[d]imidazol-2-il)-1-metilpiperidin-4-il)-3-(4-ciano fenil)ureia ⤷  Sign Up
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) ⤷  Sign Up
France 20C1038 ⤷  Sign Up
Eurasian Patent Organization 016888 ПРОИЗВОДНЫЕ БЕНЗИМИДАЗОЛА (BENZIMIDAZOLE DERIVATIVES) ⤷  Sign Up
Singapore 11201707863Q 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 1124056 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DAURISMO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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 CR 2020 00040 Denmark ⤷  Sign Up PRODUCT NAME: GLASDEGIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE MALEATE; REG. NO/DATE: EU/1/20/1451 20200629
2170860 36/2020 Austria ⤷  Sign Up 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 ⤷  Sign Up 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 CA 2020 00040 Denmark ⤷  Sign Up PRODUCT NAME: GLASDEGIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE MALEATE; REG. NO/DATE: EU/1/20/1451 20200629
2170860 301057 Netherlands ⤷  Sign Up 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
>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.