US Patent

US11992480 — Method for reducing side effects from administration of phosphodiesterase-4 inhibitors

Method of Use · Assigned to Arcutis Biotherapeutics Inc · Expires 2037-06-07 · 11y remaining

Vulnerability score 75/100 Vulnerable — likely target for IPR or design-around

What this patent protects

This patent protects a method of reducing gastrointestinal side effects from a PDE-4 inhibitor, such as roflumilast, by topically administering it with phosphate ester surfactants.

USPTO Abstract

A method for altering the PK profile of a pharmaceutical formulation containing a PDE-4 inhibitor, such as roflumilast, to reduce the spike in Cmax. The spike in Cmax is reduced by topically administering the PDE-4 inhibitor in combination with one or more phosphate ester surfactants. Reducing the spike in Cmax will reduce gastrointestinal side effects and result in better patient compliance.

Drugs covered by this patent

Daliresp (ROFLUMILAST) · Arcutis

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-3970`	—	Daliresp
`U-4301`	—	Daliresp
`U-4203`	—	Daliresp
`U-3748`	—	Daliresp

Patent Metadata

Patent number: US11992480
Jurisdiction: US
Classification: Method of Use
Expires: 2037-06-07
Drug substance claim: No
Drug product claim: No
Assignee: Arcutis Biotherapeutics 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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