Claims for Patent: 11,602,508

Summary for Patent: 11,602,508

Title:	Norepinephrine compositions and methods therefor
Abstract:	The inventive subject matter is directed to compositions and methods for ready-to-inject norepinephrine compositions with improved stability. Most preferably, compositions presented herein are substantially antioxidant free and exhibit less than 10% isomerization of R-norepinephrine and exhibit less than 5% degradation of total norepinephrine.
Inventor(s):	Tushar Hingorani, Kumaresh Soppimath
Assignee:	Nevakar Injectables Inc
Application Number:	US17/872,450
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,602,508
Patent Claims:	1. A ready-to-administer norepinephrine composition, comprising: an aqueous solution having a pH range of between 3.7 and 4.3, wherein the aqueous solution comprises: norepinephrine present at a concentration of between 10 μg/ml and 100 μg/ml, wherein the norepinephrine initially comprises at least 95% of R-isomer as determined by HPLC; a chelating agent comprising a tartrate bicarboxylic acid, wherein the chelating agent is present at a concentration of between 10 μg/ml and 100 μg/ml; and a tonicity agent, wherein the ready-to-administer norepinephrine composition is substantially free of antioxidants; and wherein after storage at 25±2° C. and 60±5% relative humidity over at least three months, the norepinephrine comprises at least 90% R-isomer as determined by HPLC. 2. The composition of claim 1, wherein the tonicity agent is present in an amount to obtain osmolality of the solution of between 260 mOsm/kg and 340 mOsm/kg. 3. The composition of claim 1, wherein the tonicity agent comprises a pharmaceutically acceptable salt and is present in an amount of between 0.6 wt % and 1.2 wt %. 4. The composition of claim 1, wherein the tonicity agent comprises dextrose. 5. The composition of claim 1, wherein the tonicity agent comprises NaCl. 6. The composition of claim 1, wherein the composition is sterile. 7. The composition of claim 1, wherein the norepinephrine comprises one or more of norepinephrine acid, norepinephrine mineral salt and norepinephrine organic salt. 8. The composition of claim 1, wherein the norepinephrine comprises a norepinephrine organic salt. 9. The composition of claim 1, wherein the composition is free of added buffer. 10. The composition of claim 1, wherein the chelating agent further comprises an aminopolycarboxylic acid.