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You are correct, Amarin essentially has nothing until the FDA decides...you are also correct the FDA will not accept Generics until this determination is done.
Vascepa is approved to treat high Trigs > 500 Marine NDA 505b2. 505b2 can be elgiable for NCE, the application does however use data from another company to get approval. from memory I think they used some Epadel info from Japan.
Anchor indication was a sNDA "riding" on the back of Marine NDA.
I've alway expressed, mistakenly now, that REDUCE-IT would also be sNDA.
The theory I propose, is REDUCE-IT will be a completely separate application than Marine. REDUCE-IT will be 505b1 application relying on all Amarin safety data from 3 clinical trials, MARINE, ANCHOR and REDUCEIT. Amarin may request 5 years of NCE at this time.
It's very possible at this time the FDA deny's Amarin again as Icosapent Ethyl has already been approved for Marine.
Essentially, Vascepa will never gain the benefits of exclusivity.
Or the FDA gives Amarin NCE at REDUCE-IT approval.
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