IP Library › Granted Patent US 12,605,391
Granted Patent B2
US 12,605,391 · App. 18/086,994 · Granted Apr 21, 2026

Methods of treating testosterone deficiency

Inventors: Robert E. Dudley (Murfreesboro, TN); Theodore Danoff (Philadelphia, PA); James A. Longstreth (Fort Collins, CO)
Assignee: Tolmar, Inc.
A61K31/568A61K9/0053
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Quick Facts
Patent No.
US 12,605,391
App. No.
18/086,994
Granted
Apr 21, 2026
Kind
B2
Abstract

Methods of treating a testosterone deficiency or its symptoms with a pharmaceutical formulation of testosterone esters are provided. In some embodiments, the subject has adequately controlled blood pressure.

Claims (23)

1 . A method of treating one or more conditions associated with a deficiency or absence of endogenous testosterone in a subject, comprising:

administering a defined dose of testosterone undecanoate to the subject in an oral pharmaceutical composition twice daily, once in the morning and once in the evening, wherein the defined dose is selected from 158 mg, 198 mg, 237 mg, 316 mg, and 396 mg of testosterone undecanoate; and

monitoring the subject's blood pressure after administration of the defined dose;

wherein:

the subject has adequately controlled blood pressure-at the time the oral pharmaceutical composition is first administered; and

the oral pharmaceutical composition comprises the testosterone undecanoate solubilized in a carrier comprising at least one hydrophilic surfactant and at least one lipophilic surfactant.

2 . The method of claim 1 , wherein the subject is not being treated with antihypertensive therapy.

3 . The method of claim 1 , wherein the subject is being treated with antihypertensive therapy.

4 . The method of claim 1 , further comprising treating the subject for new-onset hypertension or exacerbation of pre-existing hypertension.

5 . The method of claim 1 , further comprising, prior to administration of the pharmaceutical composition, informing the subject that administration of the pharmaceutical composition may result in an increase in blood pressure.

6 . The method of claim 1 , wherein administration of the oral pharmaceutical composition results in an average increase of systolic blood pressure of 4.9 mm Hg based on ambulatory blood pressure monitoring.

7 . The method of claim 1 , further comprising, prior to administration of the pharmaceutical composition, informing the subject that co-administration of the oral pharmaceutical composition with a prescription medication known to increase blood pressure and/or a nonprescription analgesic and/or a cold medication may result in additional increases in blood pressure.

8 . The method of claim 1 , further comprising monitoring the subject for new-onset hypertension or exacerbation of pre-existing hypertension.

9 . The method of claim 1 , wherein the subject has one or more cardiovascular risk factors or established cardiovascular disease.

10 . The method of claim 1 , wherein the defined dose is 237 mg.

11 . The method of claim 1 , wherein the subject is diagnosed with primary hypogonadism.

12 . The method of claim 1 , wherein the subject is diagnosed with hypogonadotropic hypogonadism.

13 . The method of claim 1 , wherein the lipophilic surfactant is a fatty acid.

14 . The method of claim 1 , wherein the hydrophilic surfactant is a hydrogenated castor oil ethoxylate.

15 . The method of claim 1 , wherein the oral pharmaceutical composition further comprises a digestible oil.

16 . The method of claim 1 , wherein the oral pharmaceutical composition comprises about 18-22% (w/w) testosterone undecanoate.

17 . The method of claim 1 , wherein the ratio (w/w) in the composition of total lipophilic surfactant to total hydrophilic surfactant is in the range of about 6:1 to about 3.5:1.

18 . The method of claim 1 , wherein the lipophilic surfactant is oleic acid and the hydrophilic surfactant is a hydrogenated castor oil ethoxylate.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 4, 2024
From: LONGSTRETH, JAMES A.
To: TOLMAR, INC.
Reel/Frame 068792/0480 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 20, 2023
From: CLARUS THERAPEUTICS, INC.
To: TOLMAR, INC.
Reel/Frame 063030/0634 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 20, 2023
From: DUDLEY, ROBERT E.; DANOFF, THEODORE
To: CLARUS THERAPEUTICS, INC.
Reel/Frame 063117/0960 →
Continuity (2)
Continuation 16382835 · Apr 12, 2019
Related Publication 20230218635A1 · Jul 13, 2023
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