Ecclock generics — when can they launch?
Ecclock (SOFPIRONIUM BROMIDE) · Kaken Pharmaceutical · 20 active US patents · 0 expired
Where Ecclock sits in the generic timeline
All listed Orange Book patents for Ecclock 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 — 17 patents
- Composition of Matter — 3 patents
FDA U-codes carved out by Ecclock 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-2398 | (no description) |
Sample patent estate
Showing 6 of 20 active US patents. View full estate on the Ecclock drug page →
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This patent protects a class of compounds known as soft anticholinergic esters with specific chemical formulas.USPTO title: Soft anticholinergic esters
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This patent protects a class of soft anticholinergic ester compounds with specific chemical structures and configurations.USPTO title: Soft anticholinergic esters
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This patent protects a method of treating hyperhidrosis by topically administering a composition containing a specific compound to the skin before bedtime.USPTO title: Method of dosing and use of soft anticholinergic esters
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This patent protects a method of treating hyperhidrosis in mammals by topically administering a composition containing a specific compound to the skin before bedtime.USPTO title: Method of dosing and use of soft anticholinergic esters
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This patent protects a method of treating hyperhidrosis in mammals by topically administering a composition containing a specific compound to the skin before bedtime.USPTO title: Method of dosing and use of soft anticholinergic esters
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This patent protects a method of treating hyperhidrosis in mammals by topically applying a specific compound to the skin before bedtime.USPTO title: Method of dosing and use of soft anticholinergic esters
Sources
- FDA Orange Book — patents listed against Ecclock (NDA filed 2024)
- Ecclock drug profile — full patent estate, indications, clinical trials, pricing
- Kaken Pharmaceutical 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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