Tuesday, August 18, 2015 3:02:26 PM
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
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
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