GIVINOSTAT HYDROCHLORIDE generics — when can they launch?
GIVINOSTAT HYDROCHLORIDE (GIVINOSTAT HYDROCHLORIDE) · · 4 active US patents · 0 expired
Where GIVINOSTAT HYDROCHLORIDE sits in the generic timeline
Imminent generic cliff: earliest active US patent for GIVINOSTAT HYDROCHLORIDE expires in 2027 (~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 — 3 patents
- Composition of Matter — 1 patent
FDA U-codes carved out by GIVINOSTAT HYDROCHLORIDE 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-3885 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the GIVINOSTAT HYDROCHLORIDE drug page →
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This patent protects a compound with formula (I) and a process for its preparation.USPTO title: Monohydrate hydrochloride of the 4-hydroxycarbamoyl-phenyl)-carbamic acid (6-diethylaminomethyl-naphtalen-2-yl) ester
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This patent protects a method for treating muscular dystrophy by administering diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride.USPTO title: Diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride for use in the treatment of muscular dystrophy
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This patent protects a method for treating muscular dystrophy by administering diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride.USPTO title: Diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride for use in the treatment of muscular dystrophy
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This patent discloses physically and chemically stable oral liquid formulations of Givinostat, specifically aqueous suspensions suitable for oral administration.USPTO title: Physically and chemically stable oral suspensions of givinostat
Sources
- FDA Orange Book — patents listed against GIVINOSTAT HYDROCHLORIDE (NDA filed 2024)
- GIVINOSTAT HYDROCHLORIDE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2027 — 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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