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Last Updated: November 22, 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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