US Patent

US10238644 — 2×2×2 week dosing regimen for treating acting keratosis with pharmaceutical compositions formulated with 3.75% imiquimod

Method of Use · Assigned to Medicis Pharmaceutical Corp · Expires 2029-12-11 · 4y remaining

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

What this patent protects

This patent protects a 2x2x2 week dosing regimen for treating actinic keratosis with a 3.75% imiquimod pharmaceutical composition.

USPTO Abstract

Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, i.e., imiquimod, to treat actinic keratosis with short durations of therapy, than currently prescribed for the commercially available Aldara® 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration (“FDA”), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating actinic keratosis with an acceptable safety profile and dosing regimens that are short and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration (“FDA”) for Aldara® 5% imiquimod cream to treat actinic keratosis are also disclosed and described.

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-68 Aldara

Patent Metadata

Patent number
US10238644
Jurisdiction
US
Classification
Method of Use
Expires
2029-12-11
Drug substance claim
No
Drug product claim
No
Assignee
Medicis Pharmaceutical 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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