	US 12,115,164 B2
	Pemetrexed formulations
Feng-Jing Chen, Irvine, CA (US); and Steven L. Krill, Midland Park, NJ (US)
Assigned to Eagle Pharmaceuticals, Inc., Woodcliff Lake, NJ (US)
Filed by Eagle Pharmaceuticals, Inc., Woodcliff Lake, NJ (US)
Filed on Sep. 20, 2023, as Appl. No. 18/470,952.
Application 18/470,952 is a division of application No. 17/835,236, filed on Jun. 8, 2022, granted, now 11,793,813.
Application 17/835,236 is a continuation of application No. 16/297,125, filed on Mar. 8, 2019.
Application 16/297,125 is a continuation of application No. 15/828,858, filed on Dec. 1, 2017, abandoned.
Application 15/828,858 is a continuation of application No. 15/048,416, filed on Feb. 19, 2016, abandoned.
Prior Publication US 2024/0009199 A1, Jan. 11, 2024
Int. Cl. A61K 31/519 (2006.01); A61K 9/00 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01)

CPC A61K 31/519 (2013.01) [A61K 9/0019 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01)]

15 Claims

1. A method of treating pleural mesothelioma or non-squamous, non-small cell lung cancer in a patient in need thereof comprising

providing a liquid pharmaceutical composition consisting of:

20 mg/mL to 30 mg/mL of pemetrexed diacid;

200 mg/mL to 300 mg/mL of propylene glycol;

12 mg/mL to 24 mg/mL of tromethamine;

optionally HCl; and

water,

wherein the pH of the composition is from about 7.4 to 7.6, wherein the composition is suitable for multi-dose administration, and wherein the composition remains stable when stored for about 14 months at a temperature of 2° ° C. to 8° C. in a container having a head-space oxygen content of about 20% v/v, such that the composition comprises no more than 3% w/w of total impurities after said storage;

diluting the liquid composition with normal saline, water for injection, 5% dextrose in water, Ringer's Injection, or Lactated Ringer's Injection to form a diluted liquid composition; and

intravenously administering the diluted liquid composition to the patient.