US 11,207,280 C1 (13,170th)
Epinephrine compositions and containers
Prem Sagar Akasapu, Edison, NJ (US); Kumaresh Soppimath, Skillman, NJ (US); Reema Ajitkumar Puri, Hillsborough, NJ (US); Iouri V. Ilitchev, Hillsborough, NJ (US); Milan Patel, Edison, NJ (US); and Pooja H. Tendulkar, East Brunswick, NJ (US)
Filed by Nevakar Injectables Inc., Bridgewater, NJ (US)
Assigned to NEVAKAR INJECTABLES INC., Bridgewater, NJ (US)
Reexamination Request No. 90/019,939, Apr. 30, 2025.
Reexamination Certificate for Patent 11,207,280, issued Dec. 28, 2021, Appl. No. 16/821,785, Mar. 17, 2020.
Application 90/019,939 is a continuation of application No. 16/788,831, filed on Feb. 12, 2020, granted, now 11,071,719.
Application 16/788,831 is a continuation of application No. 16/360,995, filed on Mar. 21, 2019, granted, now 10,653,646.
Claims priority of provisional application 62/647,303, filed on Mar. 23, 2018.
Ex Parte Reexamination Certificate issued on Jan. 30, 2026.
Int. Cl. A61K 31/137 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 47/18 (2017.01)
CPC A61K 31/137 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 47/183 (2013.01)]
AS A RESULT OF REEXAMINATION, IT HAS BEEN DETERMINED THAT:
The patentability of claims 1-3, 8 and 9 is confirmed.
Claims 4-7 and 10-20 were not reexamined.
1. A method of producing a sterile and storage stable ready-to-inject epinephrine composition, comprising:
combining an aqueous pharmaceutically acceptable carrier with epinephrine and a metal ion chelator such that the epinephrine has a concentration of equal or less than 0.07 mg/ml, wherein the metal ion chelator is present in the composition at a concentration of between about 1 and 50 ug/ml, and wherein substantially all of the epinephrine is an R-isomer;
adjusting the pH of the ready-to-inject epinephrine composition to a pH of between 3.5-4.7;
packaging the ready-to-inject epinephrine composition into a container under an inert gas; and
autoclaving the ready-to-inject epinephrine composition to sterility, wherein sterilization increases S-isomer content to no more than 4%.