CEDAZURIDINE generics — when can they launch?
CEDAZURIDINE (CEDAZURIDINE) · · 6 active US patents · 0 expired
Where CEDAZURIDINE sits in the generic timeline
Imminent generic cliff: earliest active US patent for CEDAZURIDINE 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.
- Method of Use — 3 patents
- Formulation — 2 patents
- Composition of Matter — 1 patent
FDA U-codes carved out by CEDAZURIDINE 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-2864 | (no description) |
U-2866 | (no description) |
U-2865 | (no description) |
Sample patent estate
Showing 6 of 6 active US patents. View full estate on the CEDAZURIDINE drug page →
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This patent protects certain tetrahydrouridine derivative compounds, compositions, and kits, and methods of making and using these compounds.USPTO title: Certain compounds, compositions and methods
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This patent protects certain tetrahydrouridine derivative compounds and methods of making and using them.USPTO title: Certain compounds, compositions and methods
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This patent protects certain tetrahydrouridine derivative compounds, pharmaceutical compositions, and kits, as well as methods of making and using these compounds.USPTO title: Certain compounds, compositions and methods
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This patent protects methods for synthesizing 2â²-deoxy-2â²,2â²-difluorotetrahydrouridine with increased purity and uniform particle size distribution.USPTO title: 2â²-deoxy-2â²,2â²-difluorotetrahydrouridines with high purity and methods of making the same
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This patent protects solid oral dosage forms of a combination of decitabine and cedazuridine.USPTO title: Combination decitabine and cedazuridine solid oral dosage forms
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This patent protects a method of using cedazuridine in combination with decitabine in solid oral dosage forms.USPTO title: Combination decitabine and cedazuridine solid oral dosage forms
Sources
- FDA Orange Book — patents listed against CEDAZURIDINE (NDA filed 2020)
- CEDAZURIDINE drug profile — full patent estate, indications, clinical trials, pricing
- 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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