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Post# of 426566
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HDGabor

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HDGabor

Re: sts66 post# 279548

Thursday, 06/11/2020 5:48:23 PM

Thursday, June 11, 2020 5:48:23 PM

Post# of 426566
sts-

they filed ANDAs in 2016 when the 5 yr NCE exclusivity expired.

Erm....no..... they filed as soon as possible:
(i) first in 2014, shortly after FDA NME determination. (These were "vacated" due to NCE determination).
(ii) in 2016 ASAP ... on July 26, 2016 (ON the 4th anniversary of V approval, July 26, 2012) ... 5 yr NCE exclusivity expired in 2017.

V was approved in 2011

V was approved in 2012.

Other dates are correct ...

Best,
G

Disclosure: I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for it.

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