Claims for Patent: 12,011,503

Summary for Patent: 12,011,503

Title:	Fixed dose oral testosterone undecanoate compositions and use thereof
Abstract:	Disclosed are effective fixed dose oral testosterone undecanoate compositions for use in regimens without dose titration and methods for treatment of patients in need of testosterone replacement therapy. Also disclosed are criteria for continuation and discontinuation of such regimens, based on single serum T concentration levels measured at a steady state at predetermined times after initiation of said regimen and at a predetermined number of hours after administration of a morning dose of the regimen.
Inventor(s):	Mahesh V. Patel, Nachiappan Chidambaram, Kilyoung Kim
Assignee:	Lipocine Inc
Application Number:	US17/934,069
Patent 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. 2. The composition of claim 1, wherein said predetermined number of weeks comprises about 3 to about 4 weeks, and wherein said about 8 to about 9 hours after administering a dose of said regimen comprises about 8 to about 9 hours after administering a morning dose of said regimen. 3. The composition of claim 1, wherein said regimen comprises at least one of a daily administration of about 450 mg of TU and a twice daily administration of about 225 mg of TU. 4. The composition of claim 3, wherein said about 225 mg of TU comprises two capsules, and wherein each capsule comprises about 112.5 mg of TU. 5. The composition of claim 1, wherein said regimen comprises at least one of an administration of said composition with food regimen and an untitrated dose regimen. 6. The composition of claim 1, wherein said subject has a testosterone concentration below at least one of 300 ng/dL, 250 ng/dL, 200 ng/dL, 150 ng/dL, and 100 ng/dL, and wherein in response to said regimen, a T Cavg of said subject is increased. 7. The composition of claim 6, wherein said increase of said T Cavg comprises a minimum increase of at least one of 30 ng/dL, 50 ng/dL, 75 ng/dL, 100 ng/dL, 150 ng/dL, 200 ng/dL, 300 ng/dL, 400 ng/dL, 500 ng/dL, 600 ng/dL, 700 ng/dL, 800 ng/dL and greater than 800 ng/dL. 8. The composition of claim 1, wherein said composition has a responder rate of at least 75%. 9. The composition of claim 1, wherein said single serum T concentration level measured at a steady state comprises a periodic single serum T concentration level measured at a steady state. 10. 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 the monitoring of a single serum T concentration level measured at a predetermined number of weeks after initiating said regimen and at least six hours after administering a morning dose of said regimen, wherein if said measured serum T concentration level is within the range of about 300 ng/dL to about 1080 ng/dL, said regiment is continued, and wherein if said measured serum T concentration level is less than about 300 ng/dL, said regiment is discontinued, and wherein if said measured serum T concentration level is greater than about 1080 ng/dL, said regiment is discontinued. 11. The composition of claim 10, wherein predetermined number of weeks comprises about 3 to about 4 weeks, and wherein said at least six hours comprises about 8 to about 9 hours. 12. The composition of claim 11, wherein said regimen comprises at least one of a daily administration of about 450 mg of TU and a twice daily administration of about 225 mg of TU. 13. The composition of claim 12, wherein said about 225 mg of TU comprises two capsules, and wherein each capsule comprises about 112.5 mg of TU. 14. The composition of claim 10, wherein said regimen comprises at least one of an administration of said composition with food regimen and an untitrated dose regimen. 15. The composition of claim 10, wherein said subject has a testosterone concentration below at least one of 300 ng/dL, 250 ng/dL, 200 ng/dL, 150 ng/dL, and 100 ng/dL, and wherein in response to said regimen, a T Cavg of said subject is increased. 16. The composition of claim 15, wherein said increase of said T Cavg comprises a minimum increase of at least one of 30 ng/dL, 50 ng/dL, 75 ng/dL, 100 ng/dL, 150 ng/dL, 200 ng/dL, 300 ng/dL, 400 ng/dL, 500 ng/dL, 600 ng/dL, 700 ng/dL, 800 ng/dL and greater than 800 ng/dL. 17. The composition of claim 10, wherein said composition has a responder rate of at least 75%. 18. A method of continuing or discontinuing a predetermined dose oral administration regimen of a TU pharmaceutical composition comprising: initiating said regimen to a hypogonadal male subject having a testosterone concentration below 300 ng/dL; measuring a steady state single serum T concentration level 8 to 9 hours after administration of a dose of said regimen a predetermined number of weeks after initiation of said regimen; and continuing said regimen if said measurement is within a range of about 300 ng/dL to about 1,080 ng/dL and discontinuing said regimen if said measurement is not within a range of about 300 ng/dL to about 1,080 ng/dL. 19. The method of claim 18, wherein said predetermined number of weeks comprises about 3 to about 4 weeks, and wherein said about 8 to about 9 hours after administering a dose of said regimen comprises about 8 to about 9 hours after administering a morning dose of said regimen. 20. The method of claim 19, wherein said regimen comprises at least one of a daily administration of about 450 mg of TU and a twice daily administration of about 225 mg of TU. 21. The method of claim 20, wherein said about 225 mg of TU comprises two capsules, and wherein each capsule comprises about 112.5 mg of TU. 22. The method of claim 18, wherein said regimen comprises at least one of an administration of said composition with food regimen and an untitrated dose regimen. 23. The method of claim 18, wherein in response to said regimen, a T Cavg of said subject is increased. 24. The method of claim 23, wherein said increase of said T Cavg comprises a minimum increase of at least one of 30 ng/dL, 50 ng/dL, 75 ng/dL, 100 ng/dL, 150 ng/dL, 200 ng/dL, 300 ng/dL, 400 ng/dL, 500 ng/dL, 600 ng/dL, 700 ng/dL, 800 ng/dL and greater than 800 ng/dL. 25. The method of claim 18, wherein said method has a responder rate of at least 75%. 26. The method of claim 18, wherein said measuring step comprises a periodic measuring step. 27. A method of continuing or discontinuing a predetermined dose oral administration regimen of a TU pharmaceutical composition comprising: initiating said regimen to a hypogonadal male subject having a testosterone concentration below 300 ng/dL; measuring a steady state single serum T concentration level at least six hours after administration of a morning dose of said regimen a predetermined number of weeks after initiation of said regimen; and continuing said regimen if said measurement is within a range of about 300 ng/dL to about 1,080 ng/dL. 28. The method of claim 27, wherein said predetermined number of weeks comprises about 3 to about 4 weeks, and wherein said at least six hours comprises about 8 to about 9 hours. 29. The method of claim 28, wherein said regimen comprises at least one of a daily administration of about 450 mg of TU and a twice daily administration of about 225 mg of TU. 30. The method of claim 29, wherein said about 225 mg of TU comprises two capsules, and wherein each capsule comprises about 112.5 mg of TU. 31. The method of claim 27, wherein said regimen comprises at least one of an administration of said composition with food regimen and an untitrated dose regimen. 32. The method of claim 27, wherein in response to said regimen, a T Cavg of said subject is increased. 33. The method of claim 32, wherein said increase of said T Cavg comprises a minimum increase of at least one of 30 ng/dL, 50 ng/dL, 75 ng/dL, 100 ng/dL, 150 ng/dL, 200 ng/dL, 300 ng/dL, 400 ng/dL, 500 ng/dL, 600 ng/dL, 700 ng/dL, 800 ng/dL and greater than 800 ng/dL. 34. The method of claim 27, wherein said method has a responder rate of at least 75%. 35. The method of claim 27, wherein said measuring step comprises a periodic measuring step. 36. The method of claim 27, wherein said method includes the step of discontinuing said regimen if said measurement is not within a range of about 300 ng/dL to about 1,080 ng/dL.