US 12,280,024 B2
Epinephrine formulations
Suketu Sanghvi, Kendall Park, NJ (US); Vinayagam Kannan, Morris Plains, NJ (US); and Matthew Kenney, New Haven, MI (US)
Assigned to ENDO OPERATIONS LIMITED, Dublin (IE)
Filed by Par Pharmaceutical, Inc., Chestnut Ridge, NY (US)
Filed on Sep. 28, 2023, as Appl. No. 18/477,161.
Application 18/477,161 is a continuation of application No. 17/685,090, filed on Mar. 2, 2022.
Application 17/685,090 is a continuation of application No. 16/817,253, filed on Mar. 12, 2020, granted, now 11,337,938, issued on May 24, 2022.
Application 16/817,253 is a continuation of application No. 16/258,204, filed on Jan. 25, 2019, granted, now 10,624,864, issued on Apr. 21, 2020.
Application 16/258,204 is a continuation of application No. 15/969,500, filed on May 2, 2018, abandoned.
Application 15/969,500 is a continuation of application No. 15/455,991, filed on Mar. 10, 2017, abandoned.
Application 15/455,991 is a continuation in part of application No. 14/863,112, filed on Sep. 23, 2015, granted, now 10,130,592, issued on Nov. 20, 2018.
Application 14/863,112 is a continuation of application No. 14/818,121, filed on Aug. 4, 2015, granted, now 9,295,657, issued on Mar. 29, 2016.
Application 14/818,121 is a continuation of application No. 14/657,990, filed on Mar. 13, 2015, granted, now 9,119,876, issued on Sep. 1, 2015.
Prior Publication US 2024/0058281 A1, Feb. 22, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/137 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 47/12 (2006.01); A61K 47/20 (2006.01)
CPC A61K 31/137 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 47/12 (2013.01); A61K 47/20 (2013.01); A61K 9/0014 (2013.01); A61K 9/0048 (2013.01); A61K 9/0073 (2013.01)] 4 Claims
OG exemplary drawing
 
1. A composition comprising:
in the range of about 0.75 to 1.25 mg/mL of epinephrine and/or salts thereof,
in the range of about 6 to 8 mg/mL of a tonicity regulating agent,
in the range of 2 and 15 mg/mL of tartaric acid,
in the range of 1 and 5 mg/mL of sodium hydroxide,
in the range of about 0.4 and 0.5 mg/mL of an antioxidant,
in the range of about 0.001 to 0.010 mL/mL of a pH lowering agent,
wherein the antioxidant comprises sodium bisulfite and/or sodium metabisulfite, and
wherein the composition comprises about 3% or less total impurities after 6 months of storage at between 23° C. and 32° C. and between 55% RH and 70% RH.