VADADUSTAT generics — when can they launch?
VADADUSTAT (VADADUSTAT) · · 42 active US patents · 0 expired
Where VADADUSTAT sits in the generic timeline
Imminent generic cliff: earliest active US patent for VADADUSTAT expires in 2027 (~1 year 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 — 21 patents
- Composition of Matter — 18 patents
- Formulation — 3 patents
FDA U-codes carved out by VADADUSTAT 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-3876 | (no description) |
Sample patent estate
Showing 6 of 42 active US patents. View full estate on the VADADUSTAT drug page →
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This patent protects the composition of matter of vadadustat, an active drug substance.
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This patent protects the composition of matter of vadadustat, an active drug substance.
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This patent protects a prolyl hydroxylase inhibitor, specifically a compound called VADADUSTAT, and methods for using it to treat various diseases.USPTO title: Prolyl hydroxylase inhibitors and methods of use
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This patent protects methods of using prolyl hydroxylase inhibitors, such as vandetabine (vadadustat), to treat conditions including Peripheral Vascular Disease and heart failure.USPTO title: Prolyl hydroxylase inhibitors and methods of use
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This patent protects methods of using prolyl hydroxylase inhibitors, such as vandetabine (vadadustat), to treat conditions including Peripheral Vascular Disease and heart failure.USPTO title: Prolyl hydroxylase inhibitors and methods of use
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This patent protects a prolyl hydroxylase inhibitor, specifically a compound called VADADUSTAT, and its methods of use for treating various diseases.USPTO title: Prolyl hydroxylase inhibitors and methods of use
Sources
- FDA Orange Book — patents listed against VADADUSTAT (NDA filed 2023)
- VADADUSTAT drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2027 — 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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