IP Library › Granted Patent US 10,912,782
Granted Patent B2
US 10,912,782 · App. 16/265,531 · Granted Feb 9, 2021

Needle assisted injection administration of testosterone compositions

Inventors: Paul K. Wotton (Newtown, PA); Hermanus L. Jooste (Wayne, PA); Kaushik J. Dave (Edison, NJ); Jonathan Jaffe (Annandale, NJ)
Assignee: Antares Pharma, Inc.
A61K31/568A61K9/0019A61K9/0021A61K9/08A61K9/10A61K47/10A61K47/44A61M5/2033A61M5/30A61M5/3204A61M2005/206A61M2005/2013A61M2005/2073A61P5/26
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Quick Facts
Patent No.
US 10,912,782
App. No.
16/265,531
Granted
Feb 9, 2021
Kind
B2
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.

Claims (16)

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.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 2, 2022
From: WOTTON, PAUL K.; JOOSTE, HERMANUS L.; DAVE, KAUSHIK J.; JAFFE, JONATHAN
To: ANTARES PHARMA, INC.
Reel/Frame 059479/0623 →
Continuity (3)
Continuation 15119344
Provisional Application 61941875 · Feb 19, 2014
Related Publication 20190224215A1 · Jul 25, 2019
Cited By (1)
US 12,527,802