Amarin Corp Plc (AMRN)

[HDGabor]

N-

I understand it that statutory exclusivity has no teeth

You understand correctly.

New drug product exclusivity.
...
If a supplemental NDA:
...
Contained reports of new clinical investigations (other than bioavailability studies) that were conducted or sponsored by the applicant that were essential to approval of the supplemental NDA, for a period of 3 years after the date of approval of the supplemental application, the Agency will not approve a 505(b)(2) application or an ANDA for a change, or an ANDA submitted pursuant to an approved petition under section 505(j)(2 (C) of the Federal Food, Drug, and Cosmetic Act that relies on the information supporting a change approved in the supplemental NDA

The FDA will not approve any ANDA for / with R-IT indication till 12/2022 ... but the MARINE indication is not protected by any regulatory exclusivity.

Best,
G