Fusilev generics — when can they launch?
Fusilev (levoleucovorin) · Acrotech Biopharma · 2 active US patents · 0 expired
Where Fusilev sits in the generic timeline
Long-dated protection: earliest active US patent for Fusilev extends to 2039 (~13 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.
- Formulation — 2 patents
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Fusilev drug page →
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This patent protects compositions of disodium levofolinate, including methods for preparing them and using them to treat folic acid deficiency and cancer.USPTO title: Compositions comprising disodium levofolinate
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This patent protects compositions of disodium levofolinate, including methods for preparing them and using them to treat folic acid deficiency and cancer.USPTO title: Compositions comprising disodium levofolinate
Sources
- FDA Orange Book — patents listed against Fusilev (NDA filed 2008)
- Fusilev drug profile — full patent estate, indications, clinical trials, pricing
- Acrotech Biopharma patent portfolio
- Patent cliff 2039 — 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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