ASENAPINE MALEATE generics — when can they launch?
ASENAPINE MALEATE (ASENAPINE MALEATE) · · 6 active US patents · 6 expired
Where ASENAPINE MALEATE sits in the generic timeline
All listed Orange Book patents for ASENAPINE MALEATE 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.
- Other — 6 patents
Sample patent estate
Showing 6 of 6 active US patents. View full estate on the ASENAPINE MALEATE drug page →
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This patent protects an orthorhombic crystal form of asenapine maleate, a method for preparing it, and pharmaceutical compositions containing this crystal form.USPTO title: Crystal form of asenapine maleate
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This patent protects an orthorhombic crystal form of asenapine maleate, a method for preparing it, and pharmaceutical compositions containing this crystal form.USPTO title: Crystal form of asenapine maleate
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This patent protects an orthorhombic crystal form of asenapine maleate, a method for preparing it, and pharmaceutical compositions containing this crystal form.USPTO title: Crystal form of asenapine maleate
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This patent protects an orthorhombic crystal form of asenapine maleate, a method for preparing it, and pharmaceutical compositions containing this crystal form.USPTO title: Crystal form of asenapine maleate
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This patent protects an orthorhombic crystal form of asenapine maleate, a method for preparing it, and pharmaceutical compositions containing this crystal form.USPTO title: Crystal form of asenapine maleate
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This patent protects an orthorhombic crystal form of asenapine maleate, a method for preparing it, and pharmaceutical compositions containing this crystal form.USPTO title: Crystal form of asenapine maleate
Sources
- FDA Orange Book — patents listed against ASENAPINE MALEATE (NDA filed 2009)
- ASENAPINE MALEATE 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.
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