Afinitor generics — when can they launch?
Afinitor (everolimus) · Novartis · 4 active US patents · 8 expired
Where Afinitor sits in the generic timeline
Imminent generic cliff: earliest active US patent for Afinitor 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 — 4 patents
FDA U-codes carved out by Afinitor 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-1681 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Afinitor drug page →
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USPTO title: Neuroendocrine tumor treatment
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USPTO title: Neuroendocrine tumor treatment
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USPTO title: Neuroendocrine tumor treatment
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USPTO title: Neuroendocrine tumor treatment
Sources
- FDA Orange Book — patents listed against Afinitor (NDA filed 2009)
- Afinitor drug profile — full patent estate, indications, clinical trials, pricing
- Novartis 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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