	US 12,440,542 B1
	Kits for preparing and delivering purified corticotropin
Edward M. DeSimone, III, Indianapolis, MN (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 May 6, 2025, as Appl. No. 19/199,523.
Application 19/199,523 is a continuation of application No. 18/905,498, filed on Oct. 3, 2024, granted, now 12,324,787.
Application 18/905,498 is a continuation of application No. 18/496,150, filed on Oct. 27, 2023, granted, now 12,133,831, issued on Nov. 5, 2024.
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); A61J 1/20 (2006.01); A61K 38/22 (2006.01); A61K 38/35 (2006.01); A61K 47/10 (2017.01); A61K 47/42 (2017.01); B65D 39/00 (2006.01)

CPC A61K 38/2228 (2013.01) [A61J 1/065 (2013.01); A61J 1/1412 (2013.01); A61J 1/1443 (2013.01); A61J 1/1468 (2015.05); A61J 1/20 (2013.01); A61K 38/22 (2013.01); A61K 38/35 (2013.01); A61K 47/10 (2013.01); A61K 47/42 (2013.01); B65D 39/00 (2013.01); A61J 2200/42 (2013.01)]

20 Claims

1. A syringe containing a sterile preparation of purified corticotropin, wherein the sterile preparation comprises 80 USP units per mL of the purified corticotropin, phenol, type A gelatin, water for injection (WFI), hydrochloric acid, and sodium hydroxide, and

wherein the purified corticotropin comprises a polypeptide having an amino acid sequence of

	(SEQ ID NO: 1)
	SYSMEHFRWGKPVGKKRRPVKVYPNGAEDELAEAFPLEF.