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.
Keep reading below the jump for the rest of my discussion and analysis:
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.
Keep reading below the jump for the rest of my discussion and analysis:
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