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Biotech / Medical : Momenta Pharmaceuticals Inc.
MNTA 52.480.0%Oct 2 5:00 PM EST

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To: tuck who wrote (3014)10/4/2017 2:22:04 PM
From: DewDiligence_on_SI  Read Replies (1) of 3027
 
I'm pretty sure the only issue is whether the FDA approves a 40mg generic from one of the first-filer applicants (including NVS/MNTA) within six months of yesterday; if they do, all approved 40mg products from first-filers will share the (remaining amount of) 180-day H-W exclusivity.

If the above is true, 180-day H-W exclusivity will end up constraining nobody—unless FDA approves a 40mg generic in the next six months from a non-first-filer applicant, which is highly unlikely, IMO.

Yes, TEVA could (and probably would) launch a 40mg AG if there are multiple approved generics.
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