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Williams4076

08/18/15 3:02 PM

#56836 RE: louieblouie #56815

LB-
Are you talking about the patent extension? Because that could also be an issue. Or 30 Month stay? IMO Vascepa will get assign some exclusivity for REDUCE-IT. Unlikely 5 but if 3 (for new study) generics can file with exclusivity being assigned at approval. In the unlikely event FDA decides to award 5 years then generics can't file for 4 years and then this starts the 30 Month stay.

Approval 2019 with 3 years
2020
2021
2022
(30 Month stay can be filed after approval)

Approval 2019 with 5 years
2020
2021
2022
2023
2024
(30 Month stay with paragraph IV can only be filed after 4th year 2023)

But let's be clear Amarin has a fairly high patent wall building for Rx of CVD and EPA.

BB