Fycompa generics — when can they launch?
Fycompa (PERAMPANEL) · Catalyst Pharms · 7 active US patents · 0 expired
Where Fycompa sits in the generic timeline
All listed Orange Book patents for Fycompa 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.
- Composition of Matter — 7 patents
Sample patent estate
Showing 6 of 7 active US patents. View full estate on the Fycompa drug page →
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This patent protects a method for commercially producing a specific 1,2-dihydropyridine-2-one compound, including crystals of 3-(2-cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one.USPTO title: Method for producing 1, 2-dihydropyridine-2-one compound
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This patent protects a method for commercially producing a specific 1,2-dihydropyridine-2-one compound, including crystals of 3-(2-cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one.USPTO title: Method for producing 1, 2-dihydropyridine-2-one compound
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This patent protects a method for commercially producing a specific 1,2-dihydropyridine-2-one compound, including crystals of 3-(2-cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one.USPTO title: Method for producing 1, 2-dihydropyridine-2-one compound
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This patent protects a method for commercially producing a specific 1,2-dihydropyridine-2-one compound, including crystals of 3-(2-cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one.USPTO title: Method for producing 1, 2-dihydropyridine-2-one compound
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This patent protects a method for commercially producing a specific 1,2-dihydropyridine-2-one compound, including crystals of 3-(2-cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one.USPTO title: Method for producing 1, 2-dihydropyridine-2-one compound
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This patent protects a method for commercially producing a specific 1,2-dihydropyridine-2-one compound, including crystals of 3-(2-cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one.USPTO title: Method for producing 1, 2-dihydropyridine-2-one compound
Sources
- FDA Orange Book — patents listed against Fycompa (NDA filed 2012)
- Fycompa drug profile — full patent estate, indications, clinical trials, pricing
- Catalyst Pharms patent portfolio
- 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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