Daurismo generics — when can they launch?
Daurismo (Glasdegib Maleate) · Pfizer · 10 active US patents · 0 expired
Where Daurismo sits in the generic timeline
Imminent generic cliff: earliest active US patent for Daurismo expires in 2028 (~2 years from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Composition of Matter — 4 patents
- Method of Use — 4 patents
- Formulation — 2 patents
FDA U-codes carved out by Daurismo patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-3254 | (no description) |
Sample patent estate
Showing 6 of 10 active US patents. View full estate on the Daurismo drug page →
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This patent protects novel benzimidazole derivatives and their use in treating abnormal cell growth, such as cancer, in mammals.USPTO title: Benzimidazole derivatives
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This patent protects novel benzimidazole derivatives and their use in treating abnormal cell growth, such as cancer, in mammals.USPTO title: Benzimidazole derivatives
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This patent protects novel benzimidazole derivatives, useful in treating abnormal cell growth such as cancer in mammals.USPTO title: Benzimidazole derivatives
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This patent protects novel benzimidazole derivatives, useful in treating abnormal cell growth such as cancer in mammals.USPTO title: Benzimidazole derivatives
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This patent protects crystalline forms of the molecule 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate.USPTO title: Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate
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This patent protects crystalline forms of a compound used in pharmaceutical compositions, specifically for treating abnormal cell growth in mammals.USPTO title: Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate
Sources
- FDA Orange Book — patents listed against Daurismo (NDA filed 2018)
- Daurismo drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer patent portfolio
- Patent cliff 2028 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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