Luzu generics — when can they launch?
Luzu (LULICONAZOLE) · Bausch Health · 4 active US patents · 0 expired
Where Luzu sits in the generic timeline
Long-dated protection: earliest active US patent for Luzu extends to 2033 (~7 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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 — 1 patent
- Formulation — 1 patent
FDA U-codes carved out by Luzu 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-540 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Luzu drug page →
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This patent protects a crystal of luliconazole with a specific crystal habit that improves its solubility.USPTO title: Crystal having crystal habits and pharmaceutical composition obtained by processing the crystal
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This patent protects a crystal form of luliconazole, specifically one combined with a short chain alcohol having 1-4 carbon atoms, to improve its solubility.USPTO title: Crystal and pharmaceutical preparation containing the same crystal
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This patent protects a crystalline form of luliconazole with a specific crystal habit that improves its solubility.USPTO title: Crystalline form having specific crystal habit and pharmaceutical composition containing this crystalline form as active ingredient
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This patent protects a method for evaluating the stability of a pharmaceutical preparation containing luliconazole.USPTO title: Method of evaluating pharmaceutical preparation containing luliconazole and index substance
Sources
- FDA Orange Book — patents listed against Luzu (NDA filed 2013)
- Luzu drug profile — full patent estate, indications, clinical trials, pricing
- Bausch Health patent portfolio
- Patent cliff 2033 — 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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