US 12,133,831 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. 27, 2023, as Appl. No. 18/496,150.
Claims priority of provisional application 63/381,451, filed on Oct. 28, 2022.
Int. Cl. A61J 1/00 (2023.01); 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 containing a sterile preparation of purified corticotropin, a first needle having a first gauge size with a first diameter, and a second needle having a second gauge size with a second diameter, 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 SYSMEHFRWGKPVGKKRRPVKVYPNGAEDELALAEAFPLEF (SEQ ID NO: 1).