Amarin Corp Plc (AMRN)

[HDGabor]

c-

the 180 days definition should start from dc ruling

Nope, CAFC ruling matters

(AA) In an infringement action brought against that applicant with respect to the patent or in a declaratory judgment action brought by that applicant with respect to the patent, a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the patent is invalid or not infringed.

Please note: I saw / found "debate" about DC vs CAFC decision (as triggering event) but I do not consider this topic as a relevant ... did not make a full DD

not launch

By launch

The FD&C Act provides that the 180-day exclusivity period is triggered by “first commercial marketing of the drug (including the commercial marketing of the listed drug) by any first applicant

In this case:

Part I (earlier):
- ANDA approval + 75 days: Q3 2020 (exact date is not relevant due to 30 month
- end of 30 month stay: Jan 26, 2020

Part II (later):
- earlier of Part I: Jan 26, 2020
- a final decision (from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) + 75 days: (let's say) Q1 2021

otherwise, what if first ANDA receiver dragged their feet and never came to market? Then all other applicants have to wait forever?

Hikma has 75 days after the triggering event to launch ... if no launch: FDA determines that the first applicant has forfeited exclusivity under the “failure to market” provision

Also, based on your quote here, does this mean each one in the chain will has a 180 days excluding upon subsequent ANDA filers?Hikma got 180 first, then R got 180 in front Teva?

Nope. One 180 days exclusivity exists (if the patent was not expired but invalidated ... in case of expired patent no 180-day exclusivity).

So amrn has not filed suit yet, filed but has not realesed cc yet, or settled already? Silence...

Deadline: May 6 + 45 days ...

Best,
G