Adasuve generics — when can they launch?
Adasuve (LOXAPINE) · · 1 active US patent · 0 expired
Where Adasuve sits in the generic timeline
All listed Orange Book patents for Adasuve have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
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 Adasuve drug page →
-
This patent protects a self-contained heating unit and drug-supply unit that rapidly heats a drug to a vapor.USPTO title: Self-contained heating unit and drug-supply unit employing same
Sources
- FDA Orange Book — patents listed against Adasuve (NDA filed 1975)
- Adasuve drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2026 — 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.
Get generic entry alerts
Free Pharma CI alerts on Adasuve — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →