Claims for Patent: 8,846,648

Summary for Patent: 8,846,648

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:	14/099,545
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,846,648
Patent Claims:	1. A method of treating a menopause-related symptom in a woman comprising: administering to the woman an effective amount of a pharmaceutical composition, the pharmaceutical composition comprising solubilized estradiol, suspended progesterone, and a 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 the solubilizing agent contains an effective amount of C6-C12 oil; and wherein at least about 90% of the estradiol is solubilized in the solubilizing agent. 2. The method of claim 1, further comprising partially solubilized progesterone, the partially solubilized progesterone being solubilized in the solubilizing agent. 3. The method of claim 1, wherein the composition is formulated as a gelatin capsule. 4. The method of claim 1, wherein the C6-C12 oil is selected from at least one of mono-, di-, and triglycerides and combinations thereof. 5. The method of claim 1, wherein the estradiol has a dosage strength of at least about 0.125 mg and wherein the progesterone has a dosage strength of at least about 25 mg. 6. The method of claim 1, wherein the ratio of progesterone to estradiol is about 24:1, about 25:1, about 96:1, about 100:1, about 192:1, or about 200:1. 7. The method of claim 1, wherein the composition is bioequivalent to a 200 mg progesterone soft gel capsule and to a 2 mg estradiol tablet. 8. A method of treating a menopause symptom in a woman comprising administering a pharmaceutical composition to the woman, the pharmaceutical composition comprising: solubilized estradiol; suspended progesterone; and a solubilizing agent, the solubilizing agent containing an effective amount of a C6-C12 oil; wherein the estradiol and the suspended progesterone are present in the solubilizing agent, the estradiol and the suspended progesterone are uniformly dispersed and at least about 90% of the estradiol is solubilized in the solubilizing agent; and wherein the estradiol does not precipitate for at least 14 days. 9. The method of claim 8, further comprising partially solubilized progesterone, the partially solubilized progesterone being solubilized in the solubilizing agent. 10. The method of claim 8, wherein the composition is formulated as a gelatin capsule. 11. The method of claim 8, wherein the C6-C12 oil is selected from at least one of mono-, di-, and triglycerides and combinations thereof. 12. The method of claim 8, wherein the estradiol has a dosage strength of at least about 0.125 mg and wherein the progesterone has a dosage strength of at least about 25 mg. 13. The method of claim 8, wherein the ratio of progesterone to estradiol is about 24:1, about 25:1, about 96:1, about 100:1, about 192:1, or about 200:1. 14. The method of claim 8, wherein the composition is bioequivalent to a 200 mg progesterone soft gel capsule and to a 2 mg estradiol tablet. 15. A method of treating a menopause symptom comprising: administering an effective amount of a pharmaceutical composition to a woman, the pharmaceutical composition comprising solubilized estradiol, suspended progesterone, and a solubilizing agent, the estradiol being stable in the solubilizing agent for at least 14 days; 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 agnent, and wherein the solubilizing agent contains an effective amount of a C6-C12 oil. 16. The method of claim 15, further comprising partially solubilized progesterone, the partially solubilized progesterone being solubilized in the solubilizing agent. 17. The method of claim 15, wherein the composition is formulated as a gelatin capsule. 18. The method of claim 15, wherein the C6-C12 oil is selected from at least one of mono-, di-, and triglycerides and combinations thereof. 19. The method of claim 15, wherein the estradiol has a dosage strength of at least about 0.125 mg and wherein the progesterone has a dosage strength of at least about 25 mg. 20. The method of claim 15, wherein the ratio of progesterone to estradiol is about 24:1, about 25:1, about 96:1, about 100:1, about 192:1, or about 200:1.