US Patent

US8778924 — Modified release amoxicillin products

Method of Use · Assigned to Shionogi Inc · Expires 2026-12-08 · 1y remaining

Vulnerability score 80/100 Vulnerable — likely target for IPR or design-around

What this patent protects

This patent protects a modified release amoxicillin product that has a specific pharmacokinetic profile when taken with food.

USPTO Abstract

An amoxicillin product comprising: at least one modified release component(s), wherein the at least one modified release component(s) comprises at least amoxicillin and a pharmaceutically acceptable carrier; and wherein when administered to a patient or subject in the fed state said amoxicillin product exhibits a pharmacokinetic profile for amoxicillin in the plasma characterized as follows: (1) the ratio of the portion of the AUC as measured from 2 hours post-administration to 5 hours post-administration to the portion of the AUC as measured from administration to 2 hours post-administration is at least 2.0:1; and (2) the ratio of the portion of the AUC as measured from 5 hours post-administration to 12 hours post-administration to the portion of the AUC as measured from administration to 2 hours post-administration is at least 1.1:1.

Drugs covered by this patent

FDA Patent Use Codes

When a patent is method-of-use, FDA lists it once per applicable indication ("U-code"). Each U-code carves out a specific therapeutic use that generic filers must either license or design around.

CodeDescriptionDrug
U-897 Amoxil

Patent Metadata

Patent number
US8778924
Jurisdiction
US
Classification
Method of Use
Expires
2026-12-08
Drug substance claim
Yes
Drug product claim
Yes
Assignee
Shionogi Inc
Source
FDA Orange Book + USPTO grounding via Google Patents

Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.

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