Amarin Corp Plc (AMRN)

[Biobillionair]

Exclusivity for Vascepa will start at OB's date of NCE. Judge Moss has recently ruled on when exclusivity should start for an approved drug. Amarin's application is still incomplete due to lack of exclusivity. This is a substantial issue that has prevented Amarin from valuing drug product life cycle and preventing any co-marketing or BO deals.

Moss- "Some requirements that may remain after the FDA sends such a letter are ministerial and do not affect the finality of that approval. In those circumstances—including when the manufacturer will have to finalize a label to reflect DEA scheduling—the FDA does not need to consider further any aspect of the NDA and so it treats its “approval” as final. In other cases, however, the requirements that remain are substantial and will require further substantive review and approval. In those cases, the agency expressly requires further action in its approval letter as a signal that the FDA has concluded that its process is not yet completed."


Vascepa's post approval papers:

***Determination of whether this application qualifies for 3 or 5 years of exclusivity was not finalized by the goal date. The final decision will be made post-approval and this form will be completed at that time.***

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000AdminCorres_edt.pdf

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