IP Library Granted Patent US 10,220,013
Granted Patent B2
US 10,220,013 · App. 15/273,430 · Granted Mar 5, 2019

Methods of treating mixed dyslipidemia

Inventors: Ian Osterloh (Kent, GB); Pierre Wicker (Mystic, CT); Rene Braeckman (Richboro, PA); Paresh Soni (Mystic, CT); Mehar Manku (Birminham, GB)
Assignee: Amarin Pharmaceuticals Ireland Limited
A61K31/202A61K9/48A61K31/222A61K31/232A61K31/40A61K31/505A61K45/06A61K47/22A61K47/26A61K47/34A61K31/74
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Quick Facts
Patent No.
US 10,220,013
App. No.
15/273,430
Granted
Mar 5, 2019
Kind
B2
Abstract

The present disclosure relates to, inter alia, methods of treating mixed dyslipidemia with ethyl eicosapentaenoate.

Claims (20)

1. A pharmaceutical composition comprising (a) an omega-3 polyunsaturated fatty acid (PUFA) comprising eicosapentaenoic acid (EPA) or a derivative of EPA, docosahexaenoic acid (DHA) or a derivative of DHA, and (b) at least one polyoxyethylene-polyoxypropylene block copolymer.

2. The pharmaceutical composition of claim 1 further comprising at least one additional fatty acid selected from the group consisting of linolenic acid (LA), derivative of LA, arachidonic acid (AA), derivative of AA, alpha-linolenic acid (ALA), derivative of ALA, stearadonic acid (STA), derivative of STA, eicosatrienoic acid (ETA), derivative of ETA, docosapentaenoic acid (DPA), derivative of DPA, or combinations thereof.

3. The pharmaceutical composition of claim 1 wherein the derivative of EPA is ethyl-EPA.

4. The pharmaceutical composition of claim 1 wherein the derivative of DHA is ethyl-DHA.

5. The pharmaceutical composition of claim 1 comprising a mixture of EPA or a derivative of EPA and DHA or a derivative of DHA, in a ratio of EPA or a derivative of EPA to DHA or a derivative of DHA from greater than about 2:1 to about 19:1, wherein the EPA or a derivative of EPA and DHA or a derivative of DHA in combination comprise more than about 50% by weight of total fatty acids present in the pharmaceutical composition.

6. The pharmaceutical composition of claim 1 comprising a mixture of EPA or a derivative of EPA and DHA or a derivative of DHA, wherein the EPA or a derivative of EPA comprises about 50% by weight of total fatty acids present in the pharmaceutical composition and the DHA or a derivative of DHA comprises about 20% by weight of total fatty acids present in the pharmaceutical composition.

7. The pharmaceutical composition of claim 1 wherein the pharmaceutical composition further comprises at least one surfactant selected from the group consisting—a polysorbate, a poloxamer, or combinations thereof.

8. The pharmaceutical composition of claim 7 wherein the at least one polysorbate is present in an amount from about 0.25% to about 15% by weight of the pharmaceutical composition.

9. The pharmaceutical composition of claim 8 wherein the at least one polysorbate is Polysorbate 80.

10. The pharmaceutical composition of claim 9 wherein the at least one poloxamer is present in an amount from about 0.25% to about 15% by weight of the composition.

11. The pharmaceutical composition of claim 1 wherein the pharmaceutical composition comprises a mixture of Polysorbate 80 and the polyoxyethylene-polyoxypropylene block copolymer.

12. The pharmaceutical composition of claim 1 further comprising at least one antioxidant.

13. The pharmaceutical composition of claim 12 wherein the at least one antioxidant is selected from the group consisting of tocopherol, lecithin, citric acid, and ascorbic acid.

14. The pharmaceutical composition of claim 13 wherein the tocopherol comprises from about 0.0001% to about 5% of the total weight of the pharmaceutical composition.

15. The composition of claim 1 , wherein the omega PUFA is in an amount between about 50% and about 95%, by weight.

16. The composition of claim 1 , wherein the omega-3 PUFA is present in an amount of about 50 mg to about 5000 mg.

17. The composition of claim 1 , wherein the composition is administered to provide a daily dose of omega-3 PUFA in an amount of about 1 mg to about 10,000 mg.

18. The composition of claim 7 , wherein the at least one surfactant comprises polyoxyethylene fatty acid glyceride and/or polyoxyethylene fatty acid oil.

19. The composition of claim 7 , wherein the at least one surfactant comprises polyoxyethylene castor oil, polyoxyethylene hydrogenated castor oil, polyoxyethylene sorbitan esters, or combinations thereof.

20. The composition of claim 7 , wherein the surfactant is in an amount between about 0.25% and about 15%, by weight.

Assignments (3)
RELEASE OF SECURITY INTEREST Recorded Nov 19, 2020
From: CPPIB CREDIT EUROPE S.À R.L.
To: AMARIN PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 054484/0552 →
SECURITY INTEREST Recorded Dec 21, 2017
From: AMARIN PHARMACEUTICALS IRELAND LIMITED
To: CPPIB CREDIT EUROPE S.À R.L.
Reel/Frame 044938/0257 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2016
From: OSTERLOH, IAN; WICKER, PIERRE; BRAECKMAN, RENE; SONI, PARESH; MANKU, MEHAR
To: AMARIN PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 039846/0017 →
Continuity (8)
Continuation 14704329 · May 5, 2015
Continuation 14175602 · Feb 7, 2014
Continuation 13898447 · May 20, 2013
Continuation 13540319 · Jul 2, 2012
Continuation 13417899 · Mar 12, 2012
Continuation 13266085
Provisional Application 61173759 · Apr 29, 2009
Related Publication 20170014366A1 · Jan 19, 2017
Cited By (2)
US 12,246,003 US 12,427,134