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Last Updated: March 29, 2024

Claims for Patent: 8,778,916


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Summary for Patent: 8,778,916
Title:Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Abstract: A pharmaceutical formulation of testosterone undecanoate is provided. Methods of treating a testosterone deficiency or its symptoms with the inventive formulations are also provided.
Inventor(s): Dudley; Robert E. (Rosemary Beach, FL), Constantinides; Panayiotis P. (Gurnee, IL)
Assignee: Clarus Therapeutics, Inc. (Northbrook, IL)
Application Number:13/584,958
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,778,916
Patent Claims: 1. An oral pharmaceutical composition comprising: a. 18-22 percent by weight of solubilized testosterone undecanoate; b. 50-55 percent by weight of at least one lipophilic surfactant; and; c. 15-17 percent by weight of at least one hydrophilic surfactant; d. 10-15 percent by weight of a mixture of 5-.alpha. reductase inhibitor and P450 isozyme CYP3A4 inhibitor.

2. The composition as recited in claim 1 wherein said hydrophilic surfactant is polyoxyethylene(40)hydrogenated castor oil.

3. The composition as recited in claim 1 wherein said lipophilic surfactant is oleic acid.

4. The composition as recited in claim 1 wherein said 5-.alpha. reductase inhibitor is borage seed oil.

5. The composition as recited in claim 1 wherein said P450 isozyme CYP3A4 inhibitor is peppermint oil.

6. An oral pharmaceutical composition comprising: a. 19.8 percent by weight of solubilized testosterone undecanoate; b. 51.6 percent by weight of oleic acid; c. 16.1 percent by weight of polyoxyethylene(40)hydrogenated castor oil; d. 10 percent by weight of 5-.alpha. reductase inhibitor; e. 2.5 percent by weight of P450 isozyme CYP3A4 inhibitor; and f. 0.03 percent by weight of butylhydroxytoluene (BHT).

7. The composition as recited in claim 6 wherein said 5-.alpha. reductase inhibitor is borage seed oil.

8. The composition as recited in claim 6 wherein said P450 isozyme CYP3A4 inhibitor is peppermint oil.

9. The composition as recited in claim 1, wherein upon once- or twice-daily oral administration, provides an average serum testosterone concentration at steady state falling in the range of about 300 to about 1100 ng/dL.

10. The composition as recited in claim 1, wherein the ratio of lipophilic surfactants to hydrophilic surfactants is about 4:1.

11. The composition as recited in either of claims 1 or 6, wherein said testosterone undecanoate is dissolved in solution above 30.degree. C.

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