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Re: gburgin post# 88739

Wednesday, 01/25/2017 1:26:50 PM

Wednesday, January 25, 2017 1:26:50 PM

Post# of 461261
sokol, I need to modify that question. When you said the statement below is it in the context of the drug being within the 5 or 7 year exclusivity for a newly approved drug? If so then it makes sense. My previous question was more general in terms of what happens AFTER the exclusivity ends. I assume at that point a method of use patent on file at the FDA is not going to stop generics from going after other indications.

"Patents too are listed in the FDA's Orange Book in the FDA's ministerial capacity. As long as any patent for AVXL 2-73 is listed in the FDA's Orange Book, it will not authorize a generic version of AVXL 2-73 for any use."
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