Aczone generics — when can they launch?
Aczone (DAPSONE) · Almirall · 1 active US patent · 0 expired
Where Aczone sits in the generic timeline
Long-dated protection: earliest active US patent for Aczone extends to 2033 (~8 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 Aczone drug page →
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This patent protects topical compositions containing dapsone and/or adapalene in a polymeric viscosity builder for treating various dermatological conditions.USPTO title: Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Sources
- FDA Orange Book — patents listed against Aczone (NDA filed 1979)
- Aczone drug profile — full patent estate, indications, clinical trials, pricing
- Almirall 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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