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DAURISMO Drug Profile
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Which patents cover Daurismo, and what generic alternatives are available?
Daurismo is a drug marketed by Pfizer Inc and is included in one NDA. There are three patents protecting this drug.
This drug has sixty-eight patent family members in forty-five 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.
US ANDA Litigation and Generic Entry Outlook for Daurismo
Daurismo will be eligible for patent challenges on November 21st, 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 13th, 2036. This may change due to patent challenges or generic licensing.
Summary for DAURISMO
| International Patents: | 68 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 39 |
| Patent Applications: | 5 |
| Drug Prices: | Drug price information for DAURISMO |
| DailyMed Link: | DAURISMO at DailyMed |
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.
Pharmacology for DAURISMO
| Drug Class | Hedgehog Pathway Inhibitor |
| Mechanism of Action | Smoothened Receptor Antagonists |
Synonyms for DAURISMO
| 1-((2R,4R)-2-(1H-Benzimidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate salt |
| 1-((2R,4R)-2-(1H-Benzimidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)ureamaleatesalt |
| 1-((2R,4R)-2-(1H-benzo[d]iMidazol-2-yl)-1-Methylpiperidin-4-yl)-3-(4-cyanophenyl)urea |
| 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea(PF-04449913) |
| 1-[(2R,4R)-2-(1H-benzimidazol-2-yl)-1-methylpiperidin-4-yl]-3-(4-cyanophenyl)urea |
| 1095173-27-5 |
| 2030410-25-2 |
| 2640AH |
| 4-[(2R)-2-[(1R)-2,2,2-Trifluoro-1-hydroxyethyl]-1-pyrrolidinyl]-2-(trifluoromethyl)-benzonitrile |
| BC600416 |
| BDBM50385635 |
| C21H22N6O |
| CHEBI:145428 |
| CHEMBL2043437 |
| CS-2731 |
| D10636 |
| D11107 |
| Daurismo (TN) |
| DB11978 |
| EX-A858 |
| Glasdegib |
| Glasdegib (PF-04449913) |
| Glasdegib (USAN/INN) |
| Glasdegib [USAN:INN] |
| Glasdegib maleate |
| Glasdegib maleate (JAN) |
| glasdegib-pf-04449913 |
| Glasdegib(PF-04449913) |
| glasdegibum |
| GTPL8201 |
| HY-16391 |
| J-690029 |
| K673DMO5H9 |
| LQT-B00722 |
| MFCD25976839 |
| N-[(2R,4R)-2-(1H-Benzimidazol-2-yl)-1-methyl-4-piperidinyl]-N'-(4-cyanophenyl)urea |
| N-[(2R,4R)-2-(1H-benzimidazol-2-yl)-1-methylpiperidin-4-yl]-N'-(4-cyanophenyl)urea |
| NCGC00378600-02 |
| PF 04449913 |
| PF-04449913 |
| PF-04449913 maleate |
| PF-04449913 maleate salt, >=98% (HPLC) |
| PF-04449913;Glasdegib |
| PF-4449913 |
| PF-913 |
| Q27077810 |
| QC-11459 |
| SB16679 |
| SCHEMBL18171548 |
| SCHEMBL2068480 |
| SFNSLLSYNZWZQG-VQIMIIECSA-N |
| TH2EV99S4Z |
| UNII-K673DMO5H9 |
| UNII-TH2EV99S4Z |
| Urea, N-((2R,4R)-2-(1H-benzimidazol-2-yl)-1-methyl-4-piperidinyl)-N'-(4-cyanophenyl)-, (2Z)-2-butenedioate (1:1) |
| Urea, N-[(2R,4R)-2-(1H-benzimidazol-2-yl)-1-methyl-4-piperidinyl]-N'-(4-cyanophenyl)- |
| Z-3230 |
| ZINC68251434 |
US Patents and Regulatory Information for DAURISMO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer Inc | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656-001 | Nov 21, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Pfizer Inc | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656-002 | Nov 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Pfizer Inc | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656-001 | Nov 21, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pfizer Inc | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656-002 | Nov 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Pfizer Inc | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656-001 | Nov 21, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Pfizer Inc | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656-001 | Nov 21, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovenia | 2170860 | Start Trial |
| Costa Rica | 11150 | Start Trial |
| Brazil | PI0813412 | Start Trial |
| Taiwan | 200911792 | Start Trial |
| Serbia | 55395 | Start Trial |
| Ecuador | SP099803 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
