Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 6, 2019

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Glasdegib maleate - Generic Drug Details

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What are the generic sources for glasdegib maleate and what is the scope of freedom to operate?

Glasdegib maleate is the generic ingredient in one branded drug marketed by Pfizer Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Glasdegib maleate has sixty-seven patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for glasdegib maleate
International Patents:67
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 5
Patent Applications: 2
DailyMed Link:glasdegib maleate at DailyMed
Pharmacology for glasdegib maleate
Synonyms for glasdegib maleate
1-((2R,4R)-2-(1H-Benzimidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate salt
2030410-25-2
D11107
Daurismo
Glasdegib maleate (JAN)
PF 04449913 maleate
PF-04449913 maleate
PF-04449913 maleate salt, >=98% (HPLC)
SCHEMBL18171548
TH2EV99S4Z
UNII-TH2EV99S4Z
Urea, N-((2R,4R)-2-(1H-benzimidazol-2-yl)-1-methyl-4-piperidinyl)-N'-(4-cyanophenyl)-, (2Z)-2-butenedioate (1:1)

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 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 210656-001 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 Y Y   Start Trial
Pfizer Inc DAURISMO glasdegib maleate TABLET;ORAL 210656-002 Nov 21, 2018 RX Yes Yes   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   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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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Merck

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