Claims for Patent: 9,301,920

Summary for Patent: 9,301,920

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:	13/843,428
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,301,920
Patent Claims:	1. A pharmaceutical formulation for administering estradiol and progesterone to a mammal in need thereof, comprising solubilized estradiol, solubilized progesterone, suspended progesterone, and an oil, wherein each of the solubilized estradiol, the solubilized progesterone, and the suspended progesterone is present in the oil, and wherein the oil comprises medium chain fatty acid esters of glycerol, polyethylene glycol, or propylene glycol, or mixtures thereof, wherein the medium chain fatty acid esters are predominantly esters of C6 to C12 fatty acids. 2. The pharmaceutical formulation of claim 1 wherein the oil comprises medium chain fatty acid esters of glycerol, polyethylene glycol, or propylene glycol, or mixtures thereof, and wherein the medium chain fatty acid esters are predominantly esters of C6 to C10 fatty acids. 3. The pharmaceutical formulation of claim 1 wherein the oil is predominantly mono- and diglycerides. 4. The pharmaceutical formulation of claim 1 wherein at least 90% of the total estradiol is solubilized. 5. The pharmaceutical formulation of claim 1 further comprising a surfactant. 6. The pharmaceutical formulation of claim 5 wherein the surfactant is a non-ionic surfactant. 7. The pharmaceutical formulation of claim 6 wherein the surfactant is lauroyl polyoxyl-32-glycerides. 8. The pharmaceutical formulation of claim 1 comprising: 30 to 35 wt % progesterone, 0.1 to 0.4 wt % estradiol 55 to 75 wt % of the oil, wherein the oil is predominantly medium chain fatty acid mono- and diglycerides, and 0.5 to 10wt % non-ionic surfactant. 9. The pharmaceutical formulation of claim 8 further comprising gelatin, glycerol, and coloring agents. 10. The pharmaceutical formulation of claim 1 wherein the progesterone is released more rapidly than progesterone in peanut oil. 11. The pharmaceutical formulation of claim 1 wherein the oil comprises medium chain fatty acid esters of glycerol, polyethylene glycol, or propylene glycol, or mixtures thereof, and wherein the medium chain fatty acid esters are predominantly esters of C8 to C12 fatty acids. 12. The pharmaceutical formulation of claim 1 wherein the oil comprises medium chain fatty acid esters of glycerol, polyethylene glycol, or propylene glycol, or mixtures thereof, and wherein the medium chain fatty acid esters are predominantly esters of C8 to C10 fatty acids. 13. A method of treating at least one progesterone-deficient state in a mammal in need of treatment comprising administering an effective amount of a pharmaceutical formulation of claim 1. 14. A method of treating at least one estrogen-deficient state in a mammal in need of treatment comprising administering an effective amount of a pharmaceutical formulation of claim 1.