US 12,138,271 B2
Pharmaceutical compositions of testosterone
Umangi K. Soni, Telangana (IN); Prem Prakash Singh, Telangana (IN); Hanimi Reddy Bapatu, Telangana (IN); Praveen Kumar Subbappa, Princeton, NJ (US); and Ajay Kumar Singh, Princeton, NJ (US)
Assigned to SLAYBACK PHARMA LLC, Princeton, NJ (US)
Filed by SLAYBACK PHARMA LLC, Princeton, NJ (US)
Filed on Apr. 12, 2023, as Appl. No. 18/299,493.
Application 18/299,493 is a continuation of application No. 17/696,319, filed on Mar. 16, 2022, granted, now 11,642,355.
Application 17/696,319 is a continuation of application No. 16/363,376, filed on Mar. 25, 2019, granted, now 11,311,554, issued on Apr. 26, 2022.
Claims priority of application No. 201841012805 (IN), filed on Apr. 4, 2018.
Prior Publication US 2023/0248742 A1, Aug. 10, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/568 (2006.01); A61K 9/00 (2006.01); A61K 47/06 (2006.01); A61P 5/26 (2006.01)
CPC A61K 31/568 (2013.01) [A61K 9/0019 (2013.01); A61K 47/06 (2013.01); A61P 5/26 (2018.01)] 16 Claims
 
1. An injectable pharmaceutical composition comprising:
a. about 200 mg/mL testosterone cypionate;
b. about 15 mg/mL to 30 mg/mL benzyl alcohol;
c. benzyl benzoate; and
d. cotton seed oil;
wherein the testosterone cypionate is the only hormonally active ingredient in the pharmaceutical composition and present in a therapeutically effective amount;
wherein the composition is sterilized and suitable for intramuscular injection; and
wherein the composition does not exhibit crystal formation for 6 months when stored at a temperature of about 10° C. to about 15° C.