Viltepso generics — when can they launch?
Viltepso (VILTOLARSEN) · Nippon Shinyaku · 2 active US patents · 0 expired
Where Viltepso sits in the generic timeline
Mid-term cliff: earliest active US patent for Viltepso 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.
- Method of Use — 1 patent
- Composition of Matter — 1 patent
FDA U-codes carved out by Viltepso 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-3039 | (no description) |
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Viltepso drug page →
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This patent protects an oligomer and pharmaceutical composition that cause skipping of the 53rd exon in the human dystrophin gene.USPTO title: Antisense nucleic acids
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This patent protects an oligomer that causes skipping of the 53rd exon in the human dystrophin gene and a pharmaceutical composition that achieves this with high efficiency.USPTO title: Antisense nucleic acids
Sources
- FDA Orange Book — patents listed against Viltepso (NDA filed 2020)
- Viltepso drug profile — full patent estate, indications, clinical trials, pricing
- Nippon Shinyaku 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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