Granted Patent
B2
US 12,508,238 · App. 18/437,931 · Granted Dec 30, 2025
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.
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Abstract
A ready-to-administer epinephrine composition having between about 0.005 and about 0.07 mg/mL epinephrine, at least about 0.9 wt % sodium chloride; between about 1 and about 50 ug/mL ethylenediaminetetraacetic acid; 0.005 wt % or less sodium metabisulfite, and water. Also included are systems having the composition contained in a container.
Claims (16)
1 . A pharmaceutical composition comprising:
between about 0.005 and about 0.07 mg/mL epinephrine;
at least about 0.9 wt % sodium chloride;
between about 1 and about 50 μg/mL ethylenediaminetetraacetic acid;
sodium metabisulfite at a concentration of about 0.001% to about 0.005 wt %; and
water,
wherein the pharmaceutical composition has a pH of between about 3.0 and about 5.5.
2 . The pharmaceutical composition according to claim 1 , wherein the pH is between about 3.0 and about 5.0.
3 . The pharmaceutical composition according to claim 1 , comprising about 0.016 mg/mL epinephrine.
4 . The pharmaceutical composition according to claim 1 , comprising about 0.032 mg/mL epinephrine.
5 . The pharmaceutical composition according to claim 1 , wherein the pharmaceutical composition comprises an S-isomer of epinephrine concentration of equal or less than 4% of a label claim of the epinephrine in the pharmaceutical composition after storage of at least one month at 25° C.
6 . A system comprising the pharmaceutical composition according to claim 1 contained in a container.
7 . The system of claim 6 , wherein the container comprises a polymeric material.
8 . The system of claim 7 , wherein the polymeric material comprises polypropylene, polyethylene, or a combination thereof.
9 . The system of claim 6 , wherein the container has a volume of at least about 100 mL.
10 . The system of claim 6 , wherein the container has a volume of at least about 200 mL.
Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Feb 9, 2024
From: AKASAPU, PREM SAGAR; SOPPIMATH, KUMARESH; PURI, REEMA AJITKUMAR; ILITCHEV, IOURI V.; PATEL, MILAN; TENDULKAR, POOJA H.
To: NEVAKAR, LLC
Reel/Frame 066432/0977 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Feb 9, 2024
From: NEVAKAR INC.
To: NEVAKAR INJECTABLES INC.
Reel/Frame 066433/0204 →
Continuity (6)
Provisional Application
62647303
· Mar 23, 2018
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