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BioInvestor3

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BioInvestor3

Re: Number sleven post# 386076

Friday, 08/12/2022 11:25:02 AM

Friday, August 12, 2022 11:25:02 AM

Post# of 423882
Patents do not come into play with the FDA, they have nothing to do with them. Generics usually file for an ANDA long before patents expire, just like Hikma did.
The FDA will advise there is a patent in force but that doesn't stop anyone from filing a ANDA or a 505(b)(2), but gaining exclusivity will stop them in their tracks.

Don't be focused on patents here, it's irrelevant just as it is now for the CV patent because the generics are eating their lunch in spite of it.

Obtaining a new formulation is all about gaining 3 year exclusivity, not new patents.
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