Details for Patent: 10,918,635

Which drugs does patent 10,918,635 protect, and when does it expire?

Patent 10,918,635 protects ZYCLARA and is included in one NDA.

This patent has twenty-two patent family members in nineteen countries.

Summary for Patent: 10,918,635

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:	US16/364,023
Patent Claim Types: see list of patent claims	Use; Formulation;

US Patent 10,918,635: Claim Scope, Exclusivity, Litigation Risk, and Imiquimod Patent Landscape

US Patent No. 10,918,635 protects a narrow method of treating external genital or perianal warts with a specific 3.75% imiquimod cream formulation. The independent claim requires four elements: a patient at least 12 years old, the target wart location, once-daily topical administration, and use of one of the listed excipient compositions containing a permitted fatty acid. The dependent claims establish daily, weekly, and eight-week imiquimod exposure limits.

The patent does not broadly cover all imiquimod products, all 3.75% creams, or all wart treatments. Its practical value depends on whether a competing product uses a covered formulation and whether the competitor’s proposed label or actual use directs the claimed dosing regimen.

What does US Patent 10,918,635 protect?

US 10,918,635 protects a treatment method rather than imiquimod as a chemical compound. Claim 1 requires the following combination:

Claim element	Required limitation
Patient	At least 12 years old
Condition	External genital or perianal wart
Administration	Topical application
Dose form	3.75% w/w imiquimod cream
Amount of cream	Up to 250 mg
Frequency	Once daily
Treatment formulation	One of the listed Formulations 181-198
Fatty acid	Palmitic, linoleic, stearic, isostearic,

Drugs Protected by US Patent 10,918,635

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes	10,918,635					TREATMENT OF GENITAL WARTS
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes	10,918,635					TREATMENT OF PERIANAL WARTS

International Family Members for US Patent 10,918,635

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	077747
Australia	2010274097
Brazil	112012000797
Canada	2697978