By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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DAURISMO Drug 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 three patents protecting this drug.
This drug has eighty-two 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
Summary for DAURISMO
| International Patents: | 82 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 39 |
| Clinical Trials: | 1 |
| Patent Applications: | 67 |
| Drug Prices: | Drug price information for DAURISMO |
| What excipients (inactive ingredients) are in DAURISMO? | DAURISMO excipients list |
| DailyMed Link: | DAURISMO at DailyMed |
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
| Sponsor | Phase |
|---|---|
| City of Hope Medical Center | Phase 1 |
| National Cancer Institute (NCI) | Phase 1 |
Pharmacology for DAURISMO
| Drug Class | Hedgehog Pathway Inhibitor |
| Mechanism of Action | Smoothened Receptor Antagonists |
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 | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656-001 | Nov 21, 2018 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Pfizer | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656-002 | Nov 21, 2018 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Pfizer | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656-001 | Nov 21, 2018 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Pfizer | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656-002 | Nov 21, 2018 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Pfizer | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656-001 | Nov 21, 2018 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Pfizer | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656-001 | Nov 21, 2018 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| >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 |
|---|---|---|
| Mexico | 2017013645 | Try Before You Buy |
| European Patent Office | 3286176 | Try Before You Buy |
| World Intellectual Property Organization (WIPO) | 2009004427 | Try Before You Buy |
| Israel | 255224 | Try Before You Buy |
| Honduras | 2008000974 | Try Before You Buy |
| Lithuania | PA2020528 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DAURISMO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2170860 | CR 2020 00040 | Denmark | Try Before You Buy | PRODUCT NAME: GLASDEGIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE MALEATE; REG. NO/DATE: EU/1/20/1451 20200629 |
| 2170860 | 132020000000109 | Italy | Try Before You Buy | 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 | 301057 | Netherlands | Try Before You Buy | 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 |
| 2170860 | CA 2020 00040 | Denmark | Try Before You Buy | PRODUCT NAME: GLASDEGIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE MALEATE; REG. NO/DATE: EU/1/20/1451 20200629 |
| 2170860 | 122020000057 | Germany | Try Before You Buy | PRODUCT NAME: GLASDEGIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, EINSCHLIESSLICH DES MALEATSALZES.; REGISTRATION NO/DATE: EU/1/20/1451 20200626 |
| 2170860 | 2020C/530 | Belgium | Try Before You Buy | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
