Evrysdi generics — when can they launch?
Evrysdi (RISDIPLAM) · Roche · 13 active US patents · 0 expired
Where Evrysdi sits in the generic timeline
Long-dated protection: earliest active US patent for Evrysdi 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.
- Method of Use — 8 patents
- Composition of Matter — 4 patents
- Formulation — 1 patent
FDA U-codes carved out by Evrysdi 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-1943 | (no description) |
Sample patent estate
Showing 6 of 13 active US patents. View full estate on the Evrysdi drug page →
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This patent protects compounds of Formula (I) and their forms, compositions, and uses for treating spinal muscular atrophy.USPTO title: Compounds for treating spinal muscular atrophy
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This patent protects compounds of Formula (I) and their forms, compositions, and uses for treating spinal muscular atrophy.USPTO title: Compounds for treating spinal muscular atrophy
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This patent protects compounds of formula (I) and their use as medicaments, as well as their manufacture and pharmaceutical compositions.USPTO title: Compounds for treating spinal muscular atrophy
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This patent protects compounds of formula (I) and their use as medicaments, as well as their manufacture and pharmaceutical compositions.USPTO title: Compounds for treating spinal muscular atrophy
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This patent protects compounds of formula (I) and their use as medicaments, as well as their manufacture and pharmaceutical compositions.USPTO title: Compounds for treating spinal muscular atrophy
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This patent protects compounds of formula (I) and their use as medicaments, as well as their manufacture and pharmaceutical compositions.USPTO title: Compounds for treating spinal muscular atrophy
Sources
- FDA Orange Book — patents listed against Evrysdi (NDA filed 2020)
- Evrysdi drug profile — full patent estate, indications, clinical trials, pricing
- Roche 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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