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Last Updated: February 3, 2023

Glasdegib maleate - Generic Drug Details


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What are the generic drug 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-three patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for glasdegib maleate
International Patents:93
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 12
Clinical Trials: 2
Patent Applications: 7
DailyMed Link:glasdegib maleate at DailyMed
Recent Clinical Trials for glasdegib maleate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Cancer Institute (NCI)Phase 1
City of Hope Medical CenterPhase 1
M.D. Anderson Cancer CenterPhase 1/Phase 2

See all glasdegib maleate clinical trials

Pharmacology for glasdegib maleate

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 210656-001 Nov 21, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pfizer DAURISMO glasdegib maleate TABLET;ORAL 210656-001 Nov 21, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer DAURISMO glasdegib maleate TABLET;ORAL 210656-001 Nov 21, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Pfizer DAURISMO glasdegib maleate TABLET;ORAL 210656-002 Nov 21, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Pfizer DAURISMO glasdegib maleate TABLET;ORAL 210656-002 Nov 21, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer DAURISMO glasdegib maleate TABLET;ORAL 210656-002 Nov 21, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
Spain 2774053 See Plans and Pricing
Japan 2016204373 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) See Plans and Pricing
Norway 2020027 See Plans and Pricing
Brazil PI0813412 DERIVADOS DE BENZIMIDAZOL See Plans and Pricing
Morocco 31466 مشتقات البنزيميدازول. See Plans and Pricing
Israel 202420 תולדות בנזימידאזול (Benzimidazole derivatives) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for glasdegib maleate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2170860 2020027 Norway See Plans and Pricing PRODUCT NAME: GLASDEGIB, EVENTUELT I FORM AV ET FARMASOEYTISK AKSEPTABELT SALT, INKLUDERT MALEATSALTET; REG. NO/DATE: EU/1/20/1451 20200703
2170860 132020000000109 Italy See Plans and Pricing 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 See Plans and Pricing 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 2020/034 Ireland See Plans and Pricing 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 PA2020528 Lithuania See Plans and Pricing PRODUCT NAME: GLASDEGIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ISKAITANT MALEATO DRUSKA, PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1451 20200626
2170860 36/2020 Austria See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Merck
Mallinckrodt
McKinsey
Baxter

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