IP Library › Granted Patent US 11,844,804
Granted Patent B2
US 11,844,804 · App. 17/157,310 · Granted Dec 19, 2023

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 11,844,804
App. No.
17/157,310
Granted
Dec 19, 2023
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 (12)

1. A method of titrating a patient to a lowest dose of testosterone while obtaining a desired blood plasma concentration of testosterone comprising:

subcutaneously administering doses of testosterone and selecting the lowest dose from 2 or more doses which provide a desired blood plasma concentration of testosterone as compared to an intramuscular dose that provides the same desired blood plasma concentration of testosterone.

2. The method of claim 1 , wherein the lowest dose is from between 50 mg., 75 mg. and 100 mg.

3. The method of claim 2 , wherein the concentration of the subcutaneously administered dose is 100 mg/ml, 150 mg/ml or 200 mg/ml.

4. The method of claim 1 , wherein the lowest dose is between 50 mg and 100 mg.

5. The method of claim 1 , wherein a prescribed time period for subcutaneously administering doses of testosterone is weekly.

6. The method of claim 5 , wherein once the desired blood plasma concentration is reached, an average blood plasma concentration obtained after administration of a subsequent dose or doses is less than + or −30% of the average plasma concentration obtained during the immediately preceding week.

7. The method of claim 1 , wherein the subcutaneously administered doses are continued after the desired blood plasma concentration is reached.

8. The method of claim 7 , wherein the subcutaneously administered doses administered after the desired blood plasma concentration is reached are the same or different than the subcutaneously administered doses administered prior to reaching the desired blood plasma concentration.

9. The method of claim 1 , wherein a desired therapeutic blood level maintained at the desired blood plasma concentration is about 800 ng/dl to about 1100 ng/dl.

10. The method of claim 1 , wherein a desired therapeutic blood level maintained at the desired blood plasma concentration is about 500 ng/dl to about 800 ng/dl.

11. The method of claim 1 , wherein a desired therapeutic blood level maintained at the desired blood plasma concentration is about 350 ng/dl to about 500 ng/dl.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 22, 2021
From: WOTTON, PAUL K.; JOOSTE, HERMANUS LAROUX; DAVE, KAUSHIK J; JAFFE, JON
To: ANTARES PHARMA, INC.
Reel/Frame 058186/0459 →
Continuity (4)
Continuation 16265531 · Feb 1, 2019
Continuation 15119344
Provisional Application 61941875 · Feb 19, 2014
Related Publication 20210137944A1 · May 13, 2021