Claims for Patent: 9,006,222

Summary for Patent: 9,006,222

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:	14/099,623
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,006,222
Patent Claims:	1. A pharmaceutical composition comprising: a solubilizing agent, the solubilizing agent comprising an effective amount of a C6-C12 oil; 1.0 mg estradiol or 1.03 mg estradiol hemihydrate, the estradiol or estradiol hemihydrate being at least about 90% solubilized in the solubilizing agent; and 100 mg progesterone; wherein the estradiol or the estradiol hemihydrate, and the progesterone are uniformly dispersed in the solubilizing agent. 2. The pharmaceutical composition of claim 1, wherein the solubilizing agent is selected from at least one of monoglycerides, diglycerides, triglycerides, and combinations thereof, wherein the monoglycerides, diglycerides, and triglycerides are predominantly of C6-C12 fatty acid chain lengths. 3. The pharmaceutical composition of claim 2, wherein the monoglycerides, diglycerides, and triglycerides are >50% C6-C12 fatty acid chain lengths. 4. A pharmaceutical composition comprising: about 100 mg progesterone; about 1.0 mg estradiol or 1.03 mg estradiol hemihydrate, the estradiol or estradiol hemihydrate being at least about 90% solubilized; about 195.97 mg of monoglycerides and diglycerides of caprylic acid and capric acid (CAPMUL MCM); and about 3.0 mg of at least one of lauroyl macrogol-32 glycerides EP, lauroyl polyoxyl-32 glycerides NF, or lauroyl polyoxylglycerides (GELUCIRE 44/14); wherein the estradiol or the estradiol hemihydrate, and the progesterone are uniformly dispersed in the solubilizing agent. 5. A method of treating a menopause-related symptom in a woman comprising administering an effective amount of pharmaceutical composition to a subject in need thereof, the pharmaceutical composition comprising: about 100 mg progesterone; about 1.0 mg estradiol or 1.03 mg estradiol hemihydrate, the estradiol or estradiol hemihydrate being at least about 90% solubilized; about 195.97 mg of monoglycerides and diglycerides of caprylic acid and capric acid (CAPMUL MCM); and about 3.0 mg of at least one of lauroyl macrogol-32 glycerides EP, lauroyl polyoxyl-32 glycerides NF, or lauroyl polyoxylglycerides (GELUCIRE 44/14); wherein the estradiol or the estradiol hemihydrate, and the progesterone are uniformly dispersed in the solubilizing agent. 6. The method of claim 5, wherein the pharmaceutical composition is administered as a continuous-combined therapy regimen. 7. The method of claim 5, wherein the pharmaceutical composition is administered a sequentially-combined therapy regimen. 8. A method of treating a vasomotor symptom in a woman comprising administering an effective amount of a pharmaceutical composition comprising: 1.0 mg estradiol or 1.03 mg estradiol hemihydrate, the estradiol or estradiol hemihydrate being at least about 90% solubilized in the solubilizing agent; 100 mg progesterone; and a solubilizing agent, the solubilizing agent comprising an effective amount of a C6-C12 oil; wherein the estradiol or the estradiol hemihydrate, and the progesterone are uniformly dispersed in the solubilizing agent; and wherein the pharmaceutical composition is administered once daily for the treatment of symptoms associated with menopause. 9. The method of claim 8, wherein the pharmaceutical composition is administered as a continuous-combined therapy regimen. 10. The method of claim 8, wherein the pharmaceutical composition is administered as a sequentially-combined therapy regimen. 11. The method of claim 8, wherein the solubilizing agent is selected from at least one of monoglycerides, diglycerides, triglycerides, and combinations thereof, wherein the monoglycerides, diglycerides, and triglycerides are predominantly of C6-C12 fatty acid chain lengths. 12. The method of claim 11, wherein the monoglycerides, diglycerides, and triglycerides are >50% C6-C12 fatty acid chain lengths.