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Number sleven

06/26/25 4:48 PM

#436983 RE: TalShu #436982

TalShu, Both label indications are separate. Protected by different patients. Do you think FDA would require us to apply for both indications?
Sleven,
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hayward

06/26/25 5:06 PM

#436984 RE: TalShu #436982

TalShu

I am not trying to argue I just replied to your post saying

LR-EtEPA will enter a market where generic competition and other lipid-lowering therapies are present. Key competitors/alternatives include:

• Generic Icosapent Ethyl – multiple generic companies (Hikma, Dr. Reddy’s, Teva, Apotex) produce 1-gram EPA capsules that are AB-rated to Vascepa. They are priced lower and will be the main alternative. LR-EtEPA must differentiate clearly (which it can on dosing convenience and possibly slightly better outcomes). Generics will continue to capture cost-sensitive segments and patients in health systems that automatically substitute generics.

That is why I asked if Amrian could NOT list LR-EtEPA as a Lipid-lowering therapy only for CVD or are you saying CVD and Lipid-lowering therapy are the same ? If so the generics cannot have it both ways as you state above TIA

Michael