	US 12,011,503 B1
	Fixed dose oral testosterone undecanoate compositions and use thereof
Mahesh V. Patel, Salt Lake City, UT (US); Nachiappan Chidambaram, Salt Lake City, UT (US); and Kilyoung Kim, Salt Lake City, UT (US)
Filed by Lipocine Inc., Salt Lake City, UT (US)
Filed on Sep. 21, 2022, as Appl. No. 17/934,069.
Application 17/934,069 is a continuation of application No. 17/033,198, filed on Sep. 25, 2020, granted, now 11,464,735.
This patent is subject to a terminal disclaimer.
Int. Cl. C07J 1/00 (2006.01); A61K 9/00 (2006.01); A61K 31/568 (2006.01); A61P 5/26 (2006.01)

CPC A61K 9/0053 (2013.01) [A61K 31/568 (2013.01); A61P 5/26 (2018.01)]

36 Claims

1. A Testosterone Undecanoate (TU) pharmaceutical composition for restoring an effective amount of T concentration in a hypogonadal male subject in response to a predetermined dose oral administration therapy regimen thereof, wherein said composition includes a continuation criteria comprising a single serum T concentration level measured at a predetermined number of weeks after initiation of said regimen and about 8 to about 9 hours after administering a dose of said regimen, wherein if said single serum T measured concentration level is within a range of about 300 ng/dL to about 1080 ng/dL, said regimen is continued, and wherein if said single serum T concentration level is not within a range of about 300 ng/dL to about 1080 ng/dL, said regimen is discontinued.