HYDROXYUREA generics — when can they launch?
HYDROXYUREA (HYDROXYUREA) · · 1 active US patent · 0 expired
Where HYDROXYUREA sits in the generic timeline
Long-dated protection: earliest active US patent for HYDROXYUREA extends to 2041 (~16 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 — 1 patent
Sample patent estate
Showing 1 of 1 active US patents. View full estate on the HYDROXYUREA drug page →
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This patent protects a stable aqueous solution of hydroxycarbamide that can be safely stored at ambient temperatures for a prolonged period.USPTO title: Stable aqueous hydroxycarbamide solution
Sources
- FDA Orange Book — patents listed against HYDROXYUREA (NDA filed 1967)
- HYDROXYUREA drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2041 — 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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