US Patent

US11400019 — Sustained release drug delivery systems with reduced impurities and related methods

Formulation · Assigned to Durect Corp · Expires 2041-01-12 · 15y remaining

Vulnerability score 50/100 Moderate — design-around opportunities exist

What this patent protects

This patent protects sustained release drug delivery systems with reduced impurities for pharmaceutical agents, including formulations with specific components and levels.

USPTO Abstract

The present disclosure relates to sustained release drug delivery systems. In some cases, a composition comprises an active pharmaceutical agent; at least one of sucrose acetate isobutyrate and a polyorthoester; an organic solvent; and 2,6-dimethylaniline, wherein the 2,6-dimethylaniline is present at a level less than 500 ppm. In some cases, a composition comprises N-oxide of active pharmaceutical agent at a level less than 1 wt %, based on weight of the composition. In some case, a composition comprises metal present at a level less than 5 ppm. Dosage forms and methods are also provided.

Drugs covered by this patent

Patent Metadata

Patent number
US11400019
Jurisdiction
US
Classification
Formulation
Expires
2041-01-12
Drug substance claim
No
Drug product claim
Yes
Assignee
Durect Corp
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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