The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
Jun. 21, 2022

Filed:

Apr. 08, 2020
Applicant:

Lipocine Inc., Salt Lake City, UM (US);

Inventors:

Chandrashekar Giliyar, Plymouth, MN (US);

Basawaraj Chickmath, Minneapolis, MN (US);

Nachiappan Chidambaram, Sandy, UT (US);

Mahesh V. Patel, Salt Lake City, UT (US);

Srinivansan Venkateshwaran, Salt Lake City, UT (US);

Assignee:

Other;

Attorneys:
Primary Examiner:
Int. Cl.
CPC ...
A61K 31/568 (2006.01); A61K 9/00 (2006.01); A61K 9/48 (2006.01); A61K 47/12 (2006.01); A61K 47/22 (2006.01); G01N 33/74 (2006.01); A61P 15/08 (2006.01); A61K 47/44 (2017.01);
U.S. Cl.
CPC ...
A61K 31/568 (2013.01); A61K 9/0053 (2013.01); A61K 9/4858 (2013.01); A61K 9/4875 (2013.01); A61K 47/12 (2013.01); A61K 47/22 (2013.01); A61K 47/44 (2013.01); G01N 33/743 (2013.01);
Abstract

The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone Cto serum testosterone Cof about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration Crange for a male subject is provided.


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