US Patent

US8808740 — Encased tamper resistant controlled release dosage forms

Method of Use · Assigned to Purdue Pharma LP · Expires 2031-12-21 · 6y remaining

Vulnerability score 56/100 Moderate — design-around opportunities exist

What this patent protects

This patent protects a controlled-release dosage form of an opioid analgesic, specifically hydrocodone bitartrate, that releases the medication in a proportional amount over 8 to 24 hours.

USPTO Abstract

In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 C.

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-1556 hydrocodone-bitartrate
U-1556 hydrocodone-bitartrate
U-1556 hydrocodone-bitartrate
U-1556 hydrocodone-bitartrate
U-1556 hydrocodone-bitartrate
U-1556 hydrocodone-bitartrate
U-1556 hydrocodone-bitartrate

Patent Metadata

Patent number
US8808740
Jurisdiction
US
Classification
Method of Use
Expires
2031-12-21
Drug substance claim
No
Drug product claim
Yes
Assignee
Purdue Pharma LP
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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