Lignospan Forte generics — when can they launch?
Lignospan Forte (Lidocaine Hydrochloride) · Fresenius Kabi · 4 active US patents · 0 expired
Where Lignospan Forte sits in the generic timeline
All listed Orange Book patents for Lignospan Forte 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 — 4 patents
FDA U-codes carved out by Lignospan Forte 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-1523 | (no description) |
U-1438 | (no description) |
U-1870 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Lignospan Forte drug page →
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This patent protects a stable aqueous gel formulation for inducing topical anesthesia and a method of using it on animal tissues or organs.USPTO title: Aqueous gel formulation and method for inducing topical anesthesia
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This patent protects a manufacturing article used to make particle cassettes with gas flow passages.USPTO title: Particle cassettes and processes therefor
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This patent protects a manufacturing article used to make particle cassettes with gas flow passages.USPTO title: Particle cassettes and processes therefor
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This patent protects systems, devices, and methods for delivering therapeutic particles, including a device with a gas supply and safety features.USPTO title: Devices and methods for delivering particles
Sources
- FDA Orange Book — patents listed against Lignospan Forte (NDA filed 1948)
- Lignospan Forte drug profile — full patent estate, indications, clinical trials, pricing
- Fresenius Kabi 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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