Tavneos generics — when can they launch?
Tavneos (AVACOPAN) · Chemocentryx · 4 active US patents · 0 expired
Where Tavneos sits in the generic timeline
Mid-term cliff: earliest active US patent for Tavneos expires in 2031 (~5 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.
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 — 2 patents
- Method of Use — 1 patent
- Formulation — 1 patent
FDA U-codes carved out by Tavneos 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-3558 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Tavneos drug page →
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This patent protects compounds that are modulators of the C5a receptor, specifically substituted piperidines useful in treating diseases involving C5a receptor activation.USPTO title: C5aR antagonists
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This patent protects compounds that are modulators of the C5a receptor, specifically substituted piperidines useful in treating diseases involving C5a receptor activation.USPTO title: C5aR antagonists
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This patent protects an amorphous form of a complement component 5a receptor, as well as pharmaceutical compositions and methods of treatment using it.USPTO title: Amorphous form of a complement component C5a receptor
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This patent protects solid solution capsule formulations of Compound 1 and methods for making and using them to treat diseases involving C5a receptors.USPTO title: Capsule formulations
Sources
- FDA Orange Book — patents listed against Tavneos (NDA filed 2021)
- Tavneos drug profile — full patent estate, indications, clinical trials, pricing
- Chemocentryx patent portfolio
- Patent cliff 2031 — 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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