Ztalmy generics — when can they launch?
Ztalmy (GANAXOLONE) · Marinus · 11 active US patents · 0 expired
Where Ztalmy sits in the generic timeline
Imminent generic cliff: earliest active US patent for Ztalmy expires in 2026 (~1 year from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
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 — 6 patents
- Formulation — 5 patents
FDA U-codes carved out by Ztalmy 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-3374 | (no description) |
U-4034 | (no description) |
Sample patent estate
Showing 6 of 11 active US patents. View full estate on the Ztalmy drug page →
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This patent protects stable ganaxolone particles with a volume-weighted median diameter of 50-500 nanometers.USPTO title: Solid ganaxolone formulations and methods for the making and use thereof
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This patent protects stable ganaxolone particles with a volume-weighted median diameter of 50-500 nanometers.USPTO title: Solid ganaxolone formulations and methods for the making and use thereof
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This patent protects a formulation of ganaxolone in the form of stable particles with a specific size range.USPTO title: Solid ganaxolone compositions and methods for the making and use thereof
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This patent protects methods for making and using solid formulations of ganaxolone, specifically particles with a diameter of about 50 nm to about 500 nm.USPTO title: Solid ganaxolone formulations and methods for the making and use thereof
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This patent protects methods for making and using liquid formulations of ganaxolone, specifically those with stable particles of a certain size.USPTO title: Liquid ganaxolone formulations and methods for the making and use thereof
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This patent protects liquid formulations of ganaxolone with stable particles having a volume-weighted median diameter of 50-500 nanometers.USPTO title: Liquid ganaxolone formulations and methods for the making and use thereof
Sources
- FDA Orange Book — patents listed against Ztalmy (NDA filed 2022)
- Ztalmy drug profile — full patent estate, indications, clinical trials, pricing
- Marinus 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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