Xeglyze generics — when can they launch?
Xeglyze (ABAMETAPIR) · Hatchtech · 2 active US patents · 0 expired
Where Xeglyze sits in the generic timeline
All listed Orange Book patents for Xeglyze 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.
- Method of Use — 2 patents
FDA U-codes carved out by Xeglyze 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-2863 | (no description) |
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Xeglyze drug page →
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This patent protects a method for inhibiting the hatching of ectoparasite eggs using a metal chelating agent or metalloprotease inhibitor.USPTO title: Methods and compositions for controlling ectoparasites
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This patent protects a pediculicidal composition and methods for using it to treat human head lice and their eggs.USPTO title: Pediculicidal composition
Sources
- FDA Orange Book — patents listed against Xeglyze (NDA filed 2020)
- Xeglyze drug profile — full patent estate, indications, clinical trials, pricing
- Hatchtech 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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