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HDGabor

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HDGabor

Re: Number sleven post# 285046

Thursday, 07/09/2020 10:45:15 AM

Thursday, July 09, 2020 10:45:15 AM

Post# of 426271
N-

Half of Hikma's exclusivity period is gone

Nope. Exclusivity period will be running after final court decision (CAFC ... SC does not matter). Hikma has to launch within 75 days after CAFC Order (if it is final and will not be a remand) to avoid forfeit of 180-days exclusivity.

Not sure what value our reduce-it exclusivity has in the real world. Technically we have it but the carve out rules would seem to make it meaningless.

Exactly. Without CAFC win or without vacatur (0.01% probability) the R-IT label value is meaningless.

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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