Kerendia generics — when can they launch?
Kerendia (FINERENONE) · Bayer · 6 active US patents · 0 expired
Where Kerendia sits in the generic timeline
Long-dated protection: earliest active US patent for Kerendia extends to 2033 (~7 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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 — 6 patents
Sample patent estate
Showing 6 of 6 active US patents. View full estate on the Kerendia drug page →
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This patent protects novel substituted 4-aryl-1,4-dihydro-1,6-naphthyridine-3-carboxamides and their use in treating and preventing diseases, especially cardiovascular disorders.USPTO title: Substituted-4-aryl-1,4-dihydro-1,6-naphthyridinamides and use thereof
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This patent protects novel substituted 4-aryl-1,4-dihydro-1,6-naphthyridine-3-carboxamides and their use in treating and preventing diseases, especially cardiovascular disorders.USPTO title: Substituted-4-aryl-1,4-dihydro-1,6-naphthyridinamides and use thereof
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This patent protects novel substituted 4-aryl-1,4-dihydro-1,6-naphthyridine-3-carboxamides and their use in treating and preventing diseases, especially cardiovascular disorders.USPTO title: Substituted-4-aryl-1,4-dihydro-1,6-naphthyridinamides and use thereof
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This patent protects the composition of matter of the active drug substance known as Kerendia.
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This patent protects the composition of matter of the active drug substance known as Kerendia.
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This patent protects the composition of matter of the active drug substance known as Kerendia.
Sources
- FDA Orange Book — patents listed against Kerendia (NDA filed 2021)
- Kerendia drug profile — full patent estate, indications, clinical trials, pricing
- Bayer patent portfolio
- Patent cliff 2033 — 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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