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Last Updated: December 12, 2025

List of Excipients in API ICOSAPENT ETHYL


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Excipients in NDA-approved (novel) drugs containing ICOSAPENT ETHYL

Glossary
Company Tradename Ingredient NDC Excipient Potential Generic Entry
Amarin Pharma Inc VASCEPA icosapent ethyl 52937-001 GELATIN
Amarin Pharma Inc VASCEPA icosapent ethyl 52937-001 GLYCERIN
Amarin Pharma Inc VASCEPA icosapent ethyl 52937-001 MALTITOL
Amarin Pharma Inc VASCEPA icosapent ethyl 52937-001 SORBITOL
Amarin Pharma Inc VASCEPA icosapent ethyl 52937-001 TOCOPHEROL
Amarin Pharma Inc VASCEPA icosapent ethyl 52937-001 WATER
>Company >Tradename >Ingredient >NDC >Excipient >Potential Generic Entry

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Excipients in ANDA-approved (generic) drugs containing ICOSAPENT ETHYL

Company Ingredient NDC Excipient
Hikma Pharmaceuticals USA Inc icosapent ethyl 0054-0508 .ALPHA.-TOCOPHEROL
Hikma Pharmaceuticals USA Inc icosapent ethyl 0054-0508 ALCOHOL
Hikma Pharmaceuticals USA Inc icosapent ethyl 0054-0508 AMMONIA
Hikma Pharmaceuticals USA Inc icosapent ethyl 0054-0508 ETHYL ACETATE
Hikma Pharmaceuticals USA Inc icosapent ethyl 0054-0508 FERROSOFERRIC OXIDE
Hikma Pharmaceuticals USA Inc icosapent ethyl 0054-0508 GELATIN
>Company >Ingredient >NDC >Excipient

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Detailed excipient profiles for ICOSAPENT ETHYL

Excipient focus: .ALPHA.-TOCOPHEROL

Excipient focus: .ALPHA.-TOCOPHEROL, DL-

Excipient focus: 1,4-SORBITAN

Excipient focus: ALCOHOL

Excipient focus: AMMONIA

Excipient focus: BUTYL ALCOHOL

Excipient focus: DIMETHICONE

Excipient focus: DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER

ICOSAPENT ETHYL drug variants not containing DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER

Company Ingredient NDC
Hikma Pharmaceuticals USA Inc icosapent ethyl 0054-0508
Teva Pharmaceuticals Inc icosapent ethyl 0480-0126
Northstar Rx LLC icosapent ethyl 16714-636
Camber Pharmaceuticals Inc icosapent ethyl 31722-298
Softgel Healthcare Private Limited icosapent ethyl 35916-1738
AvKARE icosapent ethyl 42291-032
>Company >Ingredient >NDC

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Excipient focus: ETHYL ACETATE

Excipient focus: FERROSOFERRIC OXIDE

Excipient focus: GELATIN

Excipient focus: GLYCERIN

Excipient focus: HYPROMELLOSES

Excipient focus: ISOPROPYL ALCOHOL

Excipient focus: LECITHIN, SOYBEAN

Excipient focus: LIGHT MINERAL OIL

Excipient focus: MALTITOL

Excipient focus: MANNITOL

Excipient focus: MEDIUM-CHAIN TRIGLYCERIDES

Excipient focus: NITROGEN

Excipient focus: NONCRYSTALLIZING SORBITOL SOLUTION

Excipient focus: POLYETHYLENE GLYCOL

Excipient focus: POLYETHYLENE GLYCOL 400

Excipient focus: POLYVINYL ACETATE PHTHALATE

Excipient focus: PROPYLENE GLYCOL

ICOSAPENT ETHYL drug variants not containing PROPYLENE GLYCOL

Company Ingredient NDC
Softgel Healthcare Private Limited icosapent ethyl 35916-1738
Amarin Pharma Inc icosapent ethyl 52937-001
Bryant Ranch Prepack icosapent ethyl 63629-8247
Qilu Pharmaceutical Co Ltd icosapent ethyl 67184-0582
Zydus Pharmaceuticals USA Inc icosapent ethyl 70710-1738
Softgel Healthcare Private Limited icosapent ethyl capsules 35916-0958
>Company >Ingredient >NDC

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Excipient focus: SHELLAC

Excipient focus: SILICON DIOXIDE

Excipient focus: SODIUM LAURYL SULFATE

Excipient focus: SORBITAN

Excipient focus: SORBITOL

Excipient focus: TITANIUM DIOXIDE

Excipient focus: TOCOPHEROL

Excipient focus: WATER

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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