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Last Updated: December 12, 2025

Claims for Patent: 10,639,375

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Summary for Patent: 10,639,375

Title:	Progesterone formulations
Abstract:	Various pharmaceutical formulations are disclosed herein. For example, a pharmaceutical formulation is disclosed comprising ultra-micronized progesterone.
Inventor(s):	Brian A. Bernick, Julia M. Amadio, Peter H. R. Persicaner, Janice Louise Cacace, Thorsteinn Thorsteinsson, Frederick D. Sancilio, Neda Irani
Assignee:	TherapeuticsMD Inc
Application Number:	US16/037,452
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,639,375
Patent Claims:	1. A pharmaceutical composition comprising: progesterone and an effective amount of estradiol not exceeding 2 mg, wherein the estradiol and progesterone are present in a weight ratio of 1:100; a medium chain oil; and a non-ionic surfactant; further wherein the progesterone is present from about 20 to about 50 weight percent of the composition. 2. The pharmaceutical composition of claim 1, wherein a portion of the progesterone is solubilized and a portion of the progesterone is suspended. 3. The pharmaceutical composition of claim 1, wherein the non-ionic surfactant is selected from the group consisting of lauroyl macrogol-32 glycerides EP, lauroyl polyoxyl-32 glycerides, and caprylocaproyl macrogol-8 glycerides EP. 4. The pharmaceutical composition of claim 1, wherein the composition is provided in a gelatin capsule. 5. The pharmaceutical composition of claim 1, wherein the composition provides increased progesterone bioavailability compared to a micronized progesterone suspended in peanut oil. 6. The pharmaceutical composition of claim 1, wherein the medium chain oil comprises at least one C6-C14 fatty acid mono-, di-, or tri-ester of glycerol or mono- or di-ester of a glycol. 7. The pharmaceutical composition of claim 6, wherein the at least one C6-C14 fatty acid mono-, di-, or tri-ester of glycerol is a C8 fatty acid mono-, di-, or tri-ester of glycerol. 8. The pharmaceutical composition of claim 6, further comprising a second C6-C14 fatty acid mono-, di-, or tri-ester of glycerol. 9. The pharmaceutical composition of claim 8, wherein the second C6-C14 fatty acid mono-, di-, or tri-ester of glycerol is a C10 fatty acid mono-, di-, or tri-ester of glycerol. 10. The pharmaceutical composition of claim 9, wherein the medium chain oil is CAPMUL MCM. 11. The pharmaceutical composition of claim 1, comprising 50 mg of progesterone. 12. The pharmaceutical composition of claim 1, comprising 100 mg of progesterone. 13. The pharmaceutical composition of claim 12, wherein the progesterone is ultra-micronized and has an X50 less than or equal to 15 microns. 14. The pharmaceutical composition of claim 13, wherein the ultra-micronized progesterone has an X90 of less than about 25 microns. 15. The pharmaceutical composition of claim 12, wherein a portion of the progesterone is solubilized and a portion of the progesterone is suspended. 16. The pharmaceutical composition of claim 15, wherein the non-ionic surfactant is selected from the group consisting of lauroyl macrogol-32 glycerides EP, lauroyl polyoxyl-32 glycerides, and caprylocaproyl macrogol-8 glycerides EP. 17. The pharmaceutical composition of claim 16, wherein the composition is provided in a gelatin capsule. 18. The pharmaceutical composition of claim 16, wherein the composition provides increased progesterone bioavailability compared to a micronized progesterone suspended in peanut oil. 19. The pharmaceutical composition of claim 18, wherein the medium chain oil comprises at least one C6-C14 fatty acid mono-, di-, or tri-ester of glycerol or mono- or di-ester of a glycol. 20. The pharmaceutical composition of claim 19, wherein the at least one C6-C14 fatty acid mono-, di-, or tri-ester of glycerol is a C8 fatty acid mono-, di-, or tri-ester of glycerol. 21. The pharmaceutical composition of claim 20, further comprising a second C6-C14 fatty acid mono-, di-, or tri-ester of glycerol. 22. The pharmaceutical composition of claim 21, wherein the second C6-C14 fatty acid mono-, di-, or tri-ester of glycerol is a C10 fatty acid mono-, di-, or tri-ester of glycerol. 23. The pharmaceutical composition of claim 22, wherein the medium chain oil is CAPMUL MCM.

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