Claims for Patent: 10,821,072

Summary for Patent: 10,821,072

Title:	Needle assisted jet 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), Dave; Kaushik J. (Edison, NJ), Hayes; John W. (Chaska, MN), Sadowski; Peter L. (Woodbury, MN), Jooste; Hermanus L. (Wayne, PA), Jaffe; Jonathan (Annandale, NJ)
Assignee:	Antares Pharma, Inc. (Ewing, NJ)
Application Number:	16/149,032
Patent Claims:	1. A method of administering testosterone comprising: subcutaneously administering a preservative-free composition comprising a unit dose of testosterone or a pharmaceutically acceptable ester or salt thereof in a pharmaceutically acceptable carrier to a mammal, wherein a plasma level of testosterone remains above about 200 ng/dl for a predetermined period of time after administration, and wherein administering the preservative-free composition comprises at least one injection via a powered injector comprising a housing, a chamber disposed within the housing, the chamber configured to receive the preservative-free composition, and a needle operatively associated with the chamber. 2. The method of claim 1, wherein the at least one injection consists of two injections. 3. The method of claim 1, wherein the at least one injection consists of three injections. 4. The method of claim 1, wherein the at least one injection consists of more than three injections. 5. The method of claim 1, wherein the plasma level of testosterone remains above a value selected from the group consisting of about 300 ng/dl, about 350 ng/dl, about 400 ng/dl, about 450 ng/dl, about 500 ng/dl, about 550 ng/dl, about 600 ng/dl, about 650 ng/dl, about 700 ng/dl, about 750 ng/dl, about 800 ng/dl, about 850 ng/dl, about 900 ng/dl, about 950 ng/dl, about 1000 ng/dl, about 1050 ng/dl, and about 1100 ng/dl for the predetermined period of time. 6. The method of claim 1, wherein the predetermined period of time is at least 1 hour. 7. The method of claim 1, wherein the predetermined period of time is at least 12 hours. 8. The method of claim 1, wherein the predetermined period of time period is at least 1 day. 9. The method of claim 1, wherein the predetermined period of time is at least 6 days. 10. The method of claim 1, wherein the predetermined period of time is at least 7 days. 11. The method of claim 1, wherein the predetermined period of time is at least 9 days. 12. The method of claim 1, wherein the predetermined period of time is at least 11 days. 13. The method of claim 1, wherein the predetermined period of time is at least 13 days. 14. The method of claim 1, wherein the predetermined period of time is at least 15 days. 15. The method of claim 1, wherein the predetermined period of time is at least 20 days. 16. The method of claim 1, wherein the predetermined period of time is at least 25 days. 17. The method of claim 1, wherein the preservative-free composition comprises a liquid composition. 18. The method of claim 1, wherein the administering of the preservative-free composition includes administering a single unit dose. 19. The method of claim 1, wherein the plasma level of testosterone does not exceed about 1800 ng/dl for the predetermined period of time after administration. 20. The method of claim 1, wherein the preservative-free composition is substantially free of precipitate.