US Patent

US8835460 — Sublingual fentanyl spray and methods of treating pain

Method of Use · Assigned to Insys Therapeutics Inc · Expires 2027-01-25 · 1y remaining

Vulnerability score 68/100 Moderate — design-around opportunities exist

What this patent protects

This patent protects sublingual formulations containing fentanyl for administration to a patient and methods for treating pain with these formulations.

USPTO Abstract

The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.

Drugs covered by this patent

Duragesic (fentanyl) · Johnson & Johnson (Janssen Pharmaceutica)

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.

Code	Description	Drug
`U-55`	—	Duragesic
`U-55`	—	Duragesic
`U-55`	—	Duragesic
`U-55`	—	Duragesic
`U-55`	—	Duragesic
`U-55`	—	Duragesic
`U-55`	—	Duragesic

Patent Metadata

Patent number: US8835460
Jurisdiction: US
Classification: Method of Use
Expires: 2027-01-25
Drug substance claim: No
Drug product claim: Yes
Assignee: Insys Therapeutics 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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