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Last Updated: April 5, 2025

Claims for Patent: 8,633,178

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Summary for Patent: 8,633,178

Title:	Natural combination hormone replacement formulations and therapies
Abstract:	Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.
Inventor(s):	Bernick; Brian A. (Boca Raton, FL), Cacace; Janice Louise (Miami, FL), Persicaner; Peter H. R. (Boca Raton, FL), Irani; Neda (Palm Beach Garden, FL), Amadio; Julia M. (Boca Raton, FL)
Assignee:	TherapeuticsMD, Inc. (Boca Raton, FL)
Application Number:	13/684,002
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,633,178
Patent Claims:	1. A pharmaceutical formulation comprising solubilized estradiol, suspended progesterone, and a medium chain solubilizing agent; wherein each of the estradiol and the suspended progesterone are present in the solubilizing agent and the estradiol and the suspended progesterone are uniformly dispersed; wherein at least about 90% of the estradiol is solubilized in the solubilizing agent; and wherein the solubilizing agent comprises a C6-C12 oil. 2. The pharmaceutical formulation of claim 1, further comprising partially solubilized progesterone. 3. The pharmaceutical formulation of claim 1, wherein the formulation is contained within a gelatin capsule. 4. The pharmaceutical formulation of claim 1, wherein the medium chain solubilizing agent is selected from at least one of mono-, di-, and triglycerides and combinations thereof. 5. The pharmaceutical formulation of claim 1, wherein said estrogen has a dosage strength at least about 0.125 mg and wherein said progesterone has a dosage strength at least about 25 mg. 6. The pharmaceutical formulation of claim 1, wherein the ratio of progesterone to estradiol is at least 95:1.

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