CHLORHEXIDINE GLUCONATE generics — when can they launch?
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE GLUCONATE) · · 4 active US patents · 1 expired
Where CHLORHEXIDINE GLUCONATE sits in the generic timeline
Imminent generic cliff: earliest active US patent for CHLORHEXIDINE GLUCONATE 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 — 4 patents
FDA U-codes carved out by CHLORHEXIDINE GLUCONATE 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-1397 | (no description) |
U-1022 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the CHLORHEXIDINE GLUCONATE drug page →
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This patent protects an applicator for coloring antiseptic solutions by transferring colorant to the antiseptic as it flows through a porous element.USPTO title: Applicator for coloring antiseptic
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This patent protects an applicator for coloring antiseptic solutions by transferring colorant to the antiseptic as it flows through a porous element.USPTO title: Applicator for coloring antiseptic
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This patent protects an applicator for coloring antiseptic solutions by transferring colorant to the antiseptic as it flows through a porous element.USPTO title: Applicator for coloring antiseptic
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This patent protects a disinfectant delivery system and method using a blended cloth impregnated with an alcohol-free disinfectant solution containing chlorhexidine gluconate.USPTO title: Disinfectant delivery system and method of providing alcohol-free disinfection
Sources
- FDA Orange Book — patents listed against CHLORHEXIDINE GLUCONATE (NDA filed 1976)
- CHLORHEXIDINE GLUCONATE 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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