IP Library Granted Patent US 10,610,506
Granted Patent B2
US 10,610,506 · App. 15/430,233 · Granted Apr 7, 2020

Compositions comprising ornithine and phenylacetate or phenylbutyrate for treating hepatic encephalopathy

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Quick Facts
Patent No.
US 10,610,506
App. No.
15/430,233
Granted
Apr 7, 2020
Kind
B2
Abstract

The present invention relates to use of ornithine in the manufacture of a medicament for use in combination with at least one of phenylacetate and phenylbutyrate for preventing or treating liver decompensation or hepatic encephalopathy. The invention also relates to use of at least one of phenylacetate and phenylbutyrate in the manufacture of a medicament for use in combination with ornithine for preventing or treating liver decompensation or hepatic encephalopathy.

Claims (20)

1. A pharmaceutical composition comprising ornithine or a physiologically acceptable salt thereof and at least one of phenylacetate or phenylbutyrate or a physiologically acceptable salt thereof, wherein the pharmaceutical composition comprises no other amino acid, wherein the ornithine or a physiologically acceptable salt thereof and at least one of phenylacetate or phenylbutyrate or a physiologically acceptable salt thereof are in a weight ratio from 2:1 to 1:2, and wherein the composition is formulated for intravenous administration.

2. The pharmaceutical composition of claim 1 , wherein the ornithine or a physiologically acceptable salt thereof and at least one of phenylacetate or phenylbutyrate or a physiologically acceptable salt thereof are in a weight ratio of about 1:1.

3. The pharmaceutical composition of claim 1 , comprising from 1 g to 50 g of ornithine or a physiologically acceptable salt thereof and from 1 g to 50 g of phenylacetate or phenylbutyrate or a physiologically acceptable salt thereof.

4. The pharmaceutical composition of claim 1 , comprising from 5 g to 30 g of ornithine or a physiologically acceptable salt thereof and from 5 g to 30 g of phenylacetate or phenylbutyrate or a physiologically acceptable salt thereof.

5. The pharmaceutical composition of claim 1 , comprising a physiologically acceptable salt of ornithine and a physiologically acceptable salt of at least one of phenylacetate or phenylbutyrate.

6. The pharmaceutical composition of claim 5 , comprising ornithine hydrochloride and at least one of sodium phenylacetate or sodium phenylbutyrate.

7. The pharmaceutical composition of claim 1 , further comprising a pharmaceutically acceptable carrier or diluent.

8. The pharmaceutical composition of claim 7 , comprising sterile water.

9. The pharmaceutical composition of claim 1 , comprising a physiologically acceptable salt of ornithine and a physiologically acceptable salt of phenylacetate.

10. The pharmaceutical composition of claim 9 , comprising ornithine hydrochloride and sodium phenylacetate.

11. The pharmaceutical composition of claim 9 , further comprising a pharmaceutically acceptable carrier or diluent.

12. The pharmaceutical composition of claim 11 , comprising sterile water.

13. The pharmaceutical composition of claim 1 , comprising a physiologically acceptable salt of ornithine and a physiologically acceptable salt of phenylbutyrate.

14. The pharmaceutical composition of claim 13 , comprising ornithine hydrochloride and sodium phenylbutyrate.

15. The pharmaceutical composition of claim 13 , further comprising a pharmaceutically acceptable carrier or diluent.

16. The pharmaceutical composition of claim 15 , comprising sterile water.

17. A pharmaceutical composition consisting of ornithine or a physiologically acceptable salt thereof, at least one of phenylacetate and phenylbutyrate or a physiologically acceptable salt, and a pharmaceutical acceptable carrier, wherein the ornithine or a physiologically acceptable salt thereof and at least one of phenylacetate or phenylbutyrate or a physiologically acceptable salt thereof are in a weight ratio from 2:1 to 1:2, and wherein the composition is formulated for intravenous administration.

18. The pharmaceutical composition of claim 17 , consisting of ornithine or a physiologically acceptable salt thereof, and phenylacetate or a physiologically acceptable salt, and a pharmaceutical acceptable carrier.

19. The pharmaceutical composition of claim 17 , consisting of ornithine or a physiologically acceptable salt thereof, and phenylbutyrate or a physiologically acceptable salt, and a pharmaceutical acceptable carrier.

20. The pharmaceutical composition of claim 3 , comprising from 1 g to 50 g of ornithine or a physiologically acceptable salt thereof and from 1 g to 50 g of phenylacetate or a physiologically acceptable salt thereof in a weight ratio of about 1:1.

Assignments (8)
RELEASE OF SECURITY INTEREST Recorded Aug 14, 2025
From: ACQUIOM AGENCY SERVICES LLC
To: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
Reel/Frame 072324/0740 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 060434, FRAME 0536 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; VTESSE LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; SUCAMPO PHARMA AMERICAS LLC
Reel/Frame 065601/0347 →
RELEASE OF SECURITY INTERESTS IN PATENTS AT REEL 060389/FRAME 0913 Recorded Nov 15, 2023
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); MALLINCKRODT LLC; MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 065583/0465 →
SECURITY INTEREST Recorded Nov 15, 2023
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
To: ACQUIOM AGENCY SERVICES LLC
Reel/Frame 065595/0376 →
NOTICE OF GRANT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY Recorded Jun 22, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY
To: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 060434/0536 →
SECURITY INTEREST Recorded Jun 17, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 060389/0913 →
CHANGE OF NAME Recorded Nov 27, 2019
From: UCL BUSINESS PLC
To: UCL BUSINESS LTD
Reel/Frame 051144/0324 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 5, 2017
From: JALAN, RAJIV; JALAN, KAMAL NAYAN
To: UCL BUSINESS PLC
Reel/Frame 043800/0679 →