Replies to post #16623 on Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

CW has said on multiple occasions that MNTA either has first-filer status or shared first-filer status. For Paragraph-IV challenges, it’s the submission date (not the FDA’s acceptance date for review) that determines first-filer status, and CW claims that MNTA submitted on the first day possible (as explained in my previous post).

All this is probably moot in any case because the FDA can say that nobody is entitled to 180-day exclusivity insofar as no one was able to launch within 30 months.

[alternatepatel]

First Notice Letter Dates:


jbog, we can't know the filing date for sure. Here's all I could find:

Company First Notice Letter Date ANDA No.
DRL 1-Aug-14 206767
Sandoz-Momenta 27-Aug-14 206921
Mylan 28-Aug-14 206936
Synthon 8-Oct-14 206873
Amneal 23-Jan-15 207553
Biocon 10-Mar-16 209001

I think Dew is right. Generics couldn't file P-IV ANDA without OB listing of patents. However, DRL's acceptance / first notice letter date is earlier by almost 1 month, still they aren't a threat IMO.