IP Library › Granted Patent US 12,440,458
Granted Patent B2
US 12,440,458 · App. 17/685,090 · Granted Oct 14, 2025

Epinephrine formulations

Inventors: Suketu Sanghvi (Kendall Park, NJ); Vinayagam Kannan (Morris Plains, NJ); Matthew Kenney (New Haven, MI)
Assignee: PH HEALTH LIMITED
A61K31/137A61K9/0019A61K9/08A61K47/12A61K47/20A61K9/0014A61K9/0048A61K9/0073
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Quick Facts
Patent No.
US 12,440,458
App. No.
17/685,090
Granted
Oct 14, 2025
Kind
B2
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 (42)

1. A pre-filled syringe containing a composition, the composition comprising:

epinephrine and/or salts thereof,

a tonicity regulating agent,

a pH raising agent,

an antioxidant comprising glutathione,

a pH lowering agent,

a transition metal complexing agent, and

water.

2. The pre-filled syringe of claim 1 , wherein the tonicity regulating agent comprises sodium chloride.

3. The pre-filled syringe of claim 1 , wherein the pH raising agent comprises tartaric acid and sodium hydroxide.

4. The pre-filled syringe of claim 1 , wherein the pH lowering agent comprises hydrochloric acid.

5. The pre-filled syringe of claim 1 , wherein the transition metal complexing agent comprises EDTA.

6. The pre-filled syringe according to claim 1 , wherein the composition comprises about 20% or less total impurities after 1 month of storage in accelerated storage conditions.

7. The pre-filled syringe according to claim 1 , wherein the composition comprises about 20% or less total impurities after 2 months of storage in accelerated storage conditions.

8. The pre-filled syringe according to claim 1 , wherein the composition comprises about 20% or less total impurities after 3 months of storage in accelerated storage conditions.

9. The pre-filled syringe according to claim 1 , wherein the composition comprises about 10% or less total impurities after 1 month of storage in accelerated storage conditions.

10. The pre-filled syringe according to claim 1 , wherein the composition comprises about 10% or less total impurities after 2 months of storage in accelerated storage conditions.

11. The pre-filled syringe according to claim 1 , wherein the composition comprises about 10% or less total impurities after 3 months of storage in accelerated storage conditions.

12. A pre-filled syringe containing a composition, the composition comprising:

epinephrine and/or salts thereof,

a tonicity regulating agent comprising sodium chloride,

a pH raising agent comprising tartaric acid and sodium hydroxide,

an antioxidant comprising glutathione,

a pH lowering agent comprising hydrochloric acid,

a transition metal complexing agent comprising EDTA, and

water.

13. The pre-filled syringe according to claim 12 , wherein the composition comprises about 20% or less total impurities after 1 month of storage in accelerated storage conditions.

14. The pre-filled syringe according to claim 12 , wherein the composition comprises about 20% or less total impurities after 2 months of storage in accelerated storage conditions.

15. The pre-filled syringe according to claim 12 , wherein the composition comprises about 20% or less total impurities after 3 months of storage in accelerated storage conditions.

16. The pre-filled syringe according to claim 12 , wherein the composition comprises about 10% or less total impurities after 1 month of storage in accelerated storage conditions.

17. The pre-filled syringe according to claim 12 , wherein the composition comprises about 10% or less total impurities after 2 months of storage in accelerated storage conditions.

18. The pre-filled syringe according to claim 12 , wherein the composition comprises about 10% or less total impurities after 3 months of storage in accelerated storage conditions.

19. The pre-filled syringe according to claim 12 , wherein the antioxidant consists of glutathione.

20. A pre-filled syringe containing a composition, the composition comprising:

0.62 mM epinephrine and/or salts thereof,

133.47 mM sodium chloride,

14.99 mM tartaric acid,

25 mM sodium hydroxide,

4.88 mM glutathione,

0.69 mM hydrochloric acid,

0.54 mM EDTA, and

water.

Assignments (9)
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 3, 2025
From: ENDO OPERATIONS LIMITED
To: PH HEALTH LIMITED
Reel/Frame 072144/0289 →
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 Jun 27, 2022
From: SANGHVI, SUKETA; KANNAN, VINAYAGAM; KENNEY, MATTHEW
To: PAR PHARMACEUTICAL, INC.
Reel/Frame 060317/0882 →
Continuity (8)
Continuation 16817253 · Mar 12, 2020
Continuation 16258204 · Jan 25, 2019
Continuation 15969500 · May 2, 2018
Continuation 15455991 · Mar 10, 2017
Continuation In Part 14863112 · Sep 23, 2015
Continuation 14818121 · Aug 4, 2015
Continuation 14657990 · Mar 13, 2015
Related Publication 20230100523A1 · Mar 30, 2023
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