Amarin Corp Plc (AMRN)

[Biobillionair]

North- I only have the MSDS here:

https://www.hikma.com/products/us-products/

It lists contents of 60-80% Icosapent Ethyl, >10% - < 25% 1,4-anhydro-D-glucitol, and >10% - <25% Glycerol, but it does not list tocopherol as antioxidant. Someone claims the H bottle does state it contains tocopherol, this is important because the FDA RLD guidance states it must contain tocopherol as antioxidant. This seems to “infringe” on claim 13.

1,4-anhydro-D-glucitol is otherwise known as sorbitan https://pubchem.ncbi.nlm.nih.gov/compound/1_4-Anhydro-D-glucitol. Sorbitan can literally be a polyoxyethylene see here: https://pubchem.ncbi.nlm.nih.gov/compound/Polyoxyethylene-sorbitan-monooleate

The proof will be ascertained by a chemical analysis of H API; this is most definitely being done by Amarin. I speculate Amarin’s composition patent included the food grade surfactants that are key to prevent the short chained Icosapent Ethyl molecules from tangling which would decrease the surface area for pancreatic lipases to react. Does H API contain at least one polyoxyethlene-polyoxypropylene block copolymer* and the patented tocopherol antioxidant**? I’m speculating YES.



*
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.

**
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.

BB