Qalsody generics — when can they launch?
Qalsody (TOFERSEN) · Biogen Ma · 3 active US patents · 0 expired
Where Qalsody sits in the generic timeline
Long-dated protection: earliest active US patent for Qalsody extends to 2035 (~9 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 — 2 patents
- Composition of Matter — 1 patent
FDA U-codes carved out by Qalsody 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-3575 | (no description) |
Sample patent estate
Showing 3 of 3 active US patents. View full estate on the Qalsody drug page →
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This patent protects methods and compositions for decreasing SOD-1 expression to treat or prevent amyotrophic sclerosis (ALS) and other SOD-1 associated diseases.USPTO title: Compositions for modulating SOD-1 expression
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This patent protects methods and compositions for decreasing SOD-1 expression to treat or prevent SOD-1 associated diseases, including amyotrophic lateral sclerosis (ALS).USPTO title: Compositions for modulating SOD-1 expression
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This patent protects compositions that modulate SOD-1 expression, which can be used to treat or prevent amyotrophic sclerosis (ALS).USPTO title: Compositions for modulating SOD-1 expression
Sources
- FDA Orange Book — patents listed against Qalsody (NDA filed 2023)
- Qalsody drug profile — full patent estate, indications, clinical trials, pricing
- Biogen Ma patent portfolio
- Patent cliff 2035 — 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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