Granted Patent
B2
US 12,280,024 · App. 18/477,161 · Granted Apr 22, 2025
Epinephrine formulations
Inventors:
Suketu Sanghvi (Kendall Park, NJ); Vinayagam Kannan (Morris Plains, NJ); Matthew Kenney (New Haven, MI)
Assignee:
ENDO OPERATIONS LIMITED
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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.
Claims (12)
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.
Assignments (8)
SHORT FORM INTELLECTUAL PROPERTY SECURITY AGREEMENT
Recorded Nov 6, 2025
From: PH HEALTH LIMITED
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS COLLATERAL AGENT
Reel/Frame 073508/0830 →
RELEASE OF SECURITY INTEREST IN CERTAIN PATENTS PREVIOUSLY RECORDED AT REEL/FRAME (068461/0692)
Recorded Aug 4, 2025
From: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
To: ENDO OPERATIONS LIMITED
Reel/Frame 072343/0897 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jul 22, 2025
From: ENDO OPERATIONS LIMITED
To: PH HEALTH LIMITED
Reel/Frame 072131/0540 →
SECURITY INTEREST
Recorded Jul 22, 2024
From: ENDO BIOLOGICS LIMITED; ENDO OPERATIONS LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 068469/0001 →
SECURITY INTEREST
Recorded Jul 19, 2024
From: ENDO BIOLOGICS LIMITED; ENDO OPERATIONS LIMITED
To: GOLDMAN SACHS BANK USA
Reel/Frame 068461/0692 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 27, 2024
From: ENDO USA, INC.
To: ENDO OPERATIONS LIMITED
Reel/Frame 067245/0492 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 23, 2024
From: PAR PHARMACEUTICAL, INC.
To: ENDO USA, INC.
Reel/Frame 067203/0686 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Oct 2, 2023
From: SANGHVI, SUKETU; KANNAN, VINAYAGAM; KENNEY, MATTHEW
To: PAR PHARMACEUTICAL, INC.
Reel/Frame 065095/0638 →
Continuity (9)
Continuation
14818121
· Aug 4, 2015
Continuation
14657990
· Mar 13, 2015
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