You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 7, 2024

Claims for Patent: 8,633,178

✉ Email this page to a colleague

« Back to Dashboard

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.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.