DAURISMO Drug Patent Profile
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Which patents cover Daurismo, and what generic alternatives are available?
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DAURISMO
*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 |
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 | ||||
| >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 |
|---|---|---|---|
| South Africa | 200908626 | Benzimidazole Derivatives | ⤷ Sign Up |
| Hungary | E048664 | ⤷ Sign Up | |
| Peru | 20121010 | DERIVADOS DE BENCIMIDAZOL | ⤷ Sign Up |
| Spain | 2609258 | ⤷ Sign Up | |
| Japan | 4567099 | ⤷ Sign Up | |
| Israel | 202420 | תולדות בנזימידאזול (Benzimidazole derivatives) | ⤷ 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 | 2090036-1 | Sweden | ⤷ Sign Up | PRODUCT NAME: GLASDEGIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE MALEATE SALT; REG. NO/DATE: EU/1/20/1451 20200629 |
| 2170860 | PA2020528 | Lithuania | ⤷ Sign Up | PRODUCT NAME: GLASDEGIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ISKAITANT MALEATO DRUSKA, PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1451 20200626 |
| 2170860 | 2020027 | Norway | ⤷ Sign Up | PRODUCT NAME: GLASDEGIB, EVENTUELT I FORM AV ET FARMASOEYTISK AKSEPTABELT SALT, INKLUDERT MALEATSALTET; REG. NO/DATE: EU/1/20/1451 20200703 |
| 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 | 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 | 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 |
| >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.
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