US 12,324,787 B1
Kits for preparing and delivering purified corticotropin
Edward M. DeSimone, III, Indianapolis, IN (US); Weijun Cheng, Middleton, WI (US); and Zachary Holcomb, Waunakee, WI (US)
Assigned to ANI Pharmaceuticals, Inc., Baudette, MN (US)
Filed by ANI Pharmaceuticals, Inc., Baudette, MN (US)
Filed on Oct. 3, 2024, as Appl. No. 18/905,498.
Application 18/905,498 is a continuation of application No. 18/496,150, filed on Oct. 27, 2023, granted, now 12,133,831.
Claims priority of provisional application 63/381,451, filed on Oct. 28, 2022.
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/00 (2006.01); A61J 1/06 (2006.01); A61J 1/14 (2023.01); A61K 38/35 (2006.01); A61K 47/10 (2017.01); A61K 47/42 (2017.01)
CPC A61J 1/1443 (2013.01) [A61J 1/065 (2013.01); A61K 38/35 (2013.01); A61K 47/10 (2013.01); A61K 47/42 (2013.01)] 20 Claims
 
1. A kit comprising a vial and a sterile preparation of purified corticotropin, wherein the sterile preparation comprises 80 USP units per mL of corticotropin, phenol, type A gelatin, water for injection (WFI), hydrochloric acid, and sodium hydroxide, wherein the vial is not terminally sterilized, and
wherein the purified corticotropin comprises a polypeptide having an amino acid sequence of SYSMEHFRWGKPVGKKRRPVKVYPNGAEDELAEAFPLEF (SEQ ID NO: 1).