Horizant generics — when can they launch?
Horizant (GABAPENTIN ENACARBIL) · Azurity · 4 active US patents · 2 expired
Where Horizant sits in the generic timeline
All listed Orange Book patents for Horizant 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 — 2 patents
- Method of Use — 2 patents
FDA U-codes carved out by Horizant patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-1231 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Horizant drug page →
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This patent protects a crystalline form of a gamma-aminobutyric acid analog.USPTO title: Crystalline form of γ-aminobutyric acid analog
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This patent protects a crystalline form of a gamma-aminobutyric acid analog.USPTO title: Crystalline form of γ-aminobutyric acid analog
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This patent discloses sustained release oral dosage forms of a gabapentin prodrug, specifically 1-{[(α-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexane acetic acid.USPTO title: GABA analog prodrug sustained release oral dosage forms
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This patent discloses sustained release oral dosage forms of a gabapentin prodrug, specifically 1-{[(α-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexane acetic acid.USPTO title: GABA analog prodrug sustained release oral dosage forms
Sources
- FDA Orange Book — patents listed against Horizant (NDA filed 2011)
- Horizant drug profile — full patent estate, indications, clinical trials, pricing
- Azurity 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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