Claims for Patent: 10,912,782

Summary for Patent: 10,912,782

Title:	Needle assisted injection administration of testosterone compositions
Abstract:	The present invention provides compositions and methods for treating a subject in need of treatment with testosterone, including introducing testosterone into the subject subcutaneously, intradermally, or intramuscularly, from a needle assisted jet injection device.
Inventor(s):	Wotton; Paul K. (Newtown, PA), Jooste; Hermanus L. (Wayne, PA), Dave; Kaushik J. (Edison, NJ), Jaffe; Jonathan (Annandale, NJ)
Assignee:	Antares Pharma, Inc. (Ewing, NJ)
Application Number:	16/265,531
Patent Claims:	1. A method of obtaining steady state average blood concentration of testosterone comprising: the step of repeatedly administering a dose of testosterone over a prescribed time period such that a steady state blood plasma level of testosterone is obtained after three or more doses, wherein once steady state is reached, the average blood plasma concentration obtained after administration of a subsequent dose or doses is less than + or -30% of the average plasma concentration obtained after an immediately preceding dose. 2. The method of claim 1, wherein the dose is selected from between 50 mg, 75 mg and 100 mg. 3. The method of claim 2, wherein the concentration of the administered dose is 100 mg/ml, 150 mg/ml or 200 mg/ml. 4. The method of claim 1, wherein the dose is between 50 mg and 100 mg. 5. The method of claim 1, wherein the prescribed time period is weekly dosing. 6. The method of claim 1, wherein steady state is reached after the fourth dose. 7. The method of claim 1, wherein steady state is reached after the fifth dose. 8. The method of claim 1, wherein the doses are continued after steady state is reached. 9. The method of claim 8, wherein the doses administered after steady state is reached are the same or different than the dose administered prior to reaching steady state. 10. The method of claim 1, wherein the steady state therapeutic blood levels maintained at steady state after multiple dosings is about 800 ng/dl to about 1100 ng/dl. 11. The method of claim 1, wherein the steady state therapeutic blood levels maintained at steady state after multiple dosings is about 500 ng/dl to about 800 ng/dl. 12. The method of claim 1, wherein the steady state therapeutic blood levels maintained at steady state after multiple dosings is about 350 ng/dl to about 500 ng/dl. 13. The method of claim 1, wherein the dose of testosterone comprises a liquid. 14. The method of claim 1, wherein repeatedly administering the dose of testosterone includes injecting the dose of testosterone.