US Patent

US11458104 — Enteric coated tiopronin tablet

Method of Use · Assigned to Mission Pharmacal Co · Expires 2038-11-14 · 12y remaining

Vulnerability score 70/100 Vulnerable — likely target for IPR or design-around

What this patent protects

This patent protects a solid pharmaceutical composition that includes an enteric-coated tiopronin tablet with a specific design to maintain tiopronin levels after oral administration.

USPTO Abstract

A solid pharmaceutical composition is provided that includes a core, an inner coating, and an outer coating. The core includes tiopronin as an active agent. Further, the inner coating, which includes a cellulose-based polymer, surrounds the core, and the outer coating, which includes an enteric polymer, surrounds the inner coating. As a result of the specific components of the solid pharmaceutical composition, the solid pharmaceutical composition exhibits a fed state Cmax of tiopronin that is at least 70% of a 12-hour fasted state Cmax of tiopronin after oral administration of the solid pharmaceutical composition when administered as a 300 milligram dose. As such, it is possible for the solid pharmaceutical composition to be administered orally with or without food (e.g., in a fed or fasted state) while still achieving a desired maximum plasma concentration of the tiopronin in a delayed release formulation.

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-3441 —
U-3441 —

Patent Metadata

Patent number
US11458104
Jurisdiction
US
Classification
Method of Use
Expires
2038-11-14
Drug substance claim
No
Drug product claim
No
Assignee
Mission Pharmacal Co
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.

Track this patent

Get a daily-checked alert when vulnerability score, expiry, classification, or assignee changes. Email, Slack, or Teams delivery. Pro: 50 watches, Free: 3.