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Last Updated: December 12, 2025

Claims for Patent: 10,471,072

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Summary for Patent: 10,471,072

Title:	Vaginal inserted estradiol pharmaceutical compositions and methods
Abstract:	In one aspect, pharmaceutical compositions and methods for the treatment of vulvovaginal atrophy (VVA) are provided. In one embodiment, the method comprises digitally inserting into the lower third of the vagina of a subject having VVA a soft gelatin capsule containing a liquid pharmaceutical composition.
Inventor(s):	Brian A. Bernick, Peter H. R. Persicaner, Janice Louise Cacace, Neda Irani, Julia M. Amadio
Assignee:	TherapeuticsMD Inc
Application Number:	US15/893,550
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,471,072
Patent Claims:	1. A method for treating moderate to severe dyspareunia in a human subject, the method comprising: inserting about two inches into the vagina of the subject a soft gelatin capsule containing a liquid pharmaceutical composition, wherein the composition comprises about 4 μg to about 25 μg of estradiol and an excipient that increases the viscosity of the composition, wherein the composition has a viscosity from about 50 cP to about 1000 cP at 25° C., and wherein the composition spreads over the vaginal tissue and the estradiol is absorbed by the vaginal tissue. 2. The method of claim 1, wherein the subject is in a reclined position while inserting the soft gelatin capsule. 3. The method of claim 1, wherein the subject is in a standing position while inserting the soft gelatin capsule. 4. The method of claim 1, wherein the viscosity of the composition is from about 50 cP to about 380 cP at 25° C. 5. The method of claim 1, wherein the excipient that increases the viscosity comprises polyethylene glycol long chain saturated fatty acid esters, ethylene glycol long chain saturated fatty acid esters, or a mixture thereof. 6. The method of claim 1, wherein the composition comprises 4 μg estradiol or 10 μg estradiol. 7. The method of claim 1, wherein the soft gelatin capsule is inserted once daily for two weeks and twice weekly thereafter.

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