US 12,440,459 B2
Norepinephrine compositions and methods therefor
Harshil H. Jain, Monmouth Junction, NJ (US); Tushar Hingorani, Bridgewater, NJ (US); and Kumaresh Soppimath, Skillman, NJ (US)
Assigned to NEVAKAR INJECTABLES INC., Bridgewater, NJ (US)
Filed by Nevakar Injectables Inc., Bridgewater, NJ (US)
Filed on Feb. 14, 2025, as Appl. No. 19/054,330.
Application 17/861,752 is a division of application No. 16/839,450, filed on Apr. 3, 2020, granted, now 11,413,259, issued on Aug. 16, 2022.
Application 16/839,450 is a division of application No. 16/239,465, filed on Jan. 3, 2019, granted, now 10,646,458, issued on May 12, 2020.
Application 16/239,465 is a division of application No. 15/883,798, filed on Jan. 30, 2018, granted, now 10,226,436, issued on Mar. 12, 2019.
Application 19/054,330 is a continuation of application No. 19/043,163, filed on Jan. 31, 2025.
Application 19/043,163 is a continuation in part of application No. 17/861,752, filed on Jul. 11, 2022, granted, now 12,245,996.
Claims priority of provisional application 62/452,220, filed on Jan. 30, 2017.
Prior Publication US 2025/0186370 A1, Jun. 12, 2025
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/137 (2006.01); A61K 9/00 (2006.01); A61K 47/12 (2006.01); A61K 47/18 (2017.01); A61P 9/02 (2006.01)
CPC A61K 31/137 (2013.01) [A61K 9/0019 (2013.01); A61K 47/12 (2013.01); A61K 47/183 (2013.01); A61P 9/02 (2018.01)] 20 Claims
 
1. A sterile and ready to ready-to-administer norepinephrine composition, comprising:
an aqueous acidic solution having a pH range of between 3.8 and 4.1, wherein the aqueous solution further comprises a chelating agent, and a pharmaceutically acceptable salt or tonicity agent;
wherein the ready-to-administer norepinephrine composition is substantially free of antioxidants;
norepinephrine or salt thereof, dissolved in the composition at a norepinephrine concentration of between about 16 μg/ml (+/−10%) and 128 μg/ml (+/−10%), wherein the norepinephrine is an R-isomer of norepinephrine; and
wherein the ready-to-administer norepinephrine composition is formulated such that after terminal sterilization and storage over at least three months at 25° C. equal or less than 10% of the R-isomer form will isomerize to the S-isomer and such that no more than 0.5% total impurities are formed.