Claims for Patent: 11,850,245

Summary for Patent: 11,850,245

Title:	Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Abstract:	Pharmaceutical formulations and methods for the topical or transdermal delivery of 1isobutyl-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 genital/perianal warts with shorter durations of therapy than currently prescribed for the commercially available for 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 genital/perianal warts with an acceptable safety profile and dosing regimens that are shorter 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 genital/perianal warts are also disclosed and described.
Inventor(s):	Michael T. Nordsiek, Jefferson J. Gregory
Assignee:	Medicis Pharmaceutical Corp
Application Number:	US17/177,116
Patent Claims:	1. A method of treating external genital or perianal warts in a population of patients 12 years old or older in need thereof in a treatment period of eight weeks or less, the method comprising topically applying a 3.75% (w/w) imiquimod composition to the genital or perianal warts once a day for up to eight consecutive weeks; wherein the treatment results in less than 10% incidents of severe erythema in the population. 2. The method of claim 1, wherein up to 9.375 mg of imiquimod is applied daily. 3. The method of claim 1, wherein up to 65.625 mg of imiquimod is applied weekly. 4. The method of claim 1, wherein up to 525 mg of imiquimod is applied in the eight treatment period. 5. The method of claim 1, wherein up to 250 mg of the imiquimod composition is applied to the warts each day.