	US 12,233,105 B1
	Methods for storing and warming purified corticotropin compositions
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 Aug. 29, 2024, as Appl. No. 18/818,974.
Application 18/818,974 is a continuation of application No. 18/634,717, filed on Apr. 12, 2024, granted, now 12,102,662.
Application 18/634,717 is a continuation of application No. 18/495,932, filed on Oct. 27, 2023, granted, now 11,975,047, issued on May 7, 2024.
Claims priority of provisional application 63/381,451, filed on Oct. 28, 2022.
This patent is subject to a terminal disclaimer.
Int. Cl. A61J 1/20 (2006.01); A61J 1/14 (2023.01); A61K 38/22 (2006.01); A61K 47/10 (2017.01); A61K 47/42 (2017.01); B65D 39/00 (2006.01)

CPC A61K 38/2228 (2013.01) [A61J 1/1412 (2013.01); A61J 1/1468 (2015.05); A61J 1/20 (2013.01); A61K 38/22 (2013.01); A61K 47/10 (2013.01); A61K 47/42 (2013.01); B65D 39/00 (2013.01); A61J 2200/42 (2013.01)]

30 Claims

1. A method comprising:

a) storing a sterile corticotropin composition at a temperature of 2° to 8° C.;

b) warming the sterile corticotropin composition to a temperature of 18° to 26° C.;

c) injecting 80 United States Pharmacopeia (USP) units of the sterile corticotropin composition into a human subject after step b),

wherein the corticotropin comprises amino acids 1-39 of SEQ ID NO: 1, or

wherein the sterile corticotropin composition has not more than 0.05 USP Vasopressin Units/USP Corticotropin Units, or

wherein the sterile corticotropin composition comprises acidified WFI having a pH of 2.8 to 3.2.