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Last Updated: December 12, 2025

Claims for Patent: 12,280,024


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Summary for Patent: 12,280,024
Title:Epinephrine formulations
Abstract:Pharmaceutical compositions comprising epinephrine, methods of administration, and methods of making the same. Compositions may comprise at least one of an active agent, a pH raising agent, an antioxidant, a transition metal complexing agent, a pH lowering agent, a tonicity regulating agent, optionally a preservative, and optionally a solvent.
Inventor(s):Suketu Sanghvi, Vinayagam Kannan, Matthew Kenney
Assignee: Endo Operations Ltd
Application Number:US18/477,161
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,280,024
Patent Claims: 1. A composition comprising: in the range of about 0.75 to 1.25 mg/mL of epinephrine and/or salts thereof, in the range of about 6 to 8 mg/mL of a tonicity regulating agent, in the range of 2 and 15 mg/mL of tartaric acid, in the range of 1 and 5 mg/mL of sodium hydroxide, in the range of about 0.4 and 0.5 mg/mL of an antioxidant, in the range of about 0.001 to 0.010 mL/mL of a pH lowering agent, wherein the antioxidant comprises sodium bisulfite and/or sodium metabisulfite, and wherein the composition comprises about 3% or less total impurities after 6 months of storage at between 23° C. and 32° C. and between 55% RH and 70% RH.

2. The composition of claim 1, wherein the tonicity regulating agent comprises sodium chloride.

3. The composition of claim 1, wherein the pH lowering agent comprises hydrochloric acid.

4. The composition of claim 1, further comprising a solvent.

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