IP Library › Granted Patent US 12,533,328
Granted Patent B2
US 12,533,328 · App. 18/999,662 · Granted Jan 27, 2026

Epinephrine compositions and containers

Inventors: Prem Sagar Akasapu (Edison, NJ); Kumaresh Soppimath (Skillman, NJ); Reema Ajitkumar Puri (Hillsborough, NJ); Iouri V. Ilitchev (Hillsborough, NJ); Milan Patel (Edison, NJ); Pooja H. Tendulkar (East Brunswick, NJ)
Assignee: Nevakar Injectables Inc.
A61K31/137A61K9/0019A61K9/08A61K47/183
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Quick Facts
Patent No.
US 12,533,328
App. No.
18/999,662
Granted
Jan 27, 2026
Kind
B2
Abstract

A sterile storage stable ready-to-inject epinephrine composition contained within a flexible container and packaged within a secondary container, the composition including an aqueous pharmaceutically acceptable carrier containing epinephrine and a metal ion chelator, the epinephrine being present in a concentration of equal to or less than 0.07 mg/mL, substantially all of the epinephrine being an R-isomer, the composition having a pH of between 3.5-4.7, and the composition having, after storage of at least one month at 25° C., total impurities of equal or less than 0.7% and equal or less than 4% S-isomer content.

Claims (25)

1 . A sterile storage stable ready-to-inject epinephrine composition contained within a flexible container and packaged within a secondary container,

wherein the composition comprises an aqueous pharmaceutically acceptable carrier containing epinephrine and a metal ion chelator,

wherein the epinephrine is present in a concentration of equal to or less than 0.07 mg/mL,

wherein substantially all of the epinephrine is an R-isomer,

wherein the composition has a pH of between 3.5-4.7,

wherein the composition has, after storage of one month at 25° C., equal to or less than 4% S-isomer content, and

wherein at least one of the flexible container and the secondary container has an oxygen transmission rate between 0.0005 to 0.005 cc/100 in 2 /24 hrs.

2 . The composition of claim 1 , wherein the secondary container comprises an aluminum foil overwrap.

3 . The composition of claim 2 , wherein the aluminum foil overwrap comprises an oxygen scavenger.

4 . The composition of claim 1 , wherein the flexible container is a flexible infusion bag.

5 . The composition of claim 1 , wherein the flexible container has a volume of at least 100 mL.

6 . The composition of claim 1 , wherein the flexible container comprises polyethylene, polypropylene, polyethylene terephthalate, a co-polymer selected from ethylene-propylene copolymers, ethylene vinyl acetate, and copolyester ether polymers, or a combination thereof.

7 . The composition of claim 1 , wherein the epinephrine is present in a concentration of about 8 mcg/mL.

8 . The composition of claim 1 , wherein the epinephrine is present in a concentration of about 16 mcg/mL.

9 . The composition of claim 1 , wherein the epinephrine is present in a concentration of about 20 mcg/mL.

10 . The composition of claim 1 , wherein the epinephrine is present in a concentration of about 32 mcg/mL.

11 . The composition of claim 1 , wherein the epinephrine is present in a concentration of about 40 mcg/mL.

12 . The composition of claim 1 , wherein the metal ion chelator comprises disodium edetate dihydrate.

13 . The composition of claim 1 , further comprising a tonicity agent.

14 . The composition of claim 13 , wherein the tonicity agent comprises sodium chloride.

15 . The composition of claim 1 , further comprising a buffer.

16 . The composition of claim 15 , wherein the buffer comprises tartaric acid.

17 . The composition of claim 1 , further comprising a pH adjusting agent.

18 . The composition of claim 17 , wherein the pH adjusting agent comprises hydrochloric acid, sodium hydroxide, or a combination thereof.

19 . The composition of claim 1 , wherein the composition, after storage of at least one month at 25° C., changes pH no more than 0.5 pH units.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 23, 2024
From: AKASAPU, PREM SAGAR; SOPPIMATH, KUMARESH; PURI, REEMA AJITKUMAR; ILITCHEV, IOURI V.; PATEL, MILAN; TENDULKAR, POOJA H.
To: NEVAKAR, LLC
Reel/Frame 069670/0497 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 23, 2024
From: NEVAKAR INC.
To: NEVAKAR INJECTABLES INC.
Reel/Frame 069670/0604 →
CHANGE OF NAME Recorded Dec 23, 2024
From: NEVAKAR, LLC
To: NEVAKAR, INC.
Reel/Frame 069764/0798 →
Continuity (7)
Continuation 18437931 · Feb 9, 2024
Continuation 17526786 · Nov 15, 2021
Continuation 16821785 · Mar 17, 2020
Continuation 16788831 · Feb 12, 2020
Continuation 16360995 · Mar 21, 2019
Provisional Application 62647303 · Mar 23, 2018
Related Publication 20250120923A1 · Apr 17, 2025
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