Why does this question matter?
Simply put, if AMR101 is designated as a New Chemical Entity (NCE) by the FDA, the product receives five years of market exclusivity after approval in the United States, regardless of the patent situation (sometimes referred to as Hatch-Waxman exclusivity). During this time the FDA will also not accept or approve ANDA's or 505(b)(2) applications for generic versions (except in case of ANDA with Paragraph IV certification that can be filed 1 year before NCE exclusivity expires).
It is important to note that a product can receive a 3 year period of market "data exclusivity" if it contains an active moiety (see definition below) that has been previously approved but has been the subject of new clinical investigation by the sponsor that were essential for approval. FDA will not approve any ANDA's during this time, but they can be filed. Amarin's efforts with AMR101 clearly meet this threshold, so I will not discuss this point further.
What does NCE mean?
Here is the definition according to FDA code: "New chemical entity means a drug that contains no active moiety that has been approved** by FDA in any other application submitted under section 505(b) of the act."
** Note that approved refers to the active ingredient alone or in combination (see #6 at this link)
In turn, the definition of active moiety is "the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance."
Are New Molecular Entity (NME) and NCE synonymns?
While they are very similar the definitions of NCE and NME are not identical. A new molecular entity is "a drug that contains an active moiety that has never been approved by FDA or marketed in the US"
Importantly, it is NCE status, and not NME status that governs the granting of the five year exclusivity period.
When is NCE status granted?
NCE status is granted upon approval of the New Drug Application (NDA). AMRN submitted its first NDA for AMR101 on or around 9/26/2011, so if the FDA accepts the filing for review, approval and potential NCE status could come in late March 2012 (if Priority Review) or late July 2012 (if Standard Review).
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