Kyprolis generics — when can they launch?
Kyprolis (carfilzomib) · Amgen · 24 active US patents · 0 expired
Where Kyprolis sits in the generic timeline
All listed Orange Book patents for Kyprolis have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
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.
- Other — 12 patents
- Formulation — 6 patents
- Composition of Matter — 3 patents
- Method of Use — 3 patents
FDA U-codes carved out by Kyprolis 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-3449 | (no description) |
Sample patent estate
Showing 6 of 24 active US patents. View full estate on the Kyprolis drug page →
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This patent protects peptide-based compounds that inhibit specific activities of certain enzymes, including the chymotrypsin-like activity of the 20S proteasome.USPTO title: Compounds for enzyme inhibition
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This patent protects peptide-based compounds that inhibit specific activities of certain enzymes, including the chymotrypsin-like activity of the 20S proteasome.USPTO title: Compounds for enzyme inhibition
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This patent protects peptide-based compounds that inhibit specific activities of certain enzymes, including the chymotrypsin-like activity of the 20S proteasome.USPTO title: Compounds for enzyme inhibition
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This patent protects peptide-based compounds that inhibit specific activities of certain enzymes, including the chymotrypsin-like activity of the 20S proteasome.USPTO title: Compounds for enzyme inhibition
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This patent protects peptide-based compounds that inhibit specific activities of certain enzymes, including the chymotrypsin-like activity of the 20S proteasome.USPTO title: Compounds for enzyme inhibition
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This patent protects peptide-based compounds that inhibit specific activities of certain enzymes, including the chymotrypsin-like activity of the 20S proteasome.USPTO title: Compounds for enzyme inhibition
Sources
- FDA Orange Book — patents listed against Kyprolis (NDA filed 2012)
- Kyprolis drug profile — full patent estate, indications, clinical trials, pricing
- Amgen patent portfolio
- Patent cliff 2026 — 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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