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Last Updated: June 2, 2024

Claims for Patent: 11,266,661

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Summary for Patent: 11,266,661

Title:	Vaginal inserted estradiol pharmaceutical compositions and methods
Abstract:	Disclosed herein is, among other things, a soft gel vaginal pharmaceutical composition and dosage form containing solubilized estradiol for the treatment of vulvovaginal atrophy (VVA) and female sexual dysfunction (FSD).
Inventor(s):	Mirkin; Sebastian (Boca Raton, FL), Amadio; Julia M. (Boca Raton, FL), Bernick; Brian (Boca Raton, FL)
Assignee:	TherapeuticsMD, Inc. (Boca Raton, FL)
Application Number:	15/781,840
Patent Claims:	1. A method for treating vaginal dryness, the method comprising administering to a female subject in need thereof, a vaginal suppository comprising: (a) a liquid composition comprising: a therapeutically effective amount of estradiol; a caprylic/capric triglyceride; a non-ionic surfactant comprising PEG-6 stearate or ethylene glycol palmitostearate; and (b) a soft gelatin capsule; wherein the vaginal suppository includes from about 1 microgram to about 25 micrograms of estradiol; and wherein estradiol is the only active hormone in the vaginal suppository. 2. The method of claim 1, wherein the vaginal suppository does not include a hydrophilic gel-forming bioadhesive agent in the liquid composition. 3. The method of claim 1, wherein the suppository is administered to the subject daily for two weeks, and twice weekly thereafter. 4. The method of claim 1, wherein the suppository includes about 10 ug of estradiol. 5. The method of claim 1, wherein the suppository includes about 25 ug of estradiol. 6. A method for treating dyspareunia, the method comprising administering to a female subject in need thereof, a vaginal suppository comprising: (a) a liquid composition comprising: a therapeutically effective amount of estradiol; a caprylic/capric triglyceride; a non-ionic surfactant comprising PEG-6 stearate or ethylene glycol palmitostearate; and (b) a soft gelatin capsule; wherein the vaginal suppository includes from about 1 microgram to about 25 micrograms of estradiol; and wherein estradiol is the only active hormone in the vaginal suppository. 7. The method of claim 6, wherein the vaginal suppository does not include a hydrophilic gel-forming bioadhesive agent in the liquid composition. 8. The method of claim 6, wherein the suppository is administered to the subject daily for two weeks, and twice weekly thereafter. 9. The method of claim 6, wherein the suppository includes about 10 ug of estradiol. 10. The method of claim 6, wherein the suppository includes about 25 ug of estradiol.

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