GLASDEGIB MALEATE - Generic Drug Details
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What are the generic sources for glasdegib maleate and what is the scope of patent protection?
Glasdegib maleate
is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Glasdegib maleate has ninety-six patent family members in fifty countries.
One supplier is listed for this compound.
Summary for GLASDEGIB MALEATE
International Patents: | 96 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 13 |
Clinical Trials: | 2 |
Patent Applications: | 5 |
DailyMed Link: | GLASDEGIB MALEATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GLASDEGIB MALEATE
Generic Entry Date for GLASDEGIB MALEATE*:
Constraining patent/regulatory exclusivity:
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 GLASDEGIB MALEATE
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 GLASDEGIB MALEATE
Drug Class | Hedgehog Pathway Inhibitor |
Mechanism of Action | Smoothened Receptor Antagonists |
US Patents and Regulatory Information for GLASDEGIB MALEATE
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 | 210656-002 | Nov 21, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
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 | |||
>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 GLASDEGIB MALEATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | 200911792 | Benzimidazole derivatives | ⤷ Try a Trial |
Canada | 2983387 | 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) | ⤷ Try a Trial |
Slovenia | 3286176 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GLASDEGIB MALEATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2170860 | CR 2020 00040 | Denmark | ⤷ Try a Trial | 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 | ⤷ Try a Trial | 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 | C20200032 00354 | Estonia | ⤷ Try a Trial | PRODUCT NAME: GLASDEGIIB;REG NO/DATE: EU/1/20/1451 29.06.2020 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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