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 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
Summary for DAURISMO
| International Patents: | 96 |
| US Patents: | 4 |
| 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
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 |
|---|---|
| City of Hope Medical Center | Phase 1 |
| National Cancer Institute (NCI) | 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 one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of DAURISMO is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Benzimidazole derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pfizer | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656-002 | Nov 21, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Pfizer | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656-001 | Nov 21, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Pfizer | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656-002 | Nov 21, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >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: ⤷ Try a Trial
Australia
Patent: 16251940
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2017021075
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 27736
Estimated Expiration: ⤷ Try a Trial
Patent: 83387
Estimated Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Cyprus
Patent: 24056
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 86176
Estimated Expiration: ⤷ Try a Trial
Patent: 66768
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 86176
Estimated Expiration: ⤷ Try a Trial
Patent: 66768
Estimated Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Hungary
Patent: 48664
Estimated Expiration: ⤷ Try a Trial
Patent: 59506
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 5224
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 45728
Estimated Expiration: ⤷ Try a Trial
Patent: 16204373
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 17013645
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 5719
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 86176
Estimated Expiration: ⤷ Try a Trial
Patent: 66768
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 86176
Estimated Expiration: ⤷ Try a Trial
Patent: 66768
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 17564
Estimated Expiration: ⤷ Try a Trial
Patent: 17137269
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201707863Q
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 86176
Estimated Expiration: ⤷ Try a Trial
Patent: 66768
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1706391
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2078444
Estimated Expiration: ⤷ Try a Trial
Patent: 170129245
Patent: 1-((2R,4R)-2-(1H-벤조[D]이미다졸-2-일)-1-메틸피페리딘-4-일)-3-우레아 말레에이트의 결정질 형태
Estimated Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Spain
Patent: 74053
Estimated Expiration: ⤷ Try a Trial
Patent: 23593
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 46093
Estimated Expiration: ⤷ Try a Trial
Patent: 1702238
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Hungary | E059506 | ⤷ Try a Trial | |
| Spain | 2774053 | ⤷ Try a Trial | |
| Denmark | 3666768 | ⤷ Try a Trial | |
| Cuba | 23847 | 2-PIPERIDINILO BENCIMIDAZOLES ÚTILES EN EL TRATAMIENTO DEL CRECIMIENTO CELULAR ANORMAL | ⤷ Try a Trial |
| >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 | ⤷ Try a Trial | 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 | 2020C/530 | Belgium | ⤷ Try a Trial | 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 | PA2020528 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: GLASDEGIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ISKAITANT MALEATO DRUSKA, PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1451 20200626 |
| 2170860 | 36/2020 | Austria | ⤷ Try a Trial | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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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